[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-lupus-erythematosus":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,155,0,25,[9,44,65,93,119,147,171,197,219,246,268,290,319,352,380,405,428,458,480,507,529,553,573,599,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944",false,"NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[28,29,30],"Lupus","Systemic Lupus Erythematosus","Lupus Nephritis","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-05-25",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Hoffmann-La Roche","INDUSTRY",21,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100632540","phase-2-a-study-of-e6742-in-participants-with-systemic-lupus-erythematosus-100632540","NCT07515014","A Study of E6742 in Participants With Systemic Lupus Erythematosus","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Response Study to Evaluate the Efficacy and Safety of E6742 in Subjects With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Male or female adult, age \\>=18 years (the minimum age may be different from 18 years in certain countries based on regional requirements) and \\\u003C=75 years at the time of informed consent\n2. Diagnosed with SLE at least 6 months before the informed consent AND fulfill the 2019 EULAR\u002FACR classification criteria at Screening based on medical history\n3. At least BILAG-2004 category A in \\>=1 organ system or BILAG-2004 category B in \\>=2 organ systems at screening\n4. SLEDAI-2K score \\>=6 points at Screening AND Clinical SLEDAI-2K score \\>=4 points at Baseline\n5. Receiving at least one of the following treatments for SLE (if more than 1 treatment is used, all medications must be within the dosage defined in the protocol):\n\n   1. OCS (\\\u003C=30 mg\u002Fday, prednisone or equivalent): The dosing regimen should be stable for at least 4 weeks before the first dose of study drug.\n   2. Oral hydroxychloroquine (\\\u003C=400 mg\u002Fday), quinacrine (\\\u003C=200 mg\u002Fday): These medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose.\n   3. Immunosuppressants: The following medications should have been initiated or discontinued at least 12 weeks before the first dose of study drug, and the dosing regimen should remain stable for at least 8 weeks before the first dose\n\n      * Mycophenolate mofetil (\\\u003C=3 g\u002Fday)\n      * Mycophenolate sodium (\\\u003C=2160 mg\u002Fday)\n      * Azathioprine (\\\u003C=200 mg\u002Fday)\n      * 6-mercaptopurine (\\\u003C=100 mg\u002Fday)\n      * Methotrexate (oral\u002Fsubcutaneous\u002Fintramuscular) (\\\u003C=25 mg\u002Fweek)\n6. Willing and able to provide written informed consent and comply with all aspects of the protocol\n\nExclusion Criteria\n\n1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\] test). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n2. Females of childbearing potential who:\n\n   1. Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:\n\n      * Total abstinence (if it is their preferred and usual lifestyle)\n      * An intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)\n      * A contraceptive implant\n      * Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral, injectable). Participants using hormonal contraceptives must be on a stable dose of the same contraceptive product for at least 28 days before dosing, throughout the study, and for at least 28 days following study drug discontinuation.\n      * Have a vasectomized partner with confirmed azoospermia\n   2. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation.\n   3. Participants on an oral contraceptive must use an additional barrier method throughout the study and for 28 days after study drug discontinuation.\n3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (ie, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 5 times the half-life of the study drug plus 90 days after study drug discontinuation.\n4. Drug-induced lupus erythematosus\n5. Active or unstable neuropsychiatric lupus (including but not limited to any condition defined by BILAG category A in neuropsychiatric organ system)\n6. Systemic autoimmune diseases other than SLE (eg, rheumatoid arthritis, Crohn's disease, systemic sclerosis \\[SSc\\], multiple sclerosis, polymyositis\u002F dermatomyositis \\[PM\u002FDM\\]) that may affect the assessment of SLE pathology at Screening. The participants with the following diseases may be included in the study\n\n   * Sjögren's syndrome secondary to SLE\n   * Antiphospholipid antibody syndrome (APS) secondary to SLE\n   * Mixed Connective Tissue Disease (MCTD) not meeting diagnostic criteria for PM and SSc\n7. Any clinically significant symptom or organ impairment found by chest X-ray, ophthalmic examination, vital signs, or ECG finding at Screening or Baseline, laboratory test at Screening that in the opinion of the investigator could affect the participants safety or interfere with the study assessments.\n8. Laboratory test results meeting any of the following criteria at Screening:\n\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN)\n   * Absolute neutrophil count (ANC) \\\u003C1,000 \u002FmcL\n   * Platelet count \\\u003C50,000 \u002FmcL\n   * Hemoglobin \\\u003C8.0 g\u002FdL\n9. Renal impairment falling under any of the following criteria at Screening:\n\n   * Urine protein\u002Fcreatinine ratio \\>2.0 g\u002FgCr\n   * Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \\[MDRD\\]) \\\u003C40 mL\u002Fmin\u002F1.73 m\\^2\n10. Received vaccination within 2 weeks before the first dose of study drug (4 weeks before in case of live\u002F live attenuated vaccines)\n11. Currently or previously receiving gene therapy for SLE (eg, CAR-T cell therapy)\n12. Currently enrolled in another clinical study or used any investigational drug or device (including E6742) within 28 days (or 5× the half-life, whichever is longer) before obtaining informed consent\n13. Any history of the following clinically significant infections:\n\n    * Infections requiring hospitalization or intravenous antibiotics, or administration of antiviral drugs, within 4 weeks before the first dose of study drug\n    * Active tuberculosis\n14. Any findings indicating a history of tuberculosis on chest X-ray at Screening\n15. Positive or repeated hold (indeterminate or intermediate) in tuberculosis test (Interferon-γ release assays) at Screening\n16. A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 millisecond (ms) according to central reading at Screening. If the QTcF machine read is greater than 440 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed 1 minute apart and the mean of the 3 QTcF values will be used for evaluation.\n17. A prolonged QTcF interval (mean QTcF \\>450 ms) as demonstrated by triplicated ECGs at Baseline. Has any risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome) or the use of concomitant medications that prolonged the QTcF interval (excluding hydroxychloroquine).\n18. Hypersensitivity to the study drug, drug product chemical derivate or any of the excipients at Screening\n19. Any history of or concomitant medical condition that in the opinion of the investigators would compromise the participants ability to safely complete the study\n20. Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without inpatient stay postoperatively need not result in exclusion if in the opinion of the investigator this operation does not interfere with study procedures and participant safety\n21. Positive on test at Screening for human immunodeficiency virus (HIV)\n22. Positive on test at Screening for hepatitis B virus (HBV) with a detectable (eg, hepatitis B virus surface \\[HBs\\] antigen reactive, HBs antibody, hepatitis B virus core \\[HBc\\] antibody, HBV deoxyribose nucleic acid (DNA)) or hepatitis C virus (HCV) with a detectable (eg, HCV ribonucleic acid (RNA) \\[qualitative\\], HCV antibody) viral load\n23. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics within 2 years before Screening\n24. History of drug or alcohol dependency or abuse within 2 years before Screening\n25. History or concurrent of malignancy, lymphoma, leukemia, or lymphoproliferative disease (except for basal cell skin cancer, squamous cell skin cancer, and cervical cancer that have been cured by surgical operation)\n26. Assessed to be inappropriate for clinical study by investigators","75 Years",{"count":53,"type":22},256,[25],"The main purpose of the study is to demonstrate the efficacy based on dose response of E6742 compared with placebo as defined by the proportion of participants achieving a response using the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA) with a low dose of oral corticosteroids (OCS) (prednisone or equivalent) at Week 24 in participants with systemic lupus erythematosus (SLE).",[29],{"date":34,"type":35},{"date":59,"type":35},"2026-03-31",{"date":61,"type":22},"2029-03-01",{"name":63,"class":42},"Eisai Co., Ltd.",54,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100563527","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dapirolizumab-pegol-in-study-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-100563527","NCT06617325","A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","PHOENYCS FLY","Inclusion Criteria:\n\n* Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)\n* Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:\n\n  a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \\\u003Clower limit of normal (LLN) OR complement C4 \\\u003CLLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:\n  1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)\n  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)\u002FAnti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)\n  3. Historical evidence for anti-dsDNA antibodies\n  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:\n\n     * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and\u002For a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND\n     * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND\n     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:\n     * Antimalarial treatment in combination with glucocorticoids and\u002For immunosuppressants or as stand-alone treatment if justified OR\n     * Treatment with glucocorticoids and\u002For immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)\n\n     Exclusion Criteria:\n* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition\n* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy\n* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \\[eg, curettage, electrodesiccation\\] not later than 4 weeks prior to the Screening Visit \\[V1\\]), basal cell carcinoma, or dermatological squamous cell carcinoma\n* Study participant has a mixed connective tissue disease, scleroderma, and\u002For overlap syndrome of these diseases with SLE\n* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study\n* Study participant has clinically significant active or latent infection\n* Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection\n* Study participants who have received live\u002Flive attenuated vaccines within 6 weeks prior to the first study medication infusion\n* Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol\n* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP\n* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP\n* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m2, or serum creatinine \\>2.5 mg\u002FdL, or participant has proteinuria \\>3g\u002Fday, or protein:creatinine ratio \\>340 mg\u002Fmmol at the Screening Visit","16 Years",{"count":75,"type":22},450,[77],"PHASE3","The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.",[29],[81,82,83,84],"Systemic lupus erythematosus","Dapirolizumab pegol","SLE","DZP",{"date":34,"type":35},{"date":87,"type":35},"2024-11-21",{"date":89,"type":22},"2028-05-31",{"name":91,"class":42},"UCB Biopharma SRL",238,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100559950","phase-2-a-phase-2-master-protocol-assessing-inebilizumab-and-blinatumomab-in-autoimmune-diseases-100559950","NCT06570798","A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases","A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases","\\*Subprotocol A and B are no longer recruiting participants\\*\n\nInclusion Criteria:\n\n* Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.\n* Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:\n\n  1. Antinuclear antibodies (ANA) ≥ 1:80\n  2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)\n  3. AntiSmith antibodies elevated to above normal (ie, positive results).\n* Subprotocol A and B (Subgroup 1): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria. The local biopsy report will be used.\n* Subprotocol A and B: SLE Disease Activity Index 2K ≥ 6.\n* Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg\u002Fmg.\n* Subprotocol B (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.\n* Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems\n* Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1\n* Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to Day 1:\n\n  1. Prednisone dose ≤ 20 mg\u002Fday (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days\n  2. Hydroxychloroquine dose ≤ 400 mg\u002Fday and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.\n  3. MMF dose ≤ 3 g\u002Fday or MPA dose ≤ 2160 mg\u002Fday and at a stable dose for 2 weeks.\n  4. AZA dose ≤ 2 mg\u002Fkg\u002Fday and at a stable dose for 2 weeks.\n  5. Methotrexate \\> 25 mg\u002Fweek and at a stable dose for 2 weeks\n  6. Leflunomide \\> 20 mg\u002Fday and at a stable dose for 2 weeks\n  7. Dapsone \\> 300 mg\u002Fday and at a stable dose for 2 weeks.\n* Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n* Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP \\> 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening.\n* Subprotocol C (Part A and Part B): Refractory disease defined as:\n* Active disease despite having received treatment with:\n\n  1. at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND\n  2. at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).\n* Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:\n\n  1. Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.\n  2. Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.\n* Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening.\n\nExclusion Criteria:\n\n* Subprotocol A, B and C: Receipt of a live and\u002For live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.\n* Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of \\\u003C 30 mL per minute per 1.73 m\\^2 of body surface area (calculated using the Modification of Diet in Renal Disease \\[MDRD\\] formula, with screening laboratory results for serum creatinine value).\n* Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease \\[ESRD\\]).\n* Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.\n* Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period.\n* Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).\n* Subprotocol A: Renal biopsy showing pure class V.\n* Subprotocol B: Active CNS Lupus within one year prior to screening.\n* Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.\n* Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).\n* Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.\n* Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1:\n\n  1. B-cell directed CAR T-cell and T-cell engager therapies\n  2. Total lymphoid irradiation\n  3. Bone marrow transplant\n  4. T-cell vaccination therapy\n  5. Natalizumab",{"count":101,"type":22},220,[25],"The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).",[29,105],"Active Refractory Rheumatoid Arthritis",[81,107,108,109,110],"Inebilizumab","Blinatumomab","Active refractory rheumatoid arthritis","Rheumatoid arthritis",{"date":34,"type":35},{"date":113,"type":35},"2025-07-16",{"date":115,"type":22},"2028-08-06",{"name":117,"class":42},"Amgen",58,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":127,"targetDuration":129,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100652816","sii-and-siri-as-prognostic-biomarkers-in-lupus-nephritis-100652816","NCT07780045","SII and SIRI as Prognostic Biomarkers in Lupus Nephritis","Emerging Inflammatory Biomarkers (SII and SIRI) for Predicting Disease Activity, Renal Flares and Outcomes in Lupus Nephritis: A Prospective Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria\n* Confirmed lupus nephritis according to ISN\u002FRPS classification\n\nExclusion Criteria:\n\n* Active infection, sepsis, or other concurrent inflammatory or autoimmune conditions\n* Malignancy or hematologic disorders affecting blood cell counts\n* Pregnancy\n* Use of medications significantly affecting blood counts (such as recent chemotherapy or G-CSF)\n* Incomplete medical records or anticipated loss to follow-up","70 Years",{"count":128,"type":22},100,"12 Months","OBSERVATIONAL","This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus nephritis.",[30,29,133],"Kidney Diseases",[135,136,137],"Systemic Immune-Inflammation Index SII","Systemic Inflammation Response Index SIRI","Lupus Nephritis Biomarkers","NOT_YET_RECRUITING","2026-08-19",{"date":34,"type":35},{"date":139,"type":22},{"date":143,"type":22},"2027-10-19",{"name":145,"class":146},"Assiut University","OTHER",{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100652789","phase-1-a-study-to-test-crt-402-in-refractory-autoimmune-disease-100652789","NCT07778446","A Study to Test CRT-402 in Refractory Autoimmune Disease","A Phase 1\u002F2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy.\n* Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria.\n* Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing.\n* Females of childbearing potential must have a negative pregnancy test before treatment.\n* Must be willing and able to attend study visits and follow all study requirements.\n\nExclusion Criteria:\n\n* Clinical suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the Investigator,\n* Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data,\n* Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,\n* History of bone marrow\u002F hematopoietic stem cell or solid organ transplantation,\n* Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis,\n* Pregnancy or lactation.",{"count":155,"type":22},34,[157,25],"PHASE1","Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies. CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset. This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).",[160,29,161,162],"Autoimmune Diseases","Systemic Scleroderma","Myositis",{"date":34,"type":35},{"date":165,"type":22},"2026-08-24",{"date":167,"type":22},"2029-08-01",{"name":169,"class":42},"Myeloid Therapeutics",1,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100626028","phase-3-a-study-to-evaluate-the-treatment-outcomes-of-subcutaneous-anifrolumab-in-immunosuppressant-nave-and-biologic-nave-systemic-lupus-erythematosus-100626028","NCT07430306","A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus","Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)","SUNFLOWER","Inclusion Criteria:\n\n1. Males or females aged 18 to 70 years of age.\n2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.\n3. ANA-positive per the Central Lab at screening:\n\n   (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)\n4. Must be on the standard therapy regimen: antimalarials with or without OCSs\n5. Must have at screening and baseline:\n\n   1. Clinical SLEDAI-2K ≥ 4 points OR\n   2. Clinical SLEDAI-2K \\\u003C 4 with GC dose ≥ 7.5 mg\u002Fday (prednisone equivalent)\n6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \\[TB\\]) or previous TB\n7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).\n8. No medical history or signs or symptoms of active TB prior to or during Screening.\n9. Body weight ≥ 40.0 kg\n10. Negative pregnancy test for females during screening\n11. Normal HPV test result within 2 years prior to Week 0 (Day 1).\n12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.\n13. Willing to not use any other forms of experimental treatment during the study.\n\nExclusion Criteria:\n\n1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.\n2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \\[INR\\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.\n3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.\n4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.\n5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.\n6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.\n7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.\n8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.\n9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).\n10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).\n11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.\n12. Confirmed positive test for hepatitis B.\n13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.\n14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).\n15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).\n16. Severe HZ or recurrent HZ.\n17. Malignancy. History of cancer, apart from:\n\n    (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).\n\n    (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).\n18. Received any SLE-related therapies other than antimalarials and GCs.\n19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.\n20. History of an anaphylactic reaction to human proteins or mAbs.\n21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.\n22. Blood transfusion or receipt of blood products except albumin.\n23. Received more than 2 investigational products for the SLE since time of diagnosis.\n24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.\n25. Concurrent enrollment in another clinical study with a study intervention.\n26. Subjects with any abnormal lab result as specified in the protocol.\n27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).\n28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.\n29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).\n30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.\n31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.\n32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.\n33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).\n34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.",{"count":180,"type":22},245,[77],"The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.\n\nPatients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.",[29],[28,185,186,187,188],"Immunosuppressant","Glucocorticoid","Anifrolumab","Remission",{"date":32,"type":35},{"date":191,"type":35},"2026-04-13",{"date":193,"type":22},"2029-01-26",{"name":195,"class":42},"AstraZeneca",104,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100624403","phase-2-a-study-to-test-whether-different-doses-of-bi-3000202-help-people-with-systemic-lupus-erythematosus-sle-100624403","NCT07409181","A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)","Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \\\u003C75 years\n2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria at least 24 weeks prior to screening\n3. At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody\n\n   \\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points\n4. At least 1 British Isles Lupus Assessment Group (BILAG) A and\u002For 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator\n5. On SLE background therapy with a maximum of 1 immunosuppressant and\u002For 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and\u002For oral corticosteroids at a dose of ≤30 mg\u002Fday prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Drug-induced SLE\n2. Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments\n3. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis\u002Fmononeuropathy multiplex, chorea, and polyneuropathy\n4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \\>2 × Upper Limit of Normal (ULN) and\u002For Urine Protein Creatinine Ratio (UPCR) that is unstable or \\> 3mg\u002Fmg (339 mg\u002Fmmol)\n5. Oral corticosteroids (prednisone or equivalent) \\>30 mg\u002Fday at screening Further exclusion criteria apply.","74 Years",{"count":206,"type":22},405,[25],"This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.\n\nParticipants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.\n\nParticipants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.",[29],[28],{"date":32,"type":35},{"date":213,"type":35},"2026-04-20",{"date":215,"type":22},"2029-07-08",{"name":217,"class":42},"Boehringer Ingelheim",140,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":170},"100473094","phase-2-the-role-of-anifrolumab-in-improving-markers-of-vascular-risk-in-patients-with-systemic-lupus-erythematosus-sle---ifn-cvd-100473094","NCT05440422","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-80 years\n4. In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.\n5. Prednisone \\\u003C or equal to 10 mg\u002Fday for at least 2 weeks before screening and maintained throughout randomization (day 1)\n6. Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)\n7. Abnormal cardio-ankle vascular index (CAVI) (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts AND\u002FOR\n8. Abnormal Pulse wave velocity (PWV) using Sphygmocor. AND\u002FOR\n9. Abnormal target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scan.\n10. Stable medications for diabetes, hypertension and\u002For statins for at least the previous 3 months. No changes of these medications or immunosuppressive drugs will be allowed during trial.\n11. For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.\n12. Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.\n\n    EXCLUSION CRITERIA:\n\n    An individual who meets any of the following criteria will be excluded from participation in this\n\n    study:\n    * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n    * Concurrent enrolment in another clinical study with an investigational product\n    * Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.\n    * Any of the following found at Screening:\n\n      * Aspartate aminotransferase (AST) \\>2.5 x upper limit of normal (ULN).\n      * Alanine aminotransferase (ALT) \\>2.0 x ULN.\n      * Total bilirubin \\>ULN (unless due to Gilbert's syndrome)\n      * Serum creatinine \\>2.5 mg\u002FdL (or \\>181 micromol\u002FL)\n      * Urine protein\u002Fcreatinine ratio \\>2.0 mg\u002Fmg (or \\>226.30 mg\u002Fmmol)\n      * Neutrophil count \\\u003C1000\u002FmicroL (or \\\u003C1.0 x 109\u002FL)\n      * Platelet count \\\u003C25000\u002FmicroL (or \\\u003C25 x 109\u002FL)\n      * Hemoglobin \\\u003C8 g\u002FdL (or \\\u003C80 g\u002FL), or \\\u003C7 g\u002FdL (or \\\u003C70 g\u002FL) if related to subject's SLE such as in active hemolytic anemia\n      * Glycosylated hemoglobin (HbA1c) \\>8% (or \\>0.08) at screening (diabetic subjects only). Patients with HbA1c \\>8% may be eligible for study if considered to be at low risk of infection and vascular complications at the discretion of study PI.\n      * Positive SARS\u002FFlu A\u002FB\u002FRSV (Panther), PCR - risk-based testing, only required if patient is symptomatic or has been exposed to someone with the virus.\n\n    Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.\n    * Receipt of any of the following:\n\n      1. Azathioprine \\>200 mg\u002Fday\n      2. Mycophenolate mofetil \\> 3 g\u002Fday or mycophenolic acid \\>2.16 g\u002Fday\n      3. Oral, SC, or intramuscular methotrexate \\>25 mg\u002Fweek\n      4. Mizoribine \\>150 mg\u002Fday. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.\n    * Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.\n    * Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF\n    * Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), \\\u003C26 weeks prior to the signing of the consent for all B-cell depleting therapy or \\\u003C40 weeks prior to the signing of the ICF for atacicept.\n    * Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)\n    * History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.\n    * Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))\n    * Active SLE disease with SLEDAI 2K \\>6 at the time of screening.\n    * Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex:\n\n      1. That would make the subject unable to fully understand the ICF OR\n      2. Where, in the opinion of the Principal Investigator (PI), protocol specified SOC is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated\n    * Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n    * History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.\n    * Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.\n    * Confirmed positive test for hepatitis B serology for:\n\n      1. Hepatitis B surface antigen (HBsAg), OR\n      2. Hepatitis B core antibody (HBcAb)\n      3. If positive for HBcAb, hepatitis B virus (HBV) DNA will be checked. If HBV DNA is detected above the lower limit of quantitation (LLOQ) at screening subject will be excluded\n\n    Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.\n    * Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.\n    * Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)\n    * Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n    * Any of the following:\n\n      1. Clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to week 0 (day1) (chronic nail infections are allowed)\n      2. Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to week 0 (day1)\n    * Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals\u002Fantimicrobials prophylactically.\n    * History of cancer, apart from:\n\n      1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy \\>=3 months prior to Week 0 (Day 1)\n      2. Cervical cancer in situ treated with apparent success with curative therapy \\>=1 year prior to Week 0 (Day 1).\n    * Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.\n    * Spontaneous or induced abortion, still or live birth, or pregnancy \\\u003C= 4 weeks prior to week 0 (day1)\n    * Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.\n    * Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.","80 Years",{"count":228,"type":22},45,[25],"Background:\n\nPeople with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.\n\nObjective:\n\nTo test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.\n\nEligibility:\n\nPeople aged 18 to 80 years with SLE.\n\nDesign:\n\nParticipants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.\n\nParticipants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.\n\nParticipants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.\n\nAt some visits they will have additional tests:\n\nCAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.\n\nFDG-PET\u002FCT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.",[29,232,233],"Cardiovascular Disease","Premature Atherosclerosis",[235,236,237],"Vascular Inflammation","Interferons","Vascular Function",{"date":32,"type":35},{"date":240,"type":35},"2023-12-07",{"date":242,"type":22},"2027-08-02",{"name":244,"class":245},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":126,"enrollmentInfo":253,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":170},"100612253","characterization-of-autoreactive-b-lymphocytes-in-autoimmune-diseases-and-immune-deficiencies-100612253","NCT07251179","Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies","AutoB-Tetramer","Inclusion Criteria:\n\n* Patients aged between 18 and 70\n* Patients for whom at least one of the following conditions has been confirmed:\n* Systemic lupus erythematosus meeting the 2019 ACR\u002FEULAR classification criteria.\n* Systemic scleroderma meeting the 2013 ACR\u002FEULAR classification criteria. ANCA-associated vasculitis according to the 2022 EULAR\u002FACR classification criteria.\n* Antiphospholipid syndrome according to the 2023 ACR\u002FEULAR criteria.\n* Primary immunodeficiencies according to IUIS criteria.\n* Patients capable of understanding the objectives of the research.\n* Patients affiliated with a social security health insurance scheme (beneficiary or dependant).\n* Patients who have signed and dated the informed consent form for non-identifying genetic testing.\n\nExclusion Criteria:\n\n* Patient refusing to participate in the study\n* Patient in a period of exclusion (determined by a previous or ongoing study) Inability to provide the subject with informed consent (in an emergency or immediate life-threatening situation, difficulties in understanding the subject, etc.)