[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atopic-dermatitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atopic-dermatitis":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,167,0,25,[9,51,78,106,139,167,191,212,236,259,281,304,329,353,375,399,420,448,478,502,523,552,571,600,619],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100613161","evaluating-the-safety-and-tolerability-of-baricitinib-in-patients-with-job-syndrome-with-lupus-like-disease-andor-atopic-dermatitis-100613161",false,"NCT07262983","Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and\u002For Atopic Dermatitis","A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients With Job s Syndrome With Lupus-like Disease and\u002For Atopic Dermatitis","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Must be able to understand and provide informed consent or assent.\n2. Aged \\>=12 years.\n3. Documented STAT3 variant causing hyper-IgE syndrome.\n4. Enrollment in NIH protocol 00-I-0159, Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES).\n\n   a. Presence of SLE and\u002For AD as follows: SLE patients should meet either Systemic Lupus International Collaborating Clinics (SLICC) or 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) SLE classification criteria. AD is defined as EASI tool score \\>=16 and body surface area tool score of 10% at screening.\n5. Ability to take oral medication and be willing to adhere to the study intervention regimen.\n6. For individuals on glucocorticoids, the dose must be less than 10 mg daily and stable for the 30 days prior to Day 0.\n7. For individuals on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for 90 days prior to Day 0. The maximum allowed dose is hydroxychloroquine 400 mg\u002Fday or 6.5 mg\u002Fkg\u002Fday, whichever is greater. The maximum allowed dose for chloroquine phosphate is 500 mg daily, and for quinacrine is 100 mg daily.\n8. Individuals may be on lipid-lowering medications if initiated at least 90 days prior to Day 0, and the dose must be stable for 30 days prior to Day 0.\n9. Individuals of reproductive potential must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy while on study drug. Acceptable methods of contraception include:\n\n   * Intrauterine device (IUD)\n   * Bilateral tubal ligation\n   * Abstinence\n   * Vasectomized partner\n   * Hormonal contraception used in combination with barrier method: progestogen containing (oral, intravaginal, transdermal) or progestogen-only (oral, injectable, implantable) starting 30 days prior to initiation of baricitinib\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known history of hypersensitivity to baricitinib or other JAK inhibitors.\n2. Current or recent use of any investigational drug\u002Fintervention (within 6 months or 5 half-lives, whichever is longer, prior to Day 0) except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.\n3. Scheduled to participate in another clinical study involving an investigational drug during the course of this study.\n4. Use of systemic immunosuppressive or immune-modulating agents within 90 days prior to Day 0, except systemic steroids \\\u003C=10 mg of prednisone equivalent per day.\n5. Current or prior treatment with rituximab in the 6 months prior to Day 0.\n6. Current treatment with methotrexate, mycophenolate mofetil, other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), belimumab, and other immunosuppressive biologics not otherwise specified herein. Participants previously on methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or belimumab, other immunosuppressive biologics, or DMARDs should have been withdrawn from the drug for at least 90 days prior to Day 0.\n7. Treatment with cyclophosphamide and pulse methylprednisolone within 6 months prior to Day 0.\n8. Hypercholesterolemia: Values after 8- to 12-hour fasting blood specimen: total cholesterol \\>250 mg\u002FdL or LDL \\>180 mg\u002FdL or hypertriglyceridemia (triglyceride \\>300 mg\u002FdL) within 90 days prior to Day 0.\n9. History of alcohol or drug abuse within 6 months prior to Day 0.\n10. Presence of 1 or more of the following clinically significant laboratory abnormalities:\n\n    1. Serum ALT \\>=3 times ULN.\n    2. Serum total bilirubin \\>=2 times ULN.\n    3. ANC \\\u003C=750 cells\u002FmicroL.\n    4. Hemoglobin \\\u003C=9.0 g\u002FdL.\n    5. Platelet count \\\u003C=100,000\u002FmicroL.\n    6. Serum creatinine \\>=2 times ULN.\n11. Planned or anticipated major surgical procedure during the study.\n12. Plans to receive any live vaccines within 1 month of the anticipated first dose of baricitinib.\n13. Known or suspected immune-dysregulatory disorders besides Job s syndrome, lupus-like disease, and\u002For AD.\n14. Active invasive opportunistic infections (eg, non-TB mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis) despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immune-compromised status as judged by the investigator.\n15. Known active TB. Participants with treated LTB will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease consultant and may become eligible for trial based on infectious disease consultant recommendations.\n16. Infection with HIV.\n17. Untreated infection with hepatitis B or C.\n18. Unwillingness to receive prophylactic entecavir (or similar), only for individuals with evidence of clearance of hepatitis B with positive hepatitis B core and surface antibody and negative hepatitis B surface antigen and PCR.\n19. BK or JC viremia at screening visit.\n20. Active infection that requires the use of oral or intravenous antimicrobials that remains unresolved at least 14 days prior to the administration of the first dose of study medication.\n21. Individuals with active renal or central nervous system disease or a high activity level in any organ system (except articular) that requires immediate immunosuppressive therapy as determined by the investigator.\n22. History of cancer, with the exceptions of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, provided the participant is in remission and curative therapy was completed at least 12 months prior to screening. History of other malignancies are also permitted provided that the individual is in remission and curative therapy was completed at least 5 years prior to screening.\n23. Planned or anticipated use of any prohibited medications and procedures during the study.\n24. Pregnancy or current breastfeeding.\n25. Currently receiving hemodialysis or peritoneal dialysis.\n26. Past or current medical problems or findings from physical examination, electrocardiogram, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. These may include, but are not limited to:\n\n    1. Known coronary artery aneurysm.\n    2. Known history of arterial or venous thrombosis or at high risk for clotting disorder.\n    3. Known history of PE or DVT in the past.\n    4. Psychiatric illness or history of medical non-compliance that the study team feels will make the individual unlikely to complete the study.\n    5. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the investigator, would jeopardize the individual s safety following exposure to the study drug.\n27. Individuals with known increased risk factors for MACE including a history of:\n\n    1. Ischemic heart disease (eg, history of acute myocardial infarction).\n    2. Heart failure.\n    3. Cardiomyopathy.\n    4. Severe valvular heart disease.\n    5. Significant arrhythmias.\n    6. Chronic renal failure.\n    7. Cerebrovascular accident or transient ischemic attack.\n    8. Uncontrolled diabetes mellitus.\n    9. Uncontrolled hypertension.\n    10. Current smokers or former smokers with less than 3 years since complete cessation and\u002For \\>20 pack-years of smoking history.\n28. History of idiopathic GI perforation or diverticulitis with high risk of perforation.\n29. Treatment with strong organic anion transporter 3 inhibitors (OAT3) (eg, probenecid) due to drug interactions.\n30. Uncontrolled thyroid disease as per principal investigator or medically responsible investigator.","ALL","12 Years","120 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nAutosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones. People with HIES often have lupus-like disease or atopic dermatitis (skin rash). Researchers want to know if a drug approved to treat other immune system diseases (baricitinib) can help people with HIES.\n\nObjective:\n\nTo test baricitinib in people with HIES with lupus-like disease or skin rash.\n\nEligibility:\n\nPeople aged 12 years and older with HIES with lupus-like disease or skin rash.\n\nDesign:\n\nParticipants will have 5 clinic visits, 4 remote visits, and 2 phone visits in 9 months.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of the speed and pressure of blood flow through their body: Blood pressure cuffs will be placed on each arm and leg; electrodes will be placed on the wrists and a microphone on the chest.\n\nThe study has a 3-month lead-in period. Participants will not take the study drug during this time. They will continue with their usual medical care. They will have 2 phone calls with the study team.\n\nBaricitinib is a tablet taken by mouth. Participants will take 1 or 2 tablets by mouth every day for 6 months. They will start with a low dose and may increase to a higher dose.