[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-lupus-erythematosus-cle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-lupus-erythematosus-cle":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,58,81,116,142,164,187,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100618504","phase-3-a-study-of-enpatoran-in-participants-with-cutaneous-manifestations-of-lupus-with-or-without-systemic-disease-100618504",false,"NCT07332481","A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease","A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)","ELOWEN-1","Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines\u002Frecommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and\u002For Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and\u002For SCLE and\u002For ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR\u002FACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor\u002Fdesignee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg\u002Fmmol), and\u002For estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL\u002Fmin\u002F1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","ALL","18 Years","75 Years",{"count":21,"type":22},202,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.",[28,29],"Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)",[31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus (DLE)","Subacute Cutaneous Lupus Erythematosus (SCLE)","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus (ACLE)","Interferon gene signature","RECRUITING","2026-07-01",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2026-03-10",{"date":53,"type":22},"2029-05-24",{"name":55,"class":56},"EMD Serono Research & Development Institute, Inc.","INDUSTRY",11,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100626815","phase-2-evaluate-the-efficacy-and-safety-of-icp-488-in-subjects-with-cutaneous-lupus-erythematosus-cle-double-blind-study-100626815","NCT07440537","Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study","A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of Oral ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE)","Inclusion Criteria:\n\n1. Aged ≥18 and ≤75 years.\n2. Diagnosed with cutaneous lupus erythematosus (CLE) for at least 3 months before the screening visit.\n3. Biopsy-proven histologically consistent with discoid lupus erythematosus (DLE) and\u002For subacute cutaneous lupus erythematosus (SCLE).\n4. CLASI activity (CLASI-A) score ≥8 at both the screening and baseline (Day 1) visits.\n5. May have concomitant systemic lupus erythematosus (SLE) or not.\n6. The treatment regimen is stable and can be maintained until the end of the study treatment.\n7. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the first dose on Day 1.\n8. Women of childbearing potential (WOCBP) and male subjects must agree to use highly effective contraceptive methods throughout the study treatment period and for one month (28 days) after the last dose\n\nExclusion Criteria:\n\n1. Specific cutaneous lupus erythematosus subtypes: acute cutaneous lupus erythematosus (ACLE), tumid lupus, lupus panniculitis (deep lupus), chilblain lupus.\n2. Patients with drug-induced cutaneous lupus erythematosus and\u002For drug-induced systemic lupus erythematosus.\n3. Subjects with active kidney disease 4．Other inflammatory joint or skin diseases or overlap syndrome not caused by systemic lupus erythematosus (SLE) as the primary disease.\n\n5\\. Other autoimmune diseases except for secondary Sjögren's syndrome. 6. Concurrent herpes zoster infection at screening or before dosing on Day 1, or a history of severe herpes zoster or severe herpes simplex infection.\n\n7\\. Positive Hepatitis B surface Antigen (HBsAg) at screening; or abnormal Hepatitis B Virus (HBV)Deoxyribonucleic Acid (DNA) Polymerase Chain Reaction (PCR) test result in subjects positive for Hepatitis B core Antibody (HBcAb).\n\n8 Evidence of active, latent, or inadequately treated mycobacterium tuberculosis (TB) infection.\n\n9.Previous or current use of other immunomodulatory or immunosuppressive treatments except for permitted background medications specified in the protocol.\n\n10\\. Inadequate organ function levels, including abnormalities in hematology, liver function, renal function, coagulation function, cardiac function, etc.",{"count":66,"type":22},105,[68],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).",[29],"2026-06-05",{"date":73,"type":49},"2026-06-08",{"date":75,"type":49},"2026-04-27",{"date":77,"type":22},"2027-12",{"name":79,"class":56},"Beijing InnoCare Pharma Tech Co., Ltd.",27,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100627972","phase-1-study-of-s-4321-in-participants-with-an-autoimmune-or-immune-mediated-disease-100627972","NCT07455578","Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease","Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease","All Participants Major Inclusion Criteria:\n\n1. Adult males and females, 18 to 75 years of age (inclusive)\n2. Body mass index (BMI) ≥18.0 and \\\u003C40.0 kg\u002Fm2 with a minimum body weight of 45 kg\n3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test.