\n* Patient under legal protection\n* Patient under guardianship or conservatorship",{"count":254,"type":22},200,"Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase. Many AIDs are linked to the emergence of autoreactive B cells (BCs) directed against components of the self. In healthy individuals, these autoreactive B cells are counter-selected or regulated before reaching the antibody-secreting cell compartment. However, in predisposed individuals, a breakdown in B cell tolerance can occur, leading to the formation of autoantibodies with devastating consequences, such as the emergence of systemic lupus erythematosus (SLE), rheumatoid arthritis, and vasculitis. B-cell depletion is often beneficial in these patients, but paradoxically, therapies targeting B cells are not always effective. Furthermore, B cell depletion via LB-specific antibodies (anti-CD20) or treatment with CD19 chimeric antigen receptor T cells (CAR T) leads to complete and prolonged depression of the entire B compartment without targeting the LB population responsible for the onset of the disease. To date, two pitfalls in studies of human autoreactive LBs often complicate the interpretation of results:\n\ni) the difficulty of identifying autoreactive LBs among all LBs, ii) demonstrating the pathogenicity of autoreactive B lymphocytes when they can be identified individually. We propose to quantify and phenotype these autoreactive\u002Fpathogenic B cells using high-throughput flow cytometry in several clinical situations.",[29,161,257,258,259],"ANCA-associated Vasculitis","Antiphospholipid Syndrome","Primary Immunodeficiencies","2026-08-18",{"date":32,"type":35},{"date":263,"type":35},"2026-01-20",{"date":265,"type":22},"2031-12-31",{"name":267,"class":146},"University Hospital, Strasbourg, France",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":276,"minAge":19,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":170},"100596759","anifrolumab-pregnancy-study-100596759","NCT07049653","Anifrolumab Pregnancy Study","A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab","ROSE","Inclusion criteria for EXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women exposed to anifrolumab (polytherapy, added to SLE SOC) during pregnancy and\u002For 16-week period prior to LMP2\n\nExclusion criteria for EXPOSED SOURCE POPULATION:\n\n\\- Pregnancies whose date of conception cannot be established\n\nInclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women with a continuous enrolment in the database for ≥ 12 months prior to LMP2\n* Women diagnosed with SLE before pregnancy\n* Women treated with SLE SOC during pregnancy\n\nExclusion criteria for UNEXPOSED SOURCE POPULATION:\n\n* Women treated with anifrolumab during pregnancy and\u002For 16-week period prior to LMP2\n* Pregnancies whose date of conception cannot be established\n\nInclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n\\- Women with moderate\u002Fsevere SLE\n\nExclusion criteria for EXPOSED and UNEXPOSED STUDY POPULATION:\n\n* Women with a history of CM or chromosomal abnormalities (according to available records), before delivery\n* Women prescribed a confirmed teratogenic drug prior to LMP2 with a time period of 5-half-lives of relevant drug or during pregnancy","FEMALE","130 Years",{"count":279,"type":22},500,"This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.",[29],[283],"pregnancy, anifrolumab, SLE",{"date":139,"type":35},{"date":286,"type":35},"2026-06-04",{"date":288,"type":22},"2030-12-10",{"name":195,"class":42},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":298,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":304,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100500678","phase-3-effects-of-stopping-hydroxychloroquine-in-elderly-lupus-disease-100500678","NCT05799378","Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease","A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease","SHIELD","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age ≥ 55 years at time of enrollment\n* Normal OCT and VF assessment within 6 months of screening visit\n* Ability to take oral medication\n* Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)\n* Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.\n\n  * Criterion 1: Clinical SLEDAI= 0\n  * Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is no disease activity and 3 is maximum disease activity)\n  * Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily\n* No moderate or severe flares one year prior to screening\n* Taking ≥ 200 HCQ daily for ≥ 7 years\n\nExclusion Criteria:\n\n* Any patient that does not attain stable disease status by DORIS\n* Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)\n* Clinical SLEDAI \\> 0\n* Taking \\> 5 mg\u002Fday prednisone\n* Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)\n* Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI\n* HCQ level \\\u003C 100 ng\u002Fml as this would support noncompliance and less reliance on HCQ to control activity\n* Patient unwilling or unable to comply with study procedures for any reason\n* Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)","55 Years",{"count":300,"type":22},330,[77],"Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients \\>=55 years old. The central hypothesis is that HCQ can be safely discontinued in stable\u002Fquiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 3 months for one year to assess disease activity and flares.",[29],[305,306,307,308,309,310],"Hydroxychloroquine","systemic lupus erythematosus","elderly lupus disease","lupus","sle","plaquenil",{"date":32,"type":35},{"date":313,"type":35},"2024-06-27",{"date":315,"type":22},"2029-06-30",{"name":317,"class":146},"NYU Langone Health",12,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":325,"phases":4,"briefSummary":326,"conditions":327,"keywords":341,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":349,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":350,"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.",[328,329,330,331,332,333,334,335,336,337,29,338,339,340],"Crohn Disease","Ulcerative Colitis","Idiopathic Arthritis (Including sJIA, pJIA, or JPsA)","Atopic Dermatitis","Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis","Non-radiographic Axial","Spondyloarthritis","Giant Cell Arteritis","Alopecia Areata","Non Segmental Vitiligo","Hidradenitis Suppurativa",[342,343,344,345,346,347],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE",{"date":32,"type":35},{"name":351,"class":42},"AbbVie",{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":276,"minAge":19,"maxAge":277,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":170},"100561738","phase-4-prospective-registry-investigating-maternal-infant-and-lactation-outcomes-in-anifrolumab-users-100561738","NCT06594068","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users","PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab","PRIMULA Lac","Inclusion Criteria:\n\nMaternal:\n\n1. 18 years or older\n2. Signed informed consent to participate\n3. Diagnosis of moderate\u002Fsevere SLE\n4. Ongoing treatment with anifrolumab\n5. Has reached or will reach steady state (\\~85 days postpartum, equivalent to at least 3 consecutive previous IV doses or at least 12 previous SC doses during the post-partum period) with anifrolumab by the time of study Day 1 (pre-dose milk collection)\n6. Established lactation in the index post-partum period (breastfeeding or pumping for at least 4 weeks at time of Day 1 visit to ensure mature milk production)\n7. Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection on Day 1 post IV dose\n8. Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning\n9. Must be exclusively breast milk-feeding their infant (or if not exclusively breast milk-feeding, not providing more than 1 supplemental bottle of formula per day) at the time of enrollment and throughout the study period\n10. Agrees to use only lanolin nipple cream during the sampling period\n\nInfant:\n\n1. Gestational age at delivery ≥32 weeks\n2. Birthweight \\> 10th percentile\n3. Weight \\> 10th percentile at the time of enrollment\n\nExclusion Criteria:\n\nMaternal:\n\n1. Received any investigational compound or approved biologic or biosimilar within 30 days or 5 half-lives (whichever is longer) prior to enrollment in the study\n2. Diagnosis of lupus nephritis in the last 12 months\n3. History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts\n4. History of malignancy in the last 10 years\n5. History of mastectomy\n6. Evidence of mastitis or any other significant active infection at Day 1 (pre-dose)\n\nInfant:\n\n1\\. Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant participant at risk by participating in the study",{"count":361,"type":22},16,[363],"PHASE4","Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who are receiving anifrolumab therapeutically via intravenous (IV) or subcutaneous (SC) administration and evaluate exposure and effects on the breastfed infant.",[29],[367,368,369,370,371,372],"Chronic autoimmune disease","Immunosuppressants","Corticosteroids","Human monoclonal antibody (IgG1ƙ mAb)","Post Marketing Requirements (PMR) study","Systemic Lupus Erythematosus (SLE)","2026-08-17",{"date":260,"type":35},{"date":376,"type":35},"2026-01-16",{"date":378,"type":22},"2027-08-31",{"name":195,"class":42},{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":384,"conditions":391,"keywords":392,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100525404","phase-1-reset-sle-a-phase-12-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-in-subjects-with-active-systemic-lupus-erythematosus-100525404","NCT06121297","RESET-SLE: A Phase 1\u002F2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus","A Phase 1\u002F2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥18 and ≤65\n* A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for adult SLE.