\n\nBlood and urine tests will be repeated during each study visit. Other tests may also be repeated during some visits. A skin sample may also be taken....",[28,29,30,31,32],"Hyper IgE Syndrome From STAT3 Mutation","Job s Syndrome","HIES","Lupus","Atopic Dermatitis",[28,34,30,31,32,35,36,37],"Job s syndrome","Lupus-like Disease","JAK Inhibition","Janus Kinases","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":22},"2026-08-26",{"date":46,"type":22},"2030-10-01",{"name":48,"class":49},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100593206","phase-2-a-long-term-safety-and-efficacy-study-evaluating-apg777-in-atopic-dermatitis-100593206","NCT07003425","A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis","A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777","Inclusion Criteria:\n\n* Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol\n* Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777\n* Use the same non-prescription non-medicated emollient\u002Fmoisturizer of their choice from the last day of the Parent Study and throughout the LTE study\n\nExclusion Criteria:\n\n* Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient\n* Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study\n* Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study\n* Presence of dermatologic conditions and\u002For comorbidities that might confound the diagnosis of AD and\u002For interfere with study assessments\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria may apply","18 Years",{"count":60,"type":22},350,[62],"PHASE2","This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).\n\nThe LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.\n\nThis study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.",[32],[32,66,67,68],"APG777","Safety","Efficacy",{"date":41,"type":42},{"date":71,"type":42},"2025-05-14",{"date":73,"type":22},"2029-12",{"name":75,"class":76},"Apogee Therapeutics, Inc.","INDUSTRY",68,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100588944","phase-2-platform-study-to-evaluate-the-efficacy-and-safety-of-investigational-compounds-in-patients-with-moderate-to-severe-atopic-dermatitis-100588944","NCT06947993","Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis","Key Inclusion Criteria of the master protocol:\n\n* Able and willing to sign the informed consent (IC)\n* Patients with a diagnosis of AD and onset of disease for at least 1 year\n* Moderate to severe AD\n\nKey Exclusion Criteria of the master protocol:\n\n* Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)\n* Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG\n* Participant with any other active inflammatory skin disease\n* Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)\n* Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)\n\nAdditional inclusion and exclusion criteria may apply depending on the intervention specific requirements","100 Years",{"count":87,"type":22},224,[62],"This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).",[32],[92,93,94,95],"Atopic dermatitis","Dermatitis","Eczema","Moderate to severe","2026-08-18",{"date":98,"type":42},"2026-08-19",{"date":100,"type":42},"2025-05-16",{"date":102,"type":22},"2028-12-22",{"name":104,"class":76},"Novartis Pharmaceuticals",105,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":128,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":136,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":137,"locationsCount":4},"100374756","expanded-access-to-upadacitinib-100374756","NCT04159597","Expanded Access to Upadacitinib","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[115,116,117,32,118,119,120,121,122,123,124,125,126,127],"Crohn Disease","Ulcerative Colitis","Idiopathic Arthritis (Including sJIA, pJIA, or JPsA)","Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis","Non-radiographic Axial","Spondyloarthritis","Giant Cell Arteritis","Systemic Lupus Erythematosus","Alopecia Areata","Non Segmental Vitiligo","Hidradenitis Suppurativa",[129,130,131,132,133,134],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE",{"date":39,"type":42},{"name":138,"class":76},"AbbVie",{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":17,"minAge":147,"maxAge":85,"enrollmentInfo":148,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":4,"leadSponsor":165,"locationsCount":50},"100103147","studies-of-skin-microbes-in-healthy-people-and-in-people-with-skin-conditions-100103147","NCT00605878","Studies of Skin Microbes in Healthy People and in People With Skin Conditions","Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients","* INCLUSION CRITERIA:\n\nInclusion Criteria for all groups\n\nMust have a primary care professional who will continue standard of care\u002Fevaluation in tandem with the protocol to whom information and recommendations can be communicated.\n\nInclusion Criteria for Group 1: Healthy Volunteers\n\nAdult males or females aged 18-50 at time of enrollment.\n\nInclusion Criteria for Group 2: AD patients\n\nA. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24\n\nB. Moderate to severe AD SCORAD greater than or equal to 25(25)\n\nC. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of enrollment to serve as a target site.\n\nInclusion Criteria for Group 3: Healthy (pediatric) Controls\n\nA. Males or females 2-18 years of age.\n\nInclusion Criteria for Groups 4, 5, \\& 6: AD\u002FHIES\u002FWAS\u002FDOCK8 patients\n\nA. Must have mutation-proven diagnosis, with or without eczematous dermatitis.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for all groups:\n\n1. Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants \\\u003C 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.\n2. Any subjects who have cancer, and are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies within the previous 6 months.\n3. Any subject with a history of bone marrow transplant or gene therapy.\n\nExclusion Criteria specific for Group 2: AD patients\n\nA. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to body site sampling. Unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for greater than or equal to 7 days to small areas of skin intended for sampling. (Topical therapies\u002Femollients for AD may be continued to non-adjacent, nontarget sites.)\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nExclusion Criteria specific for Groups 4, 5, \\& 6: HIES\u002FWAS\u002FDOCK8 patients:\n\nA. Unable to remain off topical steroids and emollients for preferably 7 days but at least 24 hours prior to body site sampling.\n\nExclusion Criteria specific for Groups 1 \\& 3: Healthy Volunteers and Healthy (pediatric) Controls:\n\nA. Any subjects with unstable or uncontrolled or chronic medical conditions requiring treatment or hospitalization. Individual determinations will be made at the discretion of the medical investigator.\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nC. Other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of the cutaneous microbiome. Common transient conditions, such as acne, are permissible.\n\nD. Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals.\n\nE. Subjects with asthma.\n\n5\\. Any female with symptoms and\u002For serum hormone levels consistent with perimenopause",true,"2 Years",{"count":149,"type":22},530,"OBSERVATIONAL","This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.\n\nHealthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study.\n\nWe also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD.\n\nEligible participants undergo the following tests and procedures:\n\n* Medical family and medication history\n* Skin examination\n* Blood tests (research blood as well as serum IgE, and complete blood count)\n* Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1\u002F4-inch (5 mm) in diameter.\n* Nose swabs to analyze microbes.\n* Patients with eczema may have photographs of their skin taken to help monitor the skin rashes.\n\nParticipants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.",[94,32],[154,155,156,157,158,32,94,159,160],"Skin","Natural History","Microbiome","Bacteria","Atopic Dermatitis (Eczema)","Health Volunteer","HG","2026-08-15",{"date":96,"type":42},{"date":164,"type":42},"2008-01-22",{"name":166,"class":49},"National Human Genome Research Institute (NHGRI)",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":21},"100609549","phase-2-a-study-to-learn-about-study-medicine-called-pf-08049820-in-people-with-eczema-100609549","NCT07216027","A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema","A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS","Inclusion Criteria:\n\nParticipants must meet the following criteria:\n\n1. Are 18 to 64 years of age\n2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs\n3. Have moderate to severe AD as defined by the following at screening and baseline visits:\n\n   * Affected body surface area (BSA) greater than or equal to 10% and up to 60%;\n   * Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;\n   * Eczema Area and Severity Index (EASI) greater than or equal to 16;\n\n   AND\n\n   -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit\n4. Do not have a suitable prescribed medicine for AD.\n5. Body Mass Index (BMI) of 18 to 38 kg\u002Fm2 and a total body weight greater than 48 kg (106 lbs)\n\nExclusion Criteria:\n\nParticipants must not meet the following criteria:\n\n1. Have an infection that requires treatment\n2. Have other skin conditions other than AD\n3. Have severe uncontrolled asthma\n4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit","64 Years",{"count":176,"type":22},165,[62],"The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.\n\nThe study is seeking participants who:\n\n1. Are 18 to 64 years of age;\n2. Were confirmed to have AD at least 6 months ago;\n3. Do not have a suitable prescribed medicine for AD;\n4. Are considered by their doctors to have moderate to severe AD.\n\nThe study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.",[32,180],"Eczema, Atopic",[94,32],"2026-08-14",{"date":184,"type":42},"2026-08-17",{"date":186,"type":42},"2025-11-20",{"date":188,"type":22},"2028-02-02",{"name":190,"class":76},"Pfizer",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":50},"100585195","real-world-efficiency-of-abrocitinib-treatment-at-patients-with-moderate-to-severe-atopic-dermatitis-who-had-inadequate-response-to-previous-biologic-therapies-100585195","NCT06899204","Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.","A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis","This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study.