\n\nAll Participants Major Exclusion Criteria:\n\n1. Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy.\n2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks\n3. Unable or unwilling to discontinue a prohibited medication\n4. Presence of clinically relevant immunosuppression\n5. Current infection or history of severe infection\n6. Any history of malignant disease, with some exceptions\n\nMajor inclusion\u002Fexclusion for each autoimmune or immune-mediated disease:\n\nFor RA:\n\n1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010\u002FEuropean League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:\n\n   1. ≥6 swollen joint count based on 66 joint count\n   2. ≥6 tender joint count based on 68 joint count\n   3. Seropositive for RF and\u002For ACPA\n   4. Elevated hsCRP ≥1.2 times greater than the ULN\n   5. Does not have Class IV RA according to ACR revised criteria\n2. Inadequate response to, or loss of response, or intolerance to:\n\n   1. \\>1 conventional synthetic DMARD after 3 months of therapy OR\n   2. \\>1 biologic DMARD\u002Ftargeted synthetic DMARD after 3 months of therapy\n   3. Has not failed 3 or more bDMARDs and\u002For tsDMARDs\n\nFor PsA:\n\n1. Confirmed diagnosis of adult-onset PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 3 months prior to the Screening 1 visit, with all of the following:\n\n   1. Active PsO defined by at least 1 psoriasis lesion\n   2. Active disease defined by \\>3 swollen joints and \\>3 tender joints using the 76\u002F78 swollen and tender joint count\n2. Received standard doses of NSAIDs for \\>4 weeks or csDMARDs for \\>3 months and has been on a stable dose for \\>8 weeks, or participant has intolerance to NSAIDs or DMARDs\n3. Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor\n4. Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs\n\nFor PsO:\n\n1. Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following:\n\n   1. Psoriasis Area and Severity Index (PASI) \\>12 points\n   2. Static Physician's Global Assessment (sPGA) \\>3 points\n   3. Body surface area (BSA) of PsO involvement \\>10%\n2. Cannot have a clinically significant flare within 12 weeks\n3. Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis\n4. Has not had inadequate response to more than 2 prior bDMARDs\n\nFor CLE (with or without systemic manifestations):\n\n1. Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months\n2. Has active skin manifestations as measured by CLASI-A \\>10 or CLASI-A \\>8, if there is no alopecia or mucous membrane lesions\n3. Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months.\n4. Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR \\\u003C45 mL\u002Fmin\u002F1.73m2\n5. Cannot have active neuropsychiatric SLE\n\nFor AD:\n\n1. Confirmed diagnosis of AD as defined by the American Academy of Dermatology: Guidelines of Care for the Management of Atopic Dermatitis for at least 12 months\n\n   1. Eczema Area and Severity Index (EASI) \\>16\n   2. Validated Investigator Global Assessment (vIGA-AD) \\>3\n   3. BSA of AD involvement \\>10%\n   4. PP-NRS) \\>4 (average of daily scores) during the 7 days prior to dosing\n2. Inadequate response to existing topical medications within 6 months or has a history of intolerance to topical therapy as defined by at least 1 of the following:\n\n   1. Inability to achieve good disease control after use TCS for at least 4 weeks\n   2. Documented history of clinically significant AEs with the use of TCS\n   3. Failed systemic therapies intended to treat AD within 6 months\n\nAdditional inclusion\u002Fexclusion criteria will apply.",{"count":89,"type":22},24,[91],"PHASE1","This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).",[94,95,96,97,29,98],"Autoimmune Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Atopic Dermatitis (AD)",[100,101,102,103,104,98,97,96,29,105],"Autoimmune","Immune-mediated","S-4321","Seismic Therapeutic","Rheumatoid Arthritis","Cutaneous Lupus","2026-05-28",{"date":108,"type":49},"2026-06-01",{"date":110,"type":22},"2026-06",{"date":112,"type":22},"2027-09",{"name":114,"class":56},"Seismic Therapeutic AU Pty Ltd",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":80},"100612999","phase-2-a-multicenter-randomized-double-blind-placebo-controlled-phase-2a-study-with-an-open-label-extension-evaluating-the-efficacy-and-safety-of-vent-03-in-adult-participants-with-active-cutaneous-lupus-erythematosus-with-or-without-systemic-lupus-erythematosus-100612999","NCT07260877","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus","AERIS","Key Inclusion Criteria:\n\n* Cutaneous lupus:\n\n  * CLASI-A score ≥8;\n  * At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion\n* If participant has previous SLE diagnosis:\n\n  * Positive antinuclear antibody test at Screening by immunofluorescent assay at the central laboratory with titer ≥ 1:80;\n  * Meets the American College of Rheumatology\u002F European Alliance of Associations for Rheumatology 2019 criteria for SLE; and\n  * Currently receiving at least one of the specified SLE medication treatments, at stable doses.