[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Attovia Therapeutics Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100657140","phase-2-efficacy-and-safety-of-atto-1310-in-the-treatment-of-participants-with-chronic-pruritus-of-unknown-origin-100657140",false,"NCT07833306","Efficacy and Safety of ATTO-1310 in the Treatment of Participants With Chronic Pruritus of Unknown Origin","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ATTO-1310 for the Treatment of Participants With Chronic Pruritus of Unknown Origin","Inclusion Criteria:\n\n* Aged 18 to 90 years with a body weight of 50 to 125 kg and body mass index (BMI) between 18.5 and 40 kg\u002Fm\\^2.\n* History of chronic pruritus for at least 6 months that is considered of unknown origin (without a clear association to another condition or medication) as assessed by the Investigator.\n* Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.\n* History of inadequate control of pruritus with at least 1 antihistamine within 6 months of Screening.\n* Patient Global Impression of Severity (PGI-S) of pruritus of \"severe\" at Screening.\n* Use of a stable dose of topical bland emollient twice daily for at least 2 weeks immediately before Day 1\n* Weekly mean of daily WI-NRS ≥7 at Day 1\n* Negative pregnancy test\n\nExclusion Criteria:\n\n* Known condition, other than dry skin, that is considered by the Investigator to be the primary cause of chronic pruritus, including: Presence of a primary dermatologic condition associated with pruritic skin lesions, regional neuropathic pruritus with the exception of peripheral small fiber neuropathy, severe renal failure, hepatobiliary disease, recent infectious dermatoses, suspected somatoform pruritus, ongoing drug-induced pruritus, malignancy or hemopathy, uncontrolled endocrine disease,\n* Liver function tests (bilirubin, AST, ALT, alkaline phosphatase) \\>2.5 times above the upper limit of normal\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* History of malignancy within 5 years of Screening\n* History of severe or uncontrolled asthma\n* History of known primary immunodeficiency, is considered immunocompromised, or has been treated for a parasitic infection in the past 6 months.\n* History of attempted suicide within the past 2 years.\n* History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV.\n* Active or untreated latent tuberculosis (TB) infection.\n* Any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before Day 1.\n* History of drug or alcohol abuse within 1 year of Screening","ALL","18 Years","90 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to assess the efficacy and safety of ATTO-1310 in patients with chronic pruritus\u002Fitch of unknown origin.\n\nThe main questions it aims to answer are:\n\nDoes ATTO-1310 treatment alleviate symptoms of itch in participants with chronic pruritus\u002Fitch? What medical problems do participants have when taking ATTO-1310 for 24 weeks? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.",[27],"Chronic Pruritus of Unknown Origin",[29,30,31,32],"pruritus","CPUO","itch","itchy","NOT_YET_RECRUITING","2026-09-16",{"date":36,"type":37},"2026-09-22","ACTUAL",{"date":39,"type":21},"2026-12-21",{"date":41,"type":21},"2028-10-30",{"name":43,"class":44},"Attovia Therapeutics Inc","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100656092","phase-1-safety-tolerability-and-pk-of-atto-1091-in-healthy-adult-volunteers-and-patients-with-ulcerative-colitis-100656092","NCT07819799","Safety, Tolerability and PK of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis","A Phase 1, Multi-Part, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ATTO 1091 in Healthy Adult Volunteers and Patients With Ulcerative Colitis","Parts 1\\&2 (Healthy Volunteers) Key Inclusion Criteria:\n\n* Any sex or gender who is 18 to 60 years old, inclusive, at Screening.\n* Body weight of 45 to 125 kg, inclusive, and body mass index (BMI) between 18.5 and 35 kg\u002Fm2.\n* Considered in good general health based on medical history, physical exam, 12-lead ECG, screening clinical laboratory findings, and vital signs.\n* Meets contraception requirements\n* Negative pregnancy test for participants of childbearing potential.