\n\n9.2.1. Inclusion Criteria\n\nPatients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Participants who have chronic AD that has been present for ≥1 year before screening.\n2. Male and female patients aged \\>12 years at baseline.\n3. Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study\n4. Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and\u002For intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)\n5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board\u002Findependent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.\n6. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.\n\n9.2.2. Exclusion Criteria\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Patients, that currently have active forms of other inflammatory skin diseases, other than AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.\n2. Patients previously treated with abrocitinib or other oral\u002Fsystemic JAK inhibitors\n3. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.\n4. Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.",{"count":199,"type":22},150,"This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or intolerance) to ≤2 previous biologic therapies approved for M2S AD in the United States.\n\nThe aim of this study is to measure the effectiveness of abrocitinib in a real-world setting in patients with moderate-to-severe atopic dermatitis, with inadequate response or intolerance to ≤2 biologic therapies.",[32,202,203],"Atopic Dermatitis, Unspecified","Dermatitis, Atopic",[205],"Real world efficacy",{"date":184,"type":42},{"date":208,"type":42},"2026-04-24",{"date":210,"type":22},"2027-02-15",{"name":190,"class":76},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100578129","phase-3-a-long-term-study-of-the-medicine-called-abrocitinib-in-children-aged-2-years-and-older-with-moderate-to-severe-eczema-100578129","NCT06807281","A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema","A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria for the Extension Cohort:\n\n1\\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \\\u003C12 years old).\n\n• No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.\n\nInclusion Criteria for the De Novo Cohort:\n\nAge\n\n1. Children aged 6 to \\\u003C12 years at the time of informed consent\u002Fassent.\n\n   • No contraception methods are required for male participants.\n\n   Disease Characteristics:\n2. Participants who meet all of the following AD criteria:\n\n   * A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and\n   * A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and\n   * Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy.\n\n   Other Inclusion Criteria:\n3. Body weight ≥15 kg\n\nExclusion Criteria for the Extension Cohort:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n\n   Prior\u002FConcomitant Therapy:\n2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.\n3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.\n\n   Diagnostic Assessments:\n4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.\n5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.\n\nExclusion Criteria for the De Novo Cohort\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n2. Have any of the following medical conditions:\n\n   * Infections:\n\n     * Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (baseline) or have superficial skin infections within 1 week of Day 1.\n     * History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.\n     * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.\n     * Infection with HIV, hepatitis B, and\u002For hepatitis C\n     * Evidence of active TB or inadequately treated latent TB.\n   * Skin Conditions:\n\n     \\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.\n   * Other Conditions:\n\n     * Documented history of skeletal dysplasia.\n     * Documented history of retinal detachment.\n     * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.\n     * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.\n     * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.\n     * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.\n\n   Prior\u002FConcomitant Therapy:\n3. Prior treatment with a systemic JAK inhibitor for AD.\n4. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.\n5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.\n\n   Diagnostic Assessments:\n7. Hepatic and\u002For renal and\u002For hematological abnormalities defined as:\n\n   * AST \\>2 x ULN\n   * Hemoglobin \\\u003C10 g\u002FdL\n   * ALT \\>2 x ULN\n   * ANC \\\u003C1000\u002Fmm3\n   * Total bilirubin ≥1.5 x ULN\n   * ALC \\\u003C500\u002Fmm3\n   * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2\n   * Platelets \\\u003C150,000 \u002Fmm3\n\n   Other Exclusion Criteria:\n8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","11 Years",{"count":221,"type":22},500,[223],"PHASE3","This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.",[32],[227,228],"eczema","atopic dermatitis",{"date":184,"type":42},{"date":231,"type":42},"2025-12-02",{"date":233,"type":22},"2032-02-22",{"name":190,"class":76},38,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":77},"100614289","phase-2-a-dose-ranging-study-to-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-galvokimig-in-adult-study-participants-with-atopic-dermatitis-100614289","NCT07277660","A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis","Inclusion Criteria:\n\n* Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent\n* Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form \\[ICF\\]) and with:\n\n  1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline\n  2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline\n  3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline\n  4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline\n  5. Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy\n\nExclusion Criteria:\n\n* Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study\n* Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis\n* Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)\n* History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator\n* Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria\n* Previous treatment with galvokimig\n* Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment\n* All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline\n* Treatment with biologic agents must discontinued at least 3 months prior to baseline",{"count":244,"type":22},160,[62],"The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).",[32],[32,249,250],"Galvokimig,","UCB9741","2026-08-13",{"date":182,"type":42},{"date":254,"type":42},"2025-12-29",{"date":256,"type":22},"2028-03-06",{"name":258,"class":76},"UCB Biopharma SRL",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":146,"sex":17,"minAge":58,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100578221","phase-1-a-study-of-bbt001-in-healthy-volunteers-hvs-and-in-adult-patients-with-atopic-dermatitis-ad-100578221","NCT06808477","A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD)","A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and Adult Patients With AD","Key Inclusion Criteria\n\n1. Negative pregnancy tests for women of childbearing potential.\n2. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.\n3. Non-smokers, healthy current smokers (≤5 cigarettes\u002Fday), or ex-smokers.\n4. Adequate contraception use (for men and women of childbearing potential).\n\nKey Inclusion Criteria (Parts A, B, and D)\n\n1. Age of 18-65 years.\n2. Body mass index of 18 to 32 kg\u002Fm², weight capped at 120 kg.\n3. No clinically significant abnormalities or history of relevant diseases.\n\nKey Inclusion Criteria (Parts C and E only)\n\n1. Age of 18-72 years.\n2. Body mass index ≥16 kg\u002Fm², weight capped at 125 kg.\n3. Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.\n4. Moderate to severe atopic dermatitis\n5. Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3\n6. Atopic lesions cover ≥10% of body surface area (BSA)\n7. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.\n\nKey Exclusion Criteria\n\n1. Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.\n2. History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.\n3. Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.\n4. Positive drug\u002Falcohol tests or abnormal vital signs at screening or Day -1.\n5. Abnormal Electrocardiogram (ECG) findings\n6. History of drug\u002Falcohol abuse in the past 2 years.\n7. Donated \\>500mL blood within 2 months of screening.\n8. History of severe allergic reactions or hypersensitivity.\n\nKey Exclusion Criteria (Parts A, B, and D only)\n\n1\\. History of atopic dermatitis\n\nKey Exclusion Criteria (Parts C and E only)\n\n1. Skin diseases other than atopic dermatitis, significant tattoos, or scarring.\n2. Receipt of immunoglobulin or blood products within 30 days.\n3. Atopic dermatitis with ocular symptoms or chronic ocular steroid use.\n4. Chronic pruritus from conditions other than atopic dermatitis.\n5. Acute\u002Ftreated infections or chronic skin infections.