\n\nKey Exclusion Criteria:\n\n* Meet protocol-specified infection or lab criteria; any other laboratory test results that, in the investigator's opinion, might place participant at unacceptable risk for participating in this study;\n* Moderate or severe liver impairment as classified by the Child-Pugh criteria (categories B and C);\n* Has drug-induced lupus, rather than 'idiopathic' lupus;\n* History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus;\n* Diagnosis of select potentially confounding autoimmune disorders\n* Active severe or unstable neuropsychiatric SLE;\n* Hospitalization for a severe lupus flare in the past 3 months, or active severe SLE-driven disease, including lupus nephritis, for which in the opinion of the PI the protocol-specified SOC is insufficient;\n* History of or current diagnosis of anti-phospholipid syndrome;\n* History of any non-lupus 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 Day 1;\n* Meets protocol specified medical history of infectious diseases and infections and\u002For opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within specified timeframes;\n* Cancer screening results suspicious of malignancy or history of cancer within time specified with exceptions for curative therapy for squamous or basil cell carcinoma and cervical cancer in situ; and\n* Meets protocol specified exclusions related to concomitant medications.","80 Years",{"count":89,"type":22},[68],"The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are:\n\n* Does VENT-03 affect the activity and severity of CLE?\n* What side effects do participants have when taking VENT-03?\n\nResearchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE.\n\nParticipants will:\n\n* Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks;\n* Visit the clinic once a month for checkups and tests.",[29,128,34,129,35],"Systemic Lupus Erythematosus","SLE (Systemic Lupus)",[131,132],"CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03","cGAS","2026-03-30",{"date":135,"type":49},"2026-04-06",{"date":137,"type":49},"2025-12-03",{"date":139,"type":22},"2026-09",{"name":141,"class":56},"Ventus Therapeutics U.S., Inc.",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":115},"100171798","prevalence-and-clinical-severity-of-cutaneous-lupus-erythematosus-100171798","NCT01510067","Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus","Inclusion Criteria:\n\n* Subjects who meet the criteria for having CLE, using the Gilliam classifications, and\u002For a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association\u002FAmerican College of Rheumatology criteria. Subjects must be 18 years or older.\n\nExclusion Criteria:\n\n* All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old",{"count":149,"type":22},700,"OBSERVATIONAL","The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).",[29],[35,36,154],"Lupus Erythematosus","2026-03-24",{"date":133,"type":49},{"date":158,"type":4},"2006-12",{"date":160,"type":22},"2030-01-02",{"name":162,"class":163},"University of Pennsylvania","OTHER",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100616513","phase-1-the-safety-tolerability-pharmacokinetics-immunogenicity-and-preliminary-efficacy-of-hc022-injection-in-subjects-with-slecle-100616513","NCT07306585","The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE\u002FCLE","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity Characteristics and Preliminary Efficacy of Multiple Ascending Doses of HC022 Injection in Subjects With Systemic Lupus Erythematosus and\u002For Cutaneous Lupus Erythematosus","Inclusion Criteria:\n\n* 1\\. Subjects who voluntarily participate in the study, are able to sign the informed consent form and comply with the requirements on the informed consent form;\n* 2\\. Age ≥ 18 years, regardless of gender;\n* 3\\. Subjects and their partners have no birth plan during the study treatment period and within 6 months after the last dose, and voluntarily use effective and reliable contraception (Attachment 1). Female subjects must have a negative serum