[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cle":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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",false,"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.","ALL","18 Years","80 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29,30,31],"Cutaneous Lupus Erythematosus (CLE)","Systemic Lupus Erythematosus","SLE","SLE (Systemic Lupus)","CLE",[33,34],"CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03","cGAS","RECRUITING","2026-03-30",{"date":38,"type":39},"2026-04-06","ACTUAL",{"date":41,"type":39},"2025-12-03",{"date":43,"type":21},"2026-09",{"name":45,"class":46},"Ventus Therapeutics U.S., Inc.","INDUSTRY",27]