\n6. Current use of sedating antihistamines or corticosteroids.","72 Years",{"count":268,"type":22},237,[25],"This is a Phase 1, randomized, blinded, placebo controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).",[32],"2026-08-12",{"date":251,"type":42},{"date":275,"type":42},"2025-02-27",{"date":277,"type":22},"2027-02-28",{"name":279,"class":76},"Bambusa Therapeutics",14,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":17,"minAge":147,"maxAge":85,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":290,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":50},"100523528","phase-2-cardamom-and-topical-roseomonas-in-atopic-dermatitis-100523528","NCT06096857","Cardamom and Topical Roseomonas in Atopic Dermatitis","A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=2 years\n2. Have a documented primary care provider near residence\n3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires)\n4. Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \\>=3 months before the screening visit\n\n   * Major Criteria: Must have \\>=3 basic features:\n\n     * Pruritus\n     * Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)\n     * Chronic or chronically relapsing dermatitis\n     * Personal or family history of atopy (asthma, allergic rhinitis, AD)\n   * Minor Criteria: Must have \\>=3 minor features:\n\n     * Xerosis\n     * Ichthyosis\u002Fpalmar hyperlinearity, keratosis pilaris\n     * Immediate (type 1) skin-test reactivity\n     * Raised serum IgE\n     * Early age of onset\n     * Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity\n     * Tendency toward non-specific hand or foot dermatitis\n     * Nipple eczema\n     * Cheilitis\n     * Recurrent conjunctivitis\n     * Dennie-Morgan infraorbital fold\n     * Keratoconus\n     * Anterior subcapsular cataracts\n     * Orbital darkening\n     * Facial pallor, facial erythema\n     * Pityriasis alba\n     * Anterior neck folds\n     * Itch when sweating\n     * Intolerance to wool and lipid solvents\n     * Perifollicular accentuation\n     * Food intolerance\n     * Course influenced by environmental or emotional factors\n     * White dermographism, delayed blanch\n5. EASI \\>5 and\u002For an IGA \\>=1 at time of enrollment.\n6. Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and\u002For tubal ligation) or menopausal (age \\>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device.\n7. Participants and parents\u002Flegal guardians (for minor participants) are willing and able to comply with all study visits and\u002For study-related procedures.\n8. Participants\u002Fparents\u002Fguardians must have the ability to provide informed consent\u002Fassent as applicable.\n9. Willingness to perform visits virtually.\n\nEXCLUSION CRITERIA:\n\n1. Previous treatment of AD:\n\n   * Within 4 weeks prior to the baseline visit with any of the following:\n\n     * Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine\n     * Phototherapy or photochemotherapy for AD\n   * Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:\n\n     * Topical steroids or topical calcineurin inhibitors\n     * Janus kinase (JAK) inhibitors (oral or topical)\n     * Dupilumab or any other biologic agent\n     * Topical PDE4 inhibitor\n     * Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.\n     * Bleach baths\n2. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.\n3. Superficial skin infection requiring topical treatment within 1 week of baseline visit.\n4. Known or suspected history of immunosuppression or immunodeficiency.\n5. Existence of indwelling central line.\n6. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.\n7. Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.\n8. Self-reported pregnancy or breastfeeding.\n9. Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly will not be excluded.",{"count":289,"type":22},120,[62],"Background:\n\nAtopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD.\n\nObjective:\n\nTo test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD.\n\nEligibility:\n\nPeople aged 2 years and older with AD.\n\nDesign:\n\nAll study visits will be remote. Participants will have 5 visits over about 7 months.\n\nParticipants will be screened. Researchers will review their AD and medical history.\n\nParticipants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks.\n\nHalf of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have.\n\nDuring 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers.\n\nParticipants may opt to have pictures taken of their AD.\n\nParticipants will fill out 4 online questionnaires.",[32,94],[94,32,294,295,296,297],"Roseomonas","Cardamom","Itch","Rash",{"date":251,"type":42},{"date":300,"type":42},"2024-10-09",{"date":302,"type":22},"2027-01-01",{"name":48,"class":49},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100637567","phase-2-a-phase-2b-study-of-the-effects-of-camoteskimab-in-adults-with-moderate-to-severe-atopic-dermatitis-100637567","NCT07599813","A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Age 18-65 inclusive, at the time of signing the informed consent.\n2. Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.\n3. Participants with moderate-to-severe AD defined by:\n\n   1. Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline.\n   2. AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.\n   3. EASI score of ≥ 16 at Screening and at Baseline.\n   4. Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.\n4. Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.\n5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n6. Participant provides signed informed consent\n\nExclusion Criteria:\n\n1. History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.\n2. Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.\n3. Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.\n4. Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.\n5. Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.\n6. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.\n7. Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.\n8. Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.\n9. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.\n10. Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).\n11. Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.\n12. Evidence of active or latent tuberculosis.\n13. Receipt of live or attenuated live vaccine within 6 weeks prior to screening.\n14. Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.\n15. Participant is known to have immune deficiency or is immunocompromised\n16. Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of:\n\n    * Completely resected basal cell or squamous cell carcinoma of the skin.\n    * Carcinoma in situ of the cervix.\n17. Has had previous exposure to anti-IL-18 therapy.\n18. Known allergy\u002Fsensitivity to any component of IMP.\n19. History of use of any of these medications as follows:\n\n    1. Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.\n    2. Systemic JAKi within 4 weeks prior to Baseline.\n    3. Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths.\n    4. Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral\u002Finjectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed.\n    5. Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening.\n    6. Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.\n    7. UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.\n    8. PUVA treatment within 4 weeks prior to Baseline\n    9. Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline\n    10. Topical products containing urea within 1 week prior to Baseline\n    11. Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline\n    12. Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.\n20. Female participant who is pregnant or breastfeeding or trying to conceive.\n21. Participant considered unlikely to adhere to treatment and\u002For follow the protocol in the opinion of the Investigator.","65 Years",{"count":313,"type":22},280,[62],"This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.",[32,317,93,203,318,94,319,180],"Atopic","Dermatologic Disease","Eczema Atopic Dermatitis","2026-08-11",{"date":272,"type":42},{"date":323,"type":42},"2026-05-28",{"date":325,"type":22},"2028-04-30",{"name":327,"class":76},"Apollo Therapeutics Ltd",85,{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":50},"100636048","phase-4-obtaining-descriptive-classifications-of-pruritus-and-assessing-change-in-pruritus-over-time-in-atopic-dermatitis-patients-using-topical-roflumilast-cream-100636048","NCT07560618","Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.","A Phase 4, Open Label Study to Assess Descriptive Classification of Pruritus Over Time With Roflumilast 0.15% Cream in Patients With Atopic Dermatitis","Inclusion Criteria:\n\n1. Male or female subjects aged 12 years or older\n2. Participants and\u002For legal guardians are legally competent to sign and give informed consent.\n3. Clinically confirmed diagnosis of active mild to moderate AD according to Hanifin and Rajka criteria (1980).\n4. History of AD for at least 6 months as determined by the Investigator using information from the subject's medical chart, from the subject's physician, or through subject\u002Fcaregiver interview. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening\n5. At least 3 months of chronic pruritus related to AD before the screening visit.\n6. EASI Score ≥5 at Baseline. EASI is evaluated for the entire body except the scalp, palms, and soles.\n7. vIGA-AD score of 'Mild' (2') or 'Moderate' (3') at Baseline. The vIGA-AD is evaluated for the entire body except the scalp, palms, and soles.\n8. Has AD involvement of ≥3% BSA (excluding the scalp, palms, soles) at Baseline.\n9. Participants must have access to a device and be willing to download the ExpiWell app and able to complete the associated questionnaires once daily at approximately the same time each day throughout participation in the study.\n10. Prior to the first application of study drug, participant has a baseline WI-NRS (24-hour recall period) and mItch-NRS score ≥ 4.0.\n11. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline\u002FDay 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable if this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.