pregnancy test and be non-lactating;\n* 4\\. Patients diagnosed with SLE or CLE by the investigator\n\nExclusion Criteria:\n\n* 1\\. active severe lupus nephritis\n* 2\\. active neuropsychiatric SLE\n* 3 .History or current diagnosis of any other systemic autoimmune disease other than secondary Sjogren's syndrome, including but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant non-SLE related vasculitis;\n* 4\\. Drug-induced lupus;\n* 5\\. HIV medical history or positive test results, treponema pallidum antibody positive, hepatitis B infection (HBsAg or HBcAb positive), hepatitis C infection (HCV antibody positive and quantitative abnormality), cytomegalovirus infection (IgM positive and quantitative abnormality) and Epstein-Barr virus infection (IgM positive and quantitative abnormality);\n* 6.History of tuberculosis infection, or evidence of active or latent mycobacterium tuberculosis infection at the time of signing informed consent;\n* 7\\. The following laboratory abnormalities were present, including but not limited to: a) Subjects with abnormal liver function: e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2 times the upper limit of normal (ULN), or total bilirubin \\> 1.5 × ULN (except for those due to Gilbert syndrome); or b) Subjects with abnormal hematology: Hemoglobin \\\u003C 90 g\u002FL, or platelet count \\\u003C 75 x 109\u002FL, or absolute neutrophil count \\\u003C 1.5 x 109\u002FL;\n* 8\\. Subjects with a history of chronic, recurrent (3 or more infections of the same type within 1 year) or severe infections (e.g. pneumonia and sepsis) within half a year before informed consent as determined by the investigator, including viral infection, or requiring systemic anti-infective treatment within 12 weeks before informed consent;\n* 9.History of severe herpes infection (e.g., herpetic encephalitis, ocular herpes or diffuse herpes) or signs of herpes or varicella-zoster virus infection within 12 weeks prior to knowledge (especially chickenpox and herpes zoster);\n* 10\\. History or current history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical cancer in situ that have been completely removed and considered cured \\> 2 years at the time of informed consent).\n* 11\\. New York Heart Association Functional Class III or IV congestive heart failure\n* 12\\. Subjects with informed consent or abnormal and clinically significant ECG results before administration\n* 13.Patients with suicidal behavior or thoughts within 1 year before informed consent;\n* 14.Subjects with a history of drug abuse within 12 months before informed consent, or positive baseline urine drug test results;\n* 15\\. Use the prohibited drugs stipulated in the plan\n* 16\\. Antimalarials were started within 12 weeks prior to randomization, and subjects must have been on a stable dose from screening through the end of study (only for CLE patients) if they were receiving antimalarial treatment at screening;\n* 17\\. Treatment with oral systemic corticosteroids at doses greater than 15 mg\u002Fday prednisone (or its equivalent) prior to randomization (only for patients with CLE);\n* 18\\. Patients who have previously received drugs that inhibit BDCA2 targets;\n* 19\\. Subjects who have participated in other clinical trials within 4 weeks before informed consent, or within 5 half-lives of the investigational drug, whichever is longer;\n* 20\\. Presence of a past or present condition other than SLE and\u002For CLE that, in the opinion of the Investigator, may interfere with the assessment of skin inflammation and disease activity;\n* 21\\. Subjects who are allergic to the investigational drug (including excipients) or suffer from serious allergic diseases or have an allergic constitution (such as allergy to two or more drugs, food or pollen), which may impair the safety of subjects in the judgment of the investigator;\n* 22\\. Tattoos, scars or other physical examination findings in the area of planned injection sites that interfere with local injection site evaluation;\n* 23\\. Live vaccine or live attenuated vaccine within 4 weeks before informed consent, or planned during the study and within 24 weeks after the last dose of study drug;\n* 24\\. Subjects with a blood donation volume ≥ 500 mL within 4 weeks before informed consent or planned during the study, or have a history of blood transfusion within 4 weeks before informed consent;\n* 25\\. Subjects with an average daily alcohol intake of more than 2 units (1 unit of alcohol ≈ 360 mL of beer containing 5% alcohol or 45 mL of spirits containing 40% alcohol or 150 mL of wine containing 12% alcohol) within 3 months before informed consent, or subjects with positive baseline alcohol breath test;\n* 26\\. Other reasons that the investigator