\n* Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.\n* For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria\n* For non-renal SLE subjects only: Active, moderate to severe SLE\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* For LN subjects only: The presence of kidney disease other than active lupus nephritis\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.","65 Years",{"count":389,"type":22},28,[157,25],[29,30],[393,394,395,396,29,30],"CABA-201","Autoimmune Disease","Anti-CD19 CAR-T therapy","Cellular Therapy",{"date":260,"type":35},{"date":399,"type":35},"2024-02-16",{"date":401,"type":22},"2029-12",{"name":403,"class":42},"Cabaletta Bio",23,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":412,"sex":18,"minAge":413,"maxAge":414,"enrollmentInfo":415,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":4,"leadSponsor":427,"locationsCount":170},"100054418","study-of-systemic-lupus-erythematosus-100054418","NCT00001372","Study of Systemic Lupus Erythematosus","Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)","* INCLUSION CRITERIA:\n\nPatients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans and Hispanics. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient s permission to contact his\u002Fher relatives.\n\n* SLE or suspected SLE established by ACR\u002FEULAR or ACR criteria\n* Ability to give informed consent\n* Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)\n* Ability of the patient or minor relative s parents to give informed consent\n* Affected individuals age \\>= 3 years with no upper age limit\n* Healthy Volunteers (non-related) age \\>=18 with no upper age limit\n* Healthy Volunteers (first- and second-degree relatives) age \\>=3 with no upper age limit\n* Vascular studies adults only age \\>=18 with no upper age limit\n\nEXCLUSION CRITERIA:\n\n* Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.\n* Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH\n* Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)\n* Any comorbidity of medical or psychological\u002Fpsychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and\u002For acute medical care, surgical or other procedures)\n* Unwilling to participate in research studies or to provide research samples or data\n* Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for\n\nEXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:\n\n* Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:\n\n  * Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI\n  * Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI\n  * Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI\n  * Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n* Subjects with renal excretory dysfunction, estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2 using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.\n* Pregnant or lactating women will be excluded from vascular studies.\n* Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.\n* Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.\n* Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.",true,"3 Years","120 Years",{"count":416,"type":22},2000,"This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.\n\nPatients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include:\n\n1. Electrocardiogram\n2. 24-hour urine collection\n3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.\n4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.\n5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm.\n6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1\u002F4 inch in diameter) is removed, using a sharp cookie cutter-type instrument.\n7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions.\n8. Genetic studies-Collection of a blood sample for gene testing.\n\nPatients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll.\n\nParticipating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing....",[29],[420,421,30,28,422,83],"Longitudinal Study","Natural History","Systemic Lupus","2026-08-15",{"date":260,"type":35},{"date":426,"type":35},"1994-02-10",{"name":244,"class":245},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":436,"maxAge":126,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100636836","phase-2-a-phase-2-open-label-single-arm-trial-of-ft819-in-participants-with-lupus-nephritis-100636836","NCT07570862","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)","RECLAIM-LN","INCLUSION CRITERIA:\n\n* Age ≥12 to ≤70 years\n* Diagnosis of SLE per EULAR\u002FACR 2019 classification criteria\n* Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003\u002F2018 ISN\u002FRPS classification\n* Positivity for at least one of the following autoantibodies at screening:\n\n  1. Antinuclear antibody (ANA)\n  2. Anti-double-stranded DNA (anti-dsDNA) or\n  3. Anti-Smith antibody\n* Active disease, defined as:\n\n  a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g\u002Fg; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible\n* Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN\n\nEXCLUSION CRITERIA:\n\n* Evidence of inadequate organ function during the screening period\n* Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention\n* History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity\n* Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention\n* Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant\n* History of malignancy in the prior 5 years\n* Known allergy to the following FT819 components: albumin (human) or DMSO\n* History of intolerance or contraindication to bendamustine\n* Body weight \\\u003C30 kg\n* Any medical condition, clinical laboratory abnormality, or nonmedical\u002Fsocial issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results","12 Years",{"count":438,"type":22},53,[25],"The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.",[30,29,442,443,444],"SLE - Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[446,447,448,449,30,29],"FT819","Fate Therapeutics","Allogeneic CAR T","CD19 - targeted therapy","2026-08-13",{"date":373,"type":35},{"date":453,"type":35},"2026-07-27",{"date":455,"type":22},"2030-01-31",{"name":447,"class":42},6,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":170},"100551283","intervention-to-improve-communication-and-medication-adherence-in-lupus-100551283","NCT06458075","Intervention to Improve Communication and Medication Adherence in Lupus","Intervention to Improve Patient-provider Communication and Medication Adherence Among Patients With Systemic Lupus Erythematosus (SLE)","CO-LEAD","Clinician Inclusion Criteria:\n\n1. Adult rheumatology attendings, advanced practice providers, and fellows at the two academic institutions\n2. Clinicians who have ambulatory rheumatology care at least ½ day per week\n\nClinician Exclusion Criteria:\n\n1. Clinicians at Duke University who were involved in the investigators' pilot work\n2. Clinicians with an anticipated departure from the institution in the 12 months following enrollment\n\nPatient Inclusion Criteria:\n\n1. 18 years or older\n2. English-speaking, able to provide consent\n3. Diagnosed with SLE and receiving care with enrolled clinicians\n4. Prescribed at least one SLE medication, and filling their SLE mediations at a pharmacy linked to Surescripts reporting visible in Epic EMR.\n\nPatient Exclusion Criteria:\n\n1. Non-English speakers\n2. Patients who are prescribed only corticosteroids for SLE\n3. Patients who are accompanied by third-party member that is not willing or able to remain in the waiting room during the patient's visit and\n\n   * Does not wish to be audio recorded\n   * A minor without a parental\u002Flegal guardian and\u002For\n   * Unable to give consent","90 Years",{"count":468,"type":22},480,[470],"NA","CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE).\n\nThe purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following:\n\n1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers.\n2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.",[29],{"date":373,"type":35},{"date":475,"type":35},"2024-07-01",{"date":477,"type":22},"2028-12",{"name":479,"class":146},"Duke University",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":488,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":128},"100503442","phase-3-an-efficacy-and-safety-study-of-intravenous-anifrolumab-to-treat-systemic-lupus-erythematosus-in-pediatric-participants-100503442","NCT05835310","An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants","A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to \u003C 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy","BLOSSOM","Inclusion Criteria:\n\n* Participant's parent\u002Fcaregiver\u002Flegally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) criteria for at least 3 months prior to signing the ICF.\n* At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as:\n\n  (a) SLEDAI-2K activity of: (i) ≥ 6 points with at least 4 points (≥ 4 points) coming from the following clinical components ('Clinical' SLEDAI-2K score): arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis and excluding points attributed to a fever, SLE headache, and organic brain syndrome (ii) Clinical SLEDAI score of ≥ 4 points verified at Day 1 (b) BILAG-2004 activity of: (i) ≥ 1 BILAG A score; or (ii) ≥ 2 BILAG B scores (c) PGA score ≥ 1.0 on a 0 to 3 VAS\n* Participant should meet all of following tuberculosis (TB) criteria:\n\nA. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit\n\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.\n* Female participants of childbearing and male participants must adhere to the contraception methods.\n\nExclusion Criteria:\n\n* Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.\n* History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.\n* In participants aged 11 years and above: history or evidence of suicidal ideation.\n* History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.\n* Any positive result on screening for human immunodeficiency virus.\n* Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active or recent case of Herpes Zoster infection.\n* Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n* History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild\u002Fasymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).\n* Prior use of anifrolumab.\n* Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) \\\u003C 26 weeks prior to ICF signature.\n* Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.","5 Years","17 Years",{"count":128,"type":22},[77],"A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)",[29],[29,83,495,187,496,497,498,499],"Monoclonal Antibody","Parallel-group treatment","Pediatric participants","Standard of care therapy","Intravenous",{"date":501,"type":35},"2026-08-14",{"date":503,"type":35},"2024-03-14",{"date":505,"type":22},"2030-01-09",{"name":195,"class":42},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":277,"enrollmentInfo":515,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":528},"100592951","anifrolumab-malignancy-and-serious-infections-study-100592951","NCT07000110","Anifrolumab Malignancy and Serious Infections Study","A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab","SIMA","Inclusion Criteria:\n\n* First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date\n* A minimum data availability of 12 months prior to index date\n* Age ≥18 years at index date\n* SLE severity: patients with moderate to severe SLE at index date\n* SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date\n\nExclusion Criteria:\n\n* A diagnosis of any malignancy prior to index date\n* A diagnosis of HIV\u002FAIDS or congenital immunodeficiency prior to index date\n* Organ or bone marrow transplant procedure prior to index date\n* A diagnosis of serious infection in the previous 6 months",{"count":516,"type":22},3506,"This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate\u002Fsevere SLE patients who receive anifrolumab compared with a comparable population of moderate\u002Fsevere SLE patients on standard of care who do not initiate anifrolumab.",[29],[520],"malignancies, infections, anifrolumab","2026-08-12",{"date":450,"type":35},{"date":524,"type":35},"2026-01-26",{"date":526,"type":22},"2031-11-30",{"name":195,"class":42},4,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":170},"100633176","phase-1-safety-and-preliminary-efficacy-of-hn2302-in-patients-with-autoimmune-diseases-100633176","NCT07523282","Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","AID","Inclusion Criteria:\n\n* Adults aged 18 to 69 years, regardless of gender.\n* Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.\n* Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA antibody, and\u002For hypocomplementemia.\n* Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.\n\nExclusion Criteria:\n\n* Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.\n* Presence of any other uncontrolled active infection.\n* History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow\u002Fhematopoietic stem cell transplantation.\n* Pregnant or breastfeeding women.\n* Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.\n* History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.\n* Receipt of a live vaccine within 30 days before screening.\n* History of asthma or severe allergy, if considered clinically significant by the investigator.\n* Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.","69 Years",{"count":318,"type":22},[157],"This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).",[394,29,542],"Systemic Sclerosis (SSc)",[83,544],"SSc","2026-08-11",{"date":521,"type":35},{"date":548,"type":22},"2026-12-31",{"date":550,"type":22},"2028-06-30",{"name":552,"class":42},"Shenzhen MagicRNA Biotechnology Co., Ltd",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":537,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":170},"100577655","phase-1-efficacy-and-safety-of-hn2301-in-autoimmune-diseasesaids-100577655","NCT06801119","Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）","Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）","SLE，SSc，RA","Inclusion Criteria:\n\n* Patients aged between 18 and 69 (inclusive), of any gender;\n* Appropriate bone marrow, coagulation, cardiopulmonary, liver, and kidney functions. Bone marrow function: ANC ≥1.5×10\\^9\u002FL, ALC ≥0.8×10\\^9\u002FL, Hb ≥80g\u002FL. No use of transfusions and growth factors allowed within 7 days prior to screening to meet these requirements. Coagulation function: INR or APTT ≤1.5×ULN. Cardiac function: Echocardiography (ECHO) assessment of left ventricular ejection fraction (LVEF) ≥40%. Lung function: ≤CTCAE grade 1 dyspnea and SpO2 ≥92% (measured by pulse oximetry) while breathing indoor air. Liver function: ALT and AST ≤2.5×ULN, total bilirubin \\\u003C2.0mg\u002FdL (Gilbert syndrome subjects total bilirubin \\\u003C3.0mg\u002FdL). Kidney function: defined as creatinine clearance rate (Cockcroft-Gault) ≥50mL\u002Fmin without need for fluid assistance;\n* Non-pregnant\u002Fnon-lactating participants, willing to adopt contraceptive measures within 12 months after drug infusion;\n* Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE diagnostic criteria; A history of SLE for at least 6 months, having used a stable standard treatment regimen for at least 8 weeks; Oral corticosteroids are prednisone (or equivalent drug) ≥7.5mg\u002Fday and ≤30mg\u002Fday. At least two immunosuppressants have been used in a standardized manner (including hydroxychloroquine); Screening period tests meet: positive blood antinuclear antibody (ANA), and\u002For positive anti-ds-DNA antibodies, and\u002For hypocomplementemia;\n* SSc-meets the classification criteria of ACR and EULAR, 10-35 in mRSS score;\n* RA-meets the classification criteria of ACR and EULAR, DAS28-ESR\\>3.2, ACPA possitive.