\n12. Females of non-childbearing potential should be post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status should be confirmed with FSH testing) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).\n13. In good health as judged by the Investigator, based on medical history, targeted physical examination, and vital signs. Subjects and parent(s)\u002Flegal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.\n\nExclusion Criteria:\n\n1. Subjects with any medical condition or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.\n2. Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.\n3. Participant had significant flares or unstable course in AD (i.e., condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.\n4. Participant has significant active systemic or localized infection, like clinically infected AD, or has used antibiotics (systemic or topical), antifungal or antiviral agents within 2 weeks prior to the run-in period.\n5. Participant with a history or presence of a condition that, in the opinion of the investigator, would interfere with the study assessments (e.g., generalized erythroderma, Netherton syndrome, psoriasis, or any skin condition other than AD that may risk inducing a pruritus flare\u002Fworsening).\n6. Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline\u002FDay 1 and during the study.\n7. Participants have tattoos, scratches, open sores, excessive hair, or skin damage that, in the opinion of the investigator, may interfere with study evaluations.\n8. Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.\n9. Known allergies to roflumilast or to the excipients in Roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).\n10. Participant has a clearly defined etiology for pruritus other than AD, including but not limited to urticaria, psoriasis, or other nonatopic dermatologic conditions; hepatic or renal disease; psychogenic pruritus; drug reaction; uncontrolled hyperthyroidism; and infection.\n11. Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline\u002F Day 1.\n12. History of severe depression, suicidal ideation or behavior at Baseline\u002FScreening indicative of suicidal ideation or behavior, whether lifetime or recent\u002Fcurrent.\n13. Subjects currently undergoing allergy testing (eg, food allergy testing or skin prick testing), patch testing, food challenges, or allergy desensitization, or plan to do so during the study.\n14. Subjects with any serious medical condition (eg, uncontrolled hypo- or hyper-thyroidism) or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.\n15. Previous treatment with Roflumilast cream or foam (any potency) or current Roflumilast use for any indication at the baseline visit that would be expected to continue during the trial.\n16. Subjects with a history of major surgery within 4 weeks prior to Baseline\u002FDay 1 or subjects who have major surgery planned during the study.\n17. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.\n18. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.\n19. Subjects with known or suspected severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C) as determined by the clinical investigator based upon subject's medical history and physical exam.",{"count":337,"type":22},40,[339],"PHASE4","This study is being done to obtain descriptive classifications of pruritus using a patient directed survey system and assess change in pruritus over time in patients with Atopic Dermatitis over 4 weeks with use of topical Roflumilast cream 0.15% QD.",[342,32],"ITCH",[94,296,344,32,345],"Pruritus","Topical",{"date":251,"type":42},{"date":348,"type":42},"2026-07-21",{"date":350,"type":22},"2027-08",{"name":352,"class":76},"Integrative Skin Science and Research",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100530882","a-study-to-observe-how-adolescent-patients-with-severe-atopic-dermatitis-despite-less-extensive-skin-lesions-eczema-area-and-severity-index-score--16-respond-to-dupilumab-treatment-100530882","NCT06192563","A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment","A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score \u003C 16 for Adolescents and \u003C 21 for Children) Receiving Dupilumab","AD-BEASCUITS","Inclusion Criteria:\n\n* Male or female, aged between 6 months and 17 years at the baseline visit.\n* Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:\n\n  \\-- Adolescents (12 to 17 years old) with EASI \\\u003C 16 and children (6 months to 11 years of age) with EASI \\\u003C 21 and.\n  1. Children's Dermatology Life Quality Index (cDLQI)\\* ≥ 10 and \u002F or\n  2. Itch NRS ≥ 7 and \u002F or\n  3. Localization in visible or sensitive areas (head\u002Fneck\u002Fhands or genitals)\n* Participants\u002F caregivers able to understand and complete study-related questionnaires.\n* Provided signed informed consent or parental\u002Flegally acceptable representative consent and participant assent where applicable.\n\n  * Only for adolescents and children 6-11 years of age.\n\nExclusion Criteria:\n\n* Use of dupilumab within 6 months prior to study entry.\n* Participants currently participating in any interventional clinical trial that modifies patient care.\n* Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","6 Months","17 Years",{"count":364,"type":22},230,"In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive\u002Fvisible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and\u002For localized AD to better understand the potential clinical benefits of dupilumab in these populations.\n\nThe main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \\\u003C 16 for adolescents (age 12-17 years) and \\\u003C 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.",[32],{"date":251,"type":42},{"date":369,"type":42},"2023-11-30",{"date":371,"type":22},"2028-03-31",{"name":373,"class":76},"Sanofi",9,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100651747","phase-3-a-study-to-learn-about-the-study-medicine-called-tilrekimig-in-people-with-moderate-to-severe-eczema-100651747","NCT07765888","A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema","A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED PHASE 3 COMBINATION THERAPY STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE OR OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS","Inclusion Criteria:\n\n* Participants 12 years of age or older\n* Must meet the following AD criteria:\n\n  1. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1\n  2. An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines\n  3. Moderate-to-severe eczema for at least 1 year\n* Adolescent participants must be up to date on immunizations per local guidance.\n\nExclusion Criteria:\n\n* Clinically Significant Autoimmune Disease\n* Significant Infection History or Active Infection\n* Known or Suspected Immunodeficiency\u002FImmunosuppression\n* Significant psychiatric illness or suicidality\n* Clinically significant hepatic, renal, or hematologic abnormalities",{"count":383,"type":22},375,[223],"The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body when used together with medicated creams or ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated.\n\n* This study is seeking participants who: Are aged 12 years or older.\n* Were confirmed to have atopic dermatitis (AD) at least 12 months ago.\n* Are not having an effective treatment result from medicines that are applied on skin for AD.\n* Are considered by their doctors to have moderate to severe AD.\n\nParticipants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20.\n\nSome participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last study treatment dose.",[32],[227,228,388,389,93,390,391],"Immune system diseases","skin diseases, genetic","Skin Diseases, Eczematous","skin diseases","NOT_YET_RECRUITING","2026-08-10",{"date":182,"type":42},{"date":182,"type":22},{"date":397,"type":22},"2028-05-23",{"name":190,"class":76},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":4},"100651611","phase-3-randomized-double-blind-placebo-controlled-study-of-nemolizumab-in-chinese-subjects-with-moderate-to-severe-atopic-dermatitis-100651611","NCT07762833","Randomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis","A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Chinese Subjects With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\n1. Chinese subjects aged ≥ 12 years at the screening visit.\n2. Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014, Appendix 1) at the time of the screening visit.\n3. EASI score ≥ 16 at both the screening and baseline visits.\n4. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.\n5. AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits.\n6. Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit:\n\n   * Screening PP-NRS score will be determined by a single PP-NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.\n   * Baseline PP-NRS score will be determined based on the average of daily PP-NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation.\n7. Documented history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI). Acceptable documentation includes patient records with information on TCS (with or without TCI) prescription and treatment outcome, or written documentation of the conversation with the subject's treating physician, if different than the investigator.\n\n   Inadequate response to TCS treatments (with or without TCI) is defined as:\n   1. Failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) despite treatment with a regimen of a medium- or high-potency TCS\\* (with or without TCI), applied for at least 4 weeks or for the maximum duration per prescribing information; or\n   2. Requirement of a long-term treatment (\\> 4 weeks) with a high-potency TCS\\* (with or without TCI) to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2); Note: If subjects had received a TCI in addition to a TCS, documentation on failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) is also required.