considers unsuitable for participation in this study.",{"count":172,"type":22},32,[91],"The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE\u002FCLE subjects. Secondary objectives of study are as follows: To estimate the PK parameters of multiple-ascending SC doses of HC022 in SLE\u002FCLE subjects；To evaluate the immunogenicity of HC022 administered to SLE\u002FCLE subjects.",[28,29],"NOT_YET_RECRUITING","2026-01-26",{"date":179,"type":49},"2026-01-28",{"date":181,"type":22},"2025-12-30",{"date":183,"type":22},"2027-09-24",{"name":185,"class":56},"HC Biopharma Inc.",1,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":195,"targetDuration":197,"studyType":150,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":186},"100587348","research-accelerated-by-you-lupus-registry-100587348","NCT06927219","Research Accelerated by You Lupus Registry","Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry","RAY","Inclusion Criteria:\n\n* For adults with lupus, the individual who completes the Registry:\n\n  * is 18 years of age or older\n  * has a self-reported diagnosis of lupus by a physician or health care provider\n  * is willing and able to provide informed consent\n  * is able to read and understand English sufficiently to complete the survey questions\n  * has access to a computer with an internet connection\n\nFor children under 18 with lupus, the individual who completes the Registry is:\n\n* 18 years of age or older\n* the parent\u002Flegal guardian\u002Flegally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider\n* willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age\n* able to access a computer with an internet connection\n* able to read and understand English sufficiently to complete the survey questions\n\nFor adults with lupus unable to provide consent, the individual who completes the Registry is:\n\n* 18 years of age or older\n* the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider\n* willing and able to provide consent for the adult with lupus\n* able to access a computer with an internet connection\n* able to read and understand English sufficiently to complete the survey questions\n\nExclusion Criteria:\n\n* People who are not living with lupus",{"count":196,"type":22},10000,"10 Years","Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease.\n\nRemote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access.\n\nParticipation Details\n\nConsent: Informed consent is completed electronically.\n\nSurveys: Participants complete electronic surveys upon enrollment and every six months thereafter.\n\nData Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life.\n\nPurpose and Data Use The LFA uses registry data to:\n\nAddress Constituent Needs: Inform programs and resources for the lupus community.\n\nAdvance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus.\n\nPatient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.",[28,200,29],"Lupus Nephritis (LN)",[202,203],"lupus","registry","2026-01-22",{"date":206,"type":49},"2026-01-23",{"date":208,"type":49},"2020-10-01",{"date":210,"type":22},"2050-12-31",{"name":212,"class":163},"Lupus Foundation of America",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":176,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100590271","phase-3-lenalidomide-vs-methotrexate-in-difficult-to-treat-cutaneous-lupus-erythematosus-100590271","NCT06965244","Lenalidomide vs Methotrexate in Difficult-to-treat Cutaneous Lupus Erythematosus","Lenalidomide vs mEthotrexate in dIfficult-to-treat cutaneouS lUpus eRythEmatosus : An Assessor-blinded Randomized Clinical Trial","LEISURE","Inclusion Criteria:\n\n1. Patients of at least 18 years of age\n2. Affiliated to the French social security\n3. Able to provide written informed consent\n4. Histologically-confirmed diagnosis of active CLE with or without associated SLE, either historical or at screening\n5. CLASI-A score ≥ 8 at both screening and randomization\n6. Active CLE despite\n\n   * AMs agents used for at least 3 months and at stable dose for at least 30 days prior to randomization or previously documented discontinuation of AMs due to poor tolerability an\u002For side effect and\u002For\n   * stable dose of GCs ≤15mg\u002Fday and\u002For\n   * stable dose of topical corticosteroids (TCS) or topical tacrolimus for at least 30 days prior to randomization\n7. Accepting monthly plasma pregnancy test and using adequate contraception for at least 4 weeks before and until 4 weeks following treatment\n\nExclusion Criteria:\n\n1. Kidney function, liver function, cell blood count and infectious serology incompatible with receiving the study treatments, according to the SMPC of each drug.