\n\nPart 3 (Participants with Ulcerative Colitis) Key Inclusion Criteria:\n\n* Any sex or gender who is 18 to 80 years old\n* Body weight of 45 to 125 kg and BMI between 17.0 and 40.0 kg\u002Fm2\n* UC diagnosis confirmed by endoscopy and histology ≥3 months prior to Screening\n* Moderately to severely active UC as defined by Modified Mayo Clinic Score (stool frequency, rectal bleeding, endoscopy) 5 to 9 inclusive, with Mayo endoscopic subscore ≥2 as confirmed by the central reader during Screening\n* Rectal bleeding subscore ≥1 and stool frequency subscore ≥1 at Screening.\n* Naïve to treatment with advanced therapies or has had an inadequate response, loss of response, or intolerance to no more than 3 drugs in 2 classes of the following:\n\n  * Tumor necrosis factor (TNF-α) antagonists\n  * Interleukin IL-12\u002FIL-23 antagonists\n  * Integrin inhibitors\n  * JAK antagonists\n  * S1P receptor agonists\n  * Novel class with biologic-like activity (e.g. TL1A antagonists)\n* Meets washout criteria for prior UC therapies as specified in the protocol.\n* Negative pregnancy test for participants of childbearing potential\n\nParts 1\\&2 (Healthy Volunteers) Key Exclusion Criteria\n\n* Any clinically significant underlying illness\n* History of malignancy within 5 years of Screening\n* History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study\n* History of uncontrolled asthma requiring systemic corticosteroids or hospitalization for asthma within 6 months prior to Day 1\n* History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or is positive for HIV\n* Active or latent tuberculosis infection\n* Smoking more than 20 cigarettes (or cigars, cigarillos, or e-cigarettes equivalent to approximately 40 mg nicotine) per day\n* History of drug or alcohol abuse\n* Laboratory values outside of the normal range considered clinically significant by the investigator\n\nPart 3 (Participants with Ulcerative Colitis) Key Exclusion Criteria:\n\n* Any clinically significant underlying illness\n* History of malignancy within 5 years of Screening\n* History of major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study\n* History of uncontrolled asthma requiring systemic corticosteroids or hospitalization for asthma within 6 months prior to Day 1\n* History of known primary immunodeficiency or is considered immunocompromised\n* Has been treated for a parasitic infection in the past 6 months\n* Participant has active HBV or HCV or is positive for HIV\n* Participant has active or latent TB\n* Stool positive for Clostridioides difficile toxin at Screening\n* Concomitant primary sclerosing cholangitis.\n* History of active major depressive episode or suicidal ideation\n* History of hypersensitivity (including anaphylaxis) to a biologic medication, vaccine, immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody), or to any of the IP excipients\n* Diagnosis of non-UC or confounding GI conditions including Crohn's disease, indeterminate colitis, microscopic colitis, ischemic or radiation colitis.\n* Disease limited to isolated ulcerative proctitis (\\\u003C15 cm).\n* Unresected colonic dysplasia or unresected adenomatous colonic polyps, fulminant colitis, toxic megacolon, bowel perforation, current colonic strictures, fistulae, stoma, ileostomy, colostomy, abdominal abscess, or anticipated need for colectomy during the study.\n* History of extensive colonic resection\n* History of drug or alcohol abuse\n* Laboratory values outside of the normal range considered clinically significant by the investigator",true,"65 Years",{"count":55,"type":21},96,[57],"PHASE1","The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics (PK) of ATTO-1091 in healthy adults and patients with ulcerative colitis.\n\nThe main questions it aims to answer are:\n\nWhat medical problems do participants have when taking ATTO-1091? How long does ATTO-1091 stay in the body after dosing? Researchers will compare ATTO-1091 to a placebo (a look-alike substance that contains no drug).\n\nParticipants will be dosed with ATTO-1091 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.",[60],"Ulcerative Colitis (UC)",[62,63,64],"ulcertive colitis","IBD","UC","2026-09-09",{"date":67,"type":37},"2026-09-15",{"date":69,"type":21},"2026-12-14",{"date":71,"type":21},"2028-07-15",{"name":43,"class":44},""]