\n\n   or c. If documentation of inadequate response to topical treatments is not available, subjects with a documented recent course of systemic treatment or phototherapy for AD (within 6 months before the visit) will also be considered as inadequate responders to topical treatments.\n\n   If documentation is inadequate, subjects may be rescreened after such documentation is obtained.\n\n   \\* Refer to Appendix 2 for a listing of permitted medium and high-potency TCS medications that are commercially available in China.\n8. Agree to apply an authorized TCS ± TCI from the screening visit and throughout the study as determined appropriate by the investigator.\n9. Women of childbearing potential (WOCBP) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last IP injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last IP injection. This criterion also applies to a prepubertal female subject who begins menses during the study. Adequate and approved methods of contraception applicable for the subject and\u002For her partner are defined below:\n\n   * Progestogen-only oral hormonal contraception\n   * Combination of male condom with cap, diaphragm, or sponge with spermicide\n   * Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception (double barrier methods)\n   * Injectable or implanted hormonal contraception\n   * Intrauterine devices\n   * Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study\n   * Vasectomy of partner at least 3 months before the study W Emergency contraception to prevent pregnancy after unprotected intercourse are not acceptable methods for routine use.\n10. Female subjects of non-childbearing potential must meet one of the following criteria:\n\n    * Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range.\n    * Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study Note: Bilateral tubal ligation is not accepted as a reason for non-childbearing potential.\n11. Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.\n12. Understand and sign an informed consent form\u002Fassent form before any investigational procedure(s) are performed\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 30 kg.\n2. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.\n3. Known or suspected history of immunosuppression, or unusually frequent, recurrent, severe, or prolonged infections, as per investigator's judgment.\n4. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.\n5. Presence of confounding skin condition that may interfere with study assessments (e.g. Netherton syndrome, psoriasis, cutaneous T-cell lymphoma \\[mycosis fungoides or Sezary syndrome\\], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).\n6. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.\n7. Any medical (e.g., serious cardiac\u002Fhepatic\u002Flung \\[including uncontrolled asthma\\]\u002Fhematologic disease) or psychological condition or any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (\\> 3 × upper limit of normal \\[ULN\\]) in combination with elevated bilirubin (\\> 2 × ULN), during the screening period that may put the subject at significant risk according to the investigator's judgment, if he\u002Fshe participates in the clinical study, or may interfere with study assessments (e.g. poor venous access or needle-phobia).\n8. Planned or expected major surgical procedure during the clinical study.\n9. Having received any of the following treatments within the specified timeframe before the baseline visit:\n\n   Treatment(s) Timeframe Coal tar products 2 weeks Topical PDE-4 inhibitor 2 weeks Non-authorized TCS 2 weeks Topical medications, including authorized TCS\u002FTCI, with occlusive dressings (e.g., wet wraps) 2 weeks Systemic corticosteroids (corticosteroid inhalers and intraocular corticosteroids are permitted) 4 weeks Phototherapy or tanning beds 4 weeks Immunosuppressive or immunomodulatory drugs (e.g., cyclosporin A, oral tacrolimus, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors) 4 weeks or 5 half-lives (whichever is longer) Biologics and their biosimilars (e.g., etanercept, adalimumab, infliximab, omalizumab) 8 weeks or 5 half-lives (whichever is longer) Dupilumab 10 weeks Live-attenuated vaccines 4 weeks Drugs with a sedative effect such as benzodiazepines, imidazopyridines, barbiturates, sedative antidepressants (e.g., amitriptyline), SSRIs (e.g., paroxetine), or SNRIs, except if these treatments were taken at a stable dose for at least 3 months before screening (Stable treatment with antihistamines with sedative effect is allowed.) 1 week Gabapentinoids (e.g., gabapentin, pregabalin) 4 weeks Cannabinoids 2 weeks Cannabinoids alternative medicine for AD (e.g., traditional Chinese medicine) 2 weeks Aromatic Hydrocarbon Receptor \\[AhR\\] modulator (e.g. tapinarof ) 2 weeks\n\n   Abbreviations: AD = atopic dermatitis; PDE-4 = phosphodiesterase-4; SNRI = serotonin-norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; TCI = topical calcineurin inhibitor; TCS = topical corticosteroid.\n\n   Note: Subjects should not interrupt ongoing treatment with medications important for the subject's health for the sole purpose of participating in this study.\n10. Subjects unwilling to refrain from using prohibited medications during the clinical study.\n11. Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period.\n12. Previous treatment with nemolizumab.\n13. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the IP excipients.\n14. History of intolerance to low- or medium-potency TCS or for whom TCS is not advisable (e.g., hypersensitivity, significant skin atrophy).\n15. Currently participating or participated in any other study of an investigational drug or device, within the past 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) before the screening visit.",{"count":407,"type":22},240,[223],"This is a bridging study only for Chinese subjects. The goal of this clinical trial is to learn if drug Nemolizumab works to treat moderate to severe AD in over 12 years old male and female. It will also learn about the safety of drug Nemolizumab.\n\nResearchers will compare drug Nemolizumab to a placebo (a look-alike substance that contains no drug) to see if drug Nemolizumab works to treat moderate to severe atopic dermatitis.\n\nParticipants will:\n\nTake drug Nemolizumab or a placebo at baseline and every 4 weeks followed, Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the disease situation.",[32],[412],"Moderate-to-Severe Atopic Dermatitis",{"date":251,"type":42},{"date":415,"type":22},"2026-09-28",{"date":417,"type":22},"2028-09-28",{"name":419,"class":76},"Galderma R&D",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100595857","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-img-007-in-adult-participants-with-moderate-to-severe-atopic-dermatitis-100595857","NCT07037901","A Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","ADAPTIVE","Key Inclusion Criteria:\n\n* Moderate-to-severe AD\n* Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable\n* Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception\n* Male participants must agree to use a highly effective method of contraception\n* EASI score ≥16\n* vIGA-AD score ≥3\n* ≥10% body surface area (BSA) of AD involvement\n* Mean peak pruritus numerical rating scale ≥ 4 during 7-days before randomization\n\nKey Exclusion Criteria:\n\n* Positive hepatitis B, hepatitis C, or human immunodeficiency virus infection\n* Evidence of active or latent tuberculosis (TB)\n* History of untreated or inadequately treated TB infection\n* Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals\n* Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement\n* Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study\n* Having received any of the specified therapies within the specified timeframe(s) prior to the Baseline visit","74 Years",{"count":430,"type":22},405,[62],"The purpose of this study is to evaluate the efficacy and safety of different dose regimens of IMG-007, compared to placebo.",[32,434,94],"Atopic Dermatitis Eczema",[436,32,203,93,94,437,438,439],"IMG-007","Skin Diseases","Immune System Diseases","Dermatologic Agents",{"date":272,"type":42},{"date":442,"type":42},"2025-06-17",{"date":444,"type":22},"2028-08",{"name":446,"class":76},"Inmagene LLC",30,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":146,"sex":17,"minAge":456,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":477},"100618573","retention-of-vernix-caseosa-in-newborns-for-primary-prevention-of-atopic-dermatitis-100618573","NCT07333378","Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis","Post-partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome.","PROTEGO","Inclusion Criteria:\n\n* pregnant mother aged 18 and older, who is able to provide informed consent for participation\n* delivery of a healthy, singleton newborn (vaginal or cesarean) at one of the study sites.\n* parents are able and willing to comply with the study schedule and procedures\n\nExclusion Criteria:\n\n* birthweight \\\u003C2000 g\n* prematurity younger than 34 weeks of gestation\n* multiple gestation \u002F multiple births\n* maternal HIV-positivity\n* clinical and\u002For laboratory diagnosis of chorioamnionitis.\n* need for neonatal hospitalization or presence of an acute illness (e.g., neonatal respiratory distress syndrome) within the first 24 hours of life.