\n2. Alcoholism (1\u002F no more than 10 standard drinks per week, 2\u002F no more than two standard drinks per day, and 3\u002F at least two alcohol-free days every week)\n3. Ongoing cancer, including solid tumors and hematologic malignancies\n4. Active severe SLE features including lupus nephritis, neuropsychiatric SLE, serositis, severe haematological features (autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) requiring high dose oral or IV GC and\u002For mycophenolate mofetil or cyclophosphamide\n5. Medications:\n\n   * Previous failure of methotrexate and lenalidomide prescribed for active CLE\n   * Use of classical immunosuppressant drugs (mycophenolate mofetil, azathioprine), thalidomide, dapsone, retinoids, Janus Kinase inhibitors for CLE or SLE 4 weeks before screening\n   * Use of biological therapy for CLE or SLE (including belimumab, rituximab, obinituzumab, ustekinumab, anifrolumab) 12 weeks before screening\n6. Contraindication to use low-dose aspirin: salicylate hypersensitivity, salicylate-induced asthma, constitutional or acquired bleeding disorder, active gastroduodenal ulcer, or history of digestive bleeding.\n7. Arterial or unprovoked venous thromboembolic events ≤ 5 years (for note antiphospholipid syndrome treated with vitamin K antagonist without thromboembolic events in the last 5 years or patients with positive antiphospholipid autoantibodies will NOT be excluded)\n8. Pregnant women, breastfeeding or planning to become pregnant during the study treatment period and 1 month after the last dose of study treatment\n9. Patients under legal protection and inability to comply with study requirement",{"count":222,"type":22},122,[25],"Cutaneous lupus erythematosus (CLE) is a heterogeneous inflammatory autoimmune disease associated or not with systemic lupus erythematosus (SLE). Active CLE often cause pain\u002Fburning sensation and may lead to permanent visible scars and cicatricial alopecia, with psycho-social consequences\u002Fpoor quality of life. First-line antimalarials (AMs) are recommended in CLE in addition to topical corticosteroids\u002Ftacrolimus with long-term response rate around 50%. Oral glucocorticosteroids (GCs) are recommended in addition to AMs for short term therapy in severe or widespread active CLE lesions. In non-responders to AMs and low-dose oral GCs, i.e., difficult-to-treat CLE, guidelines recommend the add-on of methotrexate as preferential second-line agent, with an overall efficacy of 50% in observational studies. Thalidomide has shown response rate of ≈90% in CLE in a meta-analysis of observational studies and is recommended as a second or third-line agent. However, potential severe adverse events (AEs) including teratogenicity, peripheral neuropathy and thromboembolic events limit its use.\n\nBiological therapies including belimumab and anifrolumab, are approved only for patients with associated SLE (and not for those with isolated CLE). Their efficacy has been demonstrated as add-on therapy versus placebo but not versus a comparative drug. Moreover, efficacy of belimumab seems limited in difficult to-treat CLE and has not been assessed using validated tool, as the Cutaneous Lupus Erythematosus Disease Area and Severity (CLASI) Index. Anifrolumab seems interesting in CLE associated with SLE, but its use is limited by monthly intravenous infusions, high cost and unknown long-term AEs. Moreover, its efficacy in isolated CLE has not been assessed.\n\nLenalidomide is a thalidomide analogue with in vitro 1000 more potent immunomodulatory properties. It is recommended as a third-line treatment in France. With more than 60 treated patients, it showed excellent and rapid efficacy with an absence of drowsiness and peripheral neuropathy with a low-dose regimen of 5 mg\u002Fday. The use of lenalidomide was to date limited by its very high cost and its indications were restricted to haematological disorders. For note, the prevention of the higher risk of thromboembolism with lenalidomide requires the daily use of low-dose aspirin.\n\nIn France, a generic of lenalidomide is now available with a monthly cost of 2 euros, allowing a broad-scale assessment of its efficacy. Finally, lenalidomide might have a better efficacy than methotrexate.\n\nWe hypothesize that lenalidomide would be more efficacious than methotrexate in difficult-to-treat CLE patients with or without associated SLE. We assume that such trial would not be supported by pharmaceutical companies.",[29],[227,228,229,230,231,232],"systemic lupus erythematosus","cutaneous lupus erythematosus","chronic CLE","lenalidomide","methotrexate","Resistance to anti-malarial","2025-05-07",{"date":235,"type":49},"2025-05-11",{"date":237,"type":22},"2025-10-01",{"date":239,"type":22},"2029-04-01",{"name":241,"class":163},"Assistance Publique - Hôpitaux de Paris"]