\n\nExclusion Criteria:\n\n* Individuals with positive Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb), and Hepatitis B virus (HBV) DNA positivity or titers above the detection threshold; those with positive Hepatitis C virus (HCV) antibodies and HCV RNA positivity or titers above the detection threshold; individuals with Human Immunodeficiency Virus (HIV) antibodies positivity, CMV DNA positivity or above the detection limit; those with positive syphilis antigen or antibodies;\n* Presence of other uncontrolled active infections;\n* History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women;\n* Receiving any mRNA-LNP product or other LNP medications within the past two years;\n* History of any of the following cardiovascular diseases within the last 6 months before screening: Class III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant cardiac diseases;\n* History of live vaccine administration within the last 30 days;\n* Individuals with asthma, severe allergies;\n* Other conditions deemed inappropriate for participation in this clinical study by the investigator.",{"count":21,"type":22},[157],"This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）",[29,565,332],"Scleroderma",[567],"SLE, SSc,RA",{"date":521,"type":35},{"date":570,"type":35},"2025-03-16",{"date":550,"type":22},{"name":552,"class":42},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":276,"minAge":4,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":170},"100577253","the-anifrolumab-prim-program-100577253","NCT06795893","The Anifrolumab PRIM Program","Pregnancy and Infant Outcomes in Anifrolumab Exposed Pregnancies Using PRegnancy Outcomes Intensive Monitoring (PRIM) Data: The Anifrolumab PRIM Program","PRIM","Inclusion Criteria:\n\n* Currently or recently (within 1 year of pregnancy outcome) pregnant\n* Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception\n\nExclusion Criteria:\n\n* Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.",{"count":582,"type":22},240,"Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program",[29],[586,587,588,589,590,591,29],"chronic autoimmune disease","immunosuppressants","corticosteroids","human monoclonal antibody (IgG1ƙ mAb)","post Marketing Requirements (PMR) study","pregnancy","2026-08-10",{"date":545,"type":35},{"date":595,"type":35},"2025-11-07",{"date":597,"type":22},"2031-04-15",{"name":195,"class":42},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":412,"sex":18,"minAge":19,"maxAge":387,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":612,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":619,"leadSponsor":620,"locationsCount":170},"100650827","phase-1-a-study-of-qls2404-injection-in-healthy-participants-and-participants-with-rheumatic-autoimmune-diseases-100650827","NCT07751315","A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","A Phase Ia\u002FIb Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases","Inclusion Criteria:\n\n* Ia\n* Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.\n* Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.\n* Body mass index (BMI) at screening ≥19 kg\u002Fm² and ≤26 kg\u002Fm², with body weight ≥45 kg.\n* Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period.\n* Ib\n* Participants who voluntarily sign the informed consent form before the initiation of any study-related procedures, are able to communicate effectively with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol, and complete the study.\n* Male or female participants aged ≥18 and ≤65 years at the time of signing the informed consent form.\n* Body mass index (BMI) at screening ≥18 kg\u002Fm² and ≤35 kg\u002Fm².\n* Participants with systemic lupus erythematosus must meet the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE and be diagnosed with systemic lupus erythematosus; the diagnosis must have been established at least 6 months prior to signing the informed consent form.\n* Participants with primary Sjögren's syndrome must meet the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome and be diagnosed with primary Sjögren's syndrome; the diagnosis must have been established at least\n* months prior to signing the informed consent form.\n\nExclusion Criteria:\n\n* Ia\n* QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.\n* Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.\n* Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.\n* Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons.\n* Ib\n* Any disease or condition that, in the investigator's opinion, may interfere with the evaluation of study drug efficacy, participant safety assessment, or interpretation of study results.\n* Participants who have participated in any cell therapy, gene therapy clinical trial, or medical device clinical trial within 3 months prior to screening.\n* Participants who have received Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.\n* Participants who have received any live attenuated vaccine within 1 month prior to screening or who require live attenuated vaccination during study participation.\n* Participants who are breastfeeding or have a positive serum human chorionic gonadotropin (hCG) test during the screening period.",{"count":607,"type":22},64,[157],"This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.",[29,611],"Primary Sjögren's Syndrome",[306,613,83,614],"primary Sjögren's syndrome","pSS","2026-08-06",{"date":617,"type":35},"2026-08-07",{"date":545,"type":22},{"date":550,"type":22},{"name":621,"class":42},"Qilu Pharmaceutical Co., Ltd.",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":629,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":641,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":170},"100606821","creating-health-course-study-for-people-with-rheumatological-conditions-and-mood-disorders-100606821","NCT07180537","Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders","Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions and Mood Disorders","Inclusion criteria:\n\n1. A diagnosis of one of the following: Rheumatoid Arthritis (RA), Sjogren's Syndrome, Systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), or Psoriatic Arthritis (PsA), as documented by their treating specialist or primary care provider, as reported by the participant.\n2. Must be age 18 and older, at time of consent.\n3. Must be fluent in both speaking and reading English.\n\n   \\*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.\n4. Must have access to high-speed internet with devices capable of audio\u002Fvideo streaming.\n5. Must be willing to participate in an online health course designed to improve dietary intake and self-care routines to help improve cellular function and health, and complete online surveys over the course of a 6-month period.\n6. Individuals must pass the Short Portable Mental Status Questionnaire with scores for normal mental functioning (up to 2 errors). Cognitive impairment as measured by the SPMS Questionnaire could interfere with the completion of the online course.\n\nSCORING\\* 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8-10 errors: severe cognitive impairment\n\n\\*Allow one more error for a subject with only a grade school education. Allow one less error for a subject with education beyond high school.\n\nSource: Pfeiffer, E. (1975). A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. Journal of American Geriatrics Society. 23, 433-41.\n\nExclusion criteria:\n\n1. Inability to provide informed consent, including participation in a consent call conducted via Zoom with the study team during business hours (8:00 a.m. to 5:00 p.m. Central Time (Chicago)).\n2. Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.\n3. Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.\n4. Any diagnosis or condition that is contraindicated from starting a gentle exercise program (ex. poorly controlled diseases of the heart, kidney, or liver in the prior 12 months, or severe psychiatric disease, e.g., schizophrenia, making adherence to study procedures difficult.","100 Years",{"count":631,"type":22},400,[470],"The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression.\n\nAdditionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.",[332,635,29,636,333,637,638,639,640],"Sjogren's Syndrome","Mixed Connective Tissue Disease","Anxiety Disorders","Depressive Disorders","Moderate Depression","Moderate Anxiety",[642,643,644,645,646,647,648,308,649,650],"diet","self-care","internet course","anxiety","depression","Sjogren's","rheumatoid arthritis","fatigue","arthritis",{"date":592,"type":35},{"date":653,"type":35},"2025-12-01",{"date":655,"type":22},"2027-12-31",{"name":657,"class":146},"Terry L. Wahls"]