\n* severe and generalized congenital skin disorder (e.g., congenital ichthyosis).","0 Days",{"count":458,"type":22},1383,[460],"NA","Atopic dermatitis (AD), also known as eczema, is a common chronic inflammatory skin disease that usually begins in infancy and causes significant itching, discomfort, and sleep disturbance. It affects up to one in five children worldwide and represents a growing public-health problem. Research has shown that genetic and environmental factors contribute to its development, especially those related to skin-barrier integrity and the skin microbiome during early life. Preventing AD before it starts-known as primary prevention-has become an important goal.\n\nVernix caseosa is a naturally occurring, white, creamy substance that covers the skin of newborns at birth. It forms during the last trimester of pregnancy and plays a key role in protecting and hydrating the baby's skin before and after birth. Vernix contains water, lipids, and proteins with antimicrobial and anti-inflammatory properties. Despite these potential benefits, in many hospitals vernix is routinely removed soon after delivery as part of standard newborn cleaning or bathing practices. However, there is little scientific evidence to support early removal, and some studies suggest that keeping vernix on the skin for longer may help the newborn's skin barrier function and reduce colonization by harmful bacteria.\n\nThe PROTEGO Study (Post-Partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome) is a randomized controlled clinical trial designed to test whether delaying the removal of vernix caseosa after birth can help prevent atopic dermatitis and improve skin health during the first year of life.\n\nA total of 1,383 mother-infant pairs will be enrolled from three maternity hospitals in Santiago, Chile. Participants will be randomly assigned to one of two groups:\n\n1. Retention group: Vernix caseosa will be left on the skin and allowed to dry naturally; the baby's first bath will be delayed according to the study protocol.\n2. Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth.\n\nAll infants will be followed for 12 months with regular clinical assessments, standardized skin evaluations, and collection of biological samples. The main outcome will be the cumulative incidence of atopic dermatitis, diagnosed using modified UK Working Party criteria and\u002For Hanifin \\& Rajka criteria at 12 months of age. Secondary outcomes include skin-barrier measurements (transepidermal water loss, skin pH, and natural moisturizing factor), the composition of the skin microbiome, and early signs of allergic or infectious diseases.\n\nThis study will provide high-quality evidence on whether preserving vernix caseosa after birth is a simple, safe, cost-effective and natural strategy to strengthen the newborn's skin barrier and reduce the risk of eczema and related conditions. The results could help improve newborn-care practices and promote skin health in early life worldwide.",[32],[464,465,466,227,228,467,468],"vernix caseosa","primary prevention","newborn","skin infections","Staphylococcus aureus","2026-08-08",{"date":320,"type":42},{"date":472,"type":22},"2026-09-01",{"date":371,"type":22},{"name":475,"class":476},"Pontificia Universidad Catolica de Chile","OTHER",2,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":362,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":500,"locationsCount":477},"100650475","digital-mindfulness-meditation-in-adolescents-with-atopic-dermatitis-100650475","NCT07746427","Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis","Outcomes of a Digital Mindfulness Meditation App-Based Intervention in Adolescents With Moderate to Severe Atopic Dermatitis (MIND-AD)","MIND-AD","Inclusion Criteria\n\n* Adolescents age 12-17 years.\n* Atopic dermatitis refractory to standard topical treatment including topical steroids or topical calcineurin inhibitors.\n* Moderate to severe atopic dermatitis via PO-SCORAD score on enrollment.\n\nExclusion Criteria\n\n* Started on a biologic agent (i.e. dupxient) within the past 3 months.\n* Mild atopic dermatitis via PO-SCORAD score on enrollment.",{"count":337,"type":22},[460],"Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients. The investigators hypothesize that regular use of a digital mindfulness meditation app will improve disease control and quality of life in adolescents with moderate to severe atopic dermatitis based on validated survey measures.",[32,94],[491,492,493],"Meditation","mindfulness","digital health","2026-08-06",{"date":496,"type":42},"2026-08-07",{"date":161,"type":22},{"date":499,"type":22},"2028-07",{"name":501,"class":476},"Weill Medical College of Cornell University",{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":509,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":50},"100650986","a-study-to-evaluate-the-equivalence-of-ibi3027-and-dupilumab-injection-in-participants-with-moderate-to-severe-atopic-dermatitis-100650986","NCT07754786","A Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","A Multicenter, Randomized, Double-blind, Parallel, and Positive-controlled Phase III Clinical Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","Key inclusion criteria:\n\n1. Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;\n2. Male or female participants aged 18 to 75;\n3. AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;\n4. Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;\n5. Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;\n6. As assessed by investigator, records indicating poor treatment response with topical local medications, or not suitable for topical treatment due to other medical reasons (such as severe adverse reactions or safety risks, etc.), within 6 months prior to the screening\n\nKey exclusion criteria：\n\n1. Have active skin diseases that may affect the assessment of AD (such as psoriasis or lupus erythematosus), or other skin complications caused by other diseases. Those who are in an acute exacerbation state of AD at the time of randomization (such as participants having rapidly progressing erythroderma or a tendency towards erythroderma, as assessed by the investigators);\n2. Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;\n3. Suspected immunosuppressive disease within 6 months prior to screen;\n4. Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);\n5. Participants at high risk of infection;\n6. Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;\n7. Positive for human immunodeficiency virus (HIV) antibody;\n8. Participants with syphilis infection;\n9. Positive for the hepatitis C virus (HCV) antibody and HCV RNA (if HCV antibody positive);\n10. Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA (if HBsAg positive);\n11. Previous use IL-4 and\u002For IL-13 targeting drugs (such as dupilumab, etc.) for the treatment of AD with no response or poor efficacy;\n12. Systemic use of IL-4Rα or IL-13 antibody treatment ≤ 3 months or 5 half-lives (if the half-life is known) prior to randomization;\n13. ≥ 2 bleach baths ≤ 2 weeks prior to randomization;\n14. Use of drugs containing main active ingredients such as compound glycyrrhizin or total polysaccharides of peony ≤ 2 weeks prior to randomization;\n15. Following treatments ≤4 weeks prior to randomization: a. systemic use of glucocorticoids or immunosuppressants; b. systemic use of traditional Chinese medicine; c. calcium channel-based anti-epileptic drugs, anti-serotonin agents, and opioid receptor antagonists, with antipruritic effects; d. ultraviolet therapy.\n16. Treatment of allergen-specific immunotherapy ≤ 6 months prior to randomization;\n17. Use of any cell depletion agents including but not limited to rituximab ≤12 months prior to randomization.","75 Years",{"count":511,"type":22},520,[223],"This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.\n\nStudy period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).\n\nAfter screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.",[32],"2026-08-05",{"date":393,"type":42},{"date":518,"type":22},"2026-10-20",{"date":520,"type":22},"2028-08-26",{"name":522,"class":76},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":146,"sex":17,"minAge":58,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100650380","phase-1-a-study-of-byn-001-in-healthy-adults-and-in-adults-with-moderate-to-severe-atopic-dermatitis-100650380","NCT07746817","A Study of BYN-001 in Healthy Adults and in Adults With Moderate to Severe Atopic Dermatitis","A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BYN-001 in Healthy Adult Participants and Participants With Moderate to Severe Atopic Dermatitis","BYN-001-101","Part A and B Key Inclusion Criteria:\n\n* Age 18-55 years of age\n* Must be in good health with no significant medical conditions\n* Willing and able to attend all study visits and comply with study requirements\n* Able and willing to provide written informed consent\n\nPart A and B Exclusion Criteria:\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychosocial condition that prohibits study completion\n* Know history of illicit drug use or abuse, alcoholism and\u002For smoking more than -5 cigarettes a day in the prior 3 months\n* History of sever allergic reactions of hypersensitivity\n\nPart C Inclusion Criteria\n\n* Age 18-55 years of age\n* Must be in good health with no significant medical conditions\n* Willing and able to attend all study visits and comply with study requirements\n* Able and willing to provide written informed consent\n* Documented chromic atopic dermatitis within 1 year prior to screening\n* Moderate to severe atopic dermatitis\n\nPart C Key Exclusion Criteria\n\n* Evidence of clinically significant condition or disease\n* Any physical or psychosocial condition that prohibits study completion\n* Know history of illicit drug use or abuse, alcoholism and\u002For smoking more than 5 cigarettes a day in the prior 3 months\n* History of sever allergic reactions of hypersensitivity\n* Incomplete washout of prior atopic dermatitis medications\n* Other confounding skin diseases","55 Years",{"count":533,"type":22},56,[25],"This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.",[32,537],"Healthy Participants",[539,540,541,542,543,92,544],"IL-25","Monoclonal antibody","First-in-human","Multiple ascending dose","Single ascending dose","Healthy Participant",{"date":496,"type":42},{"date":547,"type":22},"2026-08-01",{"date":549,"type":22},"2028-12-31",{"name":551,"class":76},"Bionyra Pharma",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":570},"100615299","this-study-is-a-non-interventional-disease-registry-of-adolescent-and-adult-patients-with-atopic-dermatitis-who-initiate-or-switch-any-systemic-treatment-100615299","NCT07290803","This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment","Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments","ARMADA-AD","Inclusion Criteria:\n\n* Patients aged more than or equal to (≥) 12 years at the time of consent.\n* Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.\n* Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)\n* Signed informed consent for registry participation by the patient or parent\u002Flegal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.\n* Insufficient understanding of the study by the patient and\u002For parent\u002Fguardian.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":561,"type":22},1000,"The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.\n\nThe study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.",[32],{"date":494,"type":42},{"date":566,"type":42},"2025-11-17",{"date":568,"type":22},"2034-01-30",{"name":373,"class":76},79,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":146,"sex":17,"minAge":578,"maxAge":579,"enrollmentInfo":580,"targetDuration":4,"studyType":23,"phases":582,"briefSummary":583,"conditions":584,"keywords":586,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":50},"100651104","use-of-bifidobacterium-bifidum-in-formula-fed-infants-with-colic-with-or-without-atopic-dermatitis-100651104","NCT07754968","Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis","Efficacy of Bifidobacterium Bifidum on Symptoms of Infant Colic and Atopic Dermatitis: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* Non-breastfed infants aged ≤ 5 months diagnosed with infant colic according to Rome IV criteria, with or without atopic dermatitis.\n* Written informed consent from parents or legal guardians.\n\nExclusion Criteria:\n\n* Age \\> 5 months.\n* Exclusive breastfeeding or mixed feeding.\n* Absence of infant colic diagnosis.\n* Presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections, autoimmune diseases, IBD, celiac disease, genetic-metabolic disorders, cystic fibrosis or other chronic pulmonary diseases, cardiovascular\u002Frespiratory\u002FGI malformations, neuropsychiatric disorders, neurological conditions, or vegetarian\u002Fvegan diet.","1 Week","5 Months",{"count":581,"type":22},64,[460],"The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant colic (according to Rome IV criteria), with or without concomitant atopic dermatitis.\n\nThe main questions it aims to answer are:\n\n* Does daily administration of B. bifidum for 8 weeks achieve at least a 50% reduction in average daily crying duration compared to placebo?\n* Does B. bifidum supplementation improve secondary outcomes, including crying frequency, sleep quality, bowel movement frequency, stool consistency, fecal microbiota composition, short-chain fatty acid (SCFA) levels, and SCORAD score in infants with atopic dermatitis? Researchers will compare formula-fed infants receiving Bifipral® drops (containing B. bifidum strains BFP19® and BFP29®) to a comparison group receiving an indistinguishable placebo to see if the probiotic safely improves colic symptoms and gut microbiota balance.\n\nParticipants will be asked to:\n\n* Complete a 7-day observational run-in period to confirm eligibility and record baseline symptoms in a daily diary.\n* Administer 5 drops daily of the study product (probiotic or placebo) for 8 weeks.\n* Complete daily diaries tracking crying duration\u002Ffrequency, sleep parameters, and bowel habits.\n* Attend 3 clinical visits (Baseline, Week 8, and a Safety Follow-up 2-4 weeks post-treatment).\n* Provide fecal samples at Baseline (Visit 1) and Week 8 (Visit 2) for microbiota profiling and SCFA analysis.",[585,32],"Infant Colic",[587,588,92,589,590,591],"Bifidobacterium bifidum","Infant colic","Probiotics","Gut microbiota","Randomized Controlled Trial","2026-08-04",{"date":393,"type":42},{"date":595,"type":42},"2026-07-01",{"date":597,"type":22},"2028-09-01",{"name":599,"class":476},"University of Roma La Sapienza",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":610,"conditions":611,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":374},"100642106","phase-2-a-phase-2b-dose-ranging-study-to-evaluate-the-efficacy-and-safety-of-env-294-in-adults-with-moderate-to-severe-atopic-dermatitis-100642106","NCT07643766","A Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of ENV-294 in Adult Participants With Moderate-to-Severe Atopic Dermatitis","Inclusion Criteria:\n\nIn order to participate in this study all participants must:\n\n1. Be at least 18 years of age at the time of signing the ICF.\n2. Have chronic AD (also known as atopic eczema) that was diagnosed at least 12 months prior to Screening.\n3. Have a history of inadequate response or intolerance to topical corticosteroids or other topical treatments for AD within 6 months before Screening and\u002For inadequate response to a systemic therapy within 12 months before Screening.\n4. Have moderate-to-severe AD, at Screening and Baseline, as defined by the following criteria:\n\n   1. A vIGA score of 3 (moderate) or 4 (severe)\n   2. EASI score of ≥16\n   3. Body surface area involvement of ≥10%\n5. Have PP-NRS score ≥4 Screening and Baseline - the baseline score refers to a weekly average.\n6. Use a bland emollient daily for at least 1 week prior to Day 1 and agree to continue using that same emollient daily at the same frequency (minimally, once daily) throughout the study.\n7. Participants of reproductive potential (male and female participants) must practice effective methods of contraception as per protocol.\n\nExclusion Criteria:\n\nParticipants are excluded if they:\n\n1. Have any clinically significant medical condition or physical\u002Flaboratory\u002FECG\u002Fvital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results.\n2. Have clinically significant abnormalities in any of the clinical laboratory evaluations at Screening or Baseline as determined by the Investigator.\n3. Have the presence of any concomitant skin conditions (eg, psoriasis, seborrheic dermatitis) or have large tattoos that would interfere with clinical assessment, evaluation of AD, or treatment response as determined by the investigator.\n4. Have an ongoing clinically significant skin infection or is receiving treatment for infection that may interfere with assessment of AD as determined by the investigator.\n5. Are pregnant or breastfeeding or are planning to become pregnant during the duration of the study and for 90 days after the last administration of study drug.\n6. Are taking or have taken any prespecified prohibited therapies within a specific timeframe as determined by the Investigator.",{"count":608,"type":22},200,[62],"This double-blind, placebo-controlled study is designed to evaluate the safety and efficacy of ENV-294 in adults with moderate-to-severe atopic dermatitis (AD). The study will compare three dose levels of ENV-294 with placebo administered for 12 weeks. Participants will undergo screening, receive study treatment, and complete scheduled assessments of disease activity, symptoms, quality of life, safety, pharmacokinetics, and biomarker responses.",[32],{"date":494,"type":42},{"date":614,"type":42},"2026-06-29",{"date":616,"type":22},"2028-05",{"name":618,"class":76},"Enveda Therapeutics",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":146,"sex":17,"minAge":627,"maxAge":361,"enrollmentInfo":628,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":629,"conditions":630,"keywords":632,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":50},"100610544","cutaneous-biomarkers-in-atopic-eczema-using-a-non-invasive-micro-suction-device-in-babies-100610544","NCT07228962","Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies","Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies","CARE","Inclusion Criteria:\n\n1. Healthy babies and babies with atopic dermatitis up to 6 months old.\n2. Ability of parents\u002Fguardians\u002Fcaregivers to provide written informed consent for study participation.\n3. Willingness of parents\u002Fguardians\u002Fcaregivers to comply with all study requirements.\n4. Parents\u002Fguardians\u002Fcaregivers competent use of English language.\n\nExclusion Criteria:\n\n1. Parents\u002Fguardians\u002Fcaregivers unable to give informed consent.\n2. Preterm birth (defined as birth before 37 completed weeks gestation).\n3. Significant inflammatory skin disease at birth.\n4. Baby has any other serious health issue.","0 Months",{"count":447,"type":22},"This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments.\n\nSpecifically, it aims to:\n\n1. Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation).\n2. Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema.\n3. Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device.\n4. Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).",[94,32,631],"Atopic Eczema",[94,32,633,634,635,636,156,637],"Immune System","Skin Barrier","Dermatology","Interstitial Skin Fluid","Early life",{"date":515,"type":42},{"date":640,"type":42},"2026-03-31",{"date":642,"type":22},"2027-06-30",{"name":644,"class":476},"King's College London"]