[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07260877":3,"trial-entities:NCT07260877":299,"trial-summary:NCT07260877":304},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":48,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":14,"eligibility_criteria":73,"std_ages":96,"locations":99,"central_contacts":290,"overall_officials":296,"references":297,"see_also_links":298},"NCT07260877","VENT-03-201","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","RECRUITING","2026-09","2026-01","2026-07-27","2025-12-03","Ventus Therapeutics U.S., Inc.","INDUSTRY",false,"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.",null,[18,19,20,21,22],"Cutaneous Lupus Erythematosus (CLE)","Systemic Lupus Erythematosus","SLE","SLE (Systemic Lupus)","CLE",[24,25],"CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03","cGAS","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},24,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","VENT-03","VENT-03 is a tablet",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo is a tablet",[40],[44],{"measure":45,"description":46,"timeFrame":47},"Evaluate the effect of VENT-03 on the interferon gene signature in the skin","Percent change from baseline in interferon gene signature in the skin at Day 28","Baseline to End of Double-Blind Treatment (up to Day 28)",[49,52,55,58,61,63,65,68],{"measure":50,"description":51,"timeFrame":47},"Evaluate the effect of VENT-03 on CLE disease severity","Percent change from baseline in CLASI-A score at Day 28",{"measure":53,"description":54,"timeFrame":47},"Evaluate effect of VENT-03 on CLE disease severity","Percentage of participants achieving CLASI-A 50 response (≥ 50% improvement in CLASI A score compared with baseline) at Day 28",{"measure":56,"timeFrame":57},"Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy","Baseline to End of Treatment (up to Day 84)",{"measure":59,"description":60,"timeFrame":57},"Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and\u002For Serious Adverse Event (SAE)","An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability\u002Fincapacity; congenital anomaly.",{"measure":62,"timeFrame":57},"Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)",{"measure":64,"timeFrame":57},"Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation",{"measure":66,"timeFrame":67},"Cmax: Maximum Observed Plasma Concentration for VENT-03","Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose",{"measure":69,"timeFrame":67},"AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for VENT-03","ALL","18 Years","80 Years",{"inclusion":74,"exclusion":82,"raw_text":95},[75,76,77,78,79,80,81],"Cutaneous lupus:","CLASI-A score ≥8;","At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion","If participant has previous SLE diagnosis:","Positive antinuclear antibody test at Screening by immunofluorescent assay at the central laboratory with titer ≥ 1:80;","Meets the American College of Rheumatology\u002F European Alliance of Associations for Rheumatology 2019 criteria for SLE; and","Currently receiving at least one of the specified SLE medication treatments, at stable doses.",[83,84,85,86,87,88,89,90,91,92,93,94],"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;","Moderate or severe liver impairment as classified by the Child-Pugh criteria (categories B and C);","Has drug-induced lupus, rather than 'idiopathic' lupus;","History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus;","Diagnosis of select potentially confounding autoimmune disorders","Active severe or unstable neuropsychiatric SLE;","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;","History of or current diagnosis of anti-phospholipid syndrome;","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;","Meets protocol specified medical history of infectious diseases and infections and\u002For opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within specified timeframes;","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","Meets protocol specified exclusions related to concomitant medications.","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.",[97,98],"ADULT","OLDER_ADULT",[100,109,116,122,128,135,142,148,155,162,169,176,182,188,194,199,204,210,215,221,227,233,238,243,248,253,258,263,269,274,279,285],{"facility":101,"status":7,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"Investigative Site","Beverly Hills","California","90211","United States",{"lat":107,"lon":108},34.07362,-118.40036,{"facility":101,"status":7,"city":110,"state":111,"zip":112,"country":105,"geoPoint":113},"Clearwater","Florida","33765",{"lat":114,"lon":115},27.96585,-82.8001,{"facility":101,"status":7,"city":117,"state":111,"zip":118,"country":105,"geoPoint":119},"DeBary","32713",{"lat":120,"lon":121},28.88305,-81.30868,{"facility":101,"status":7,"city":123,"state":111,"zip":124,"country":105,"geoPoint":125},"Tampa","33606",{"lat":126,"lon":127},27.94752,-82.45843,{"facility":101,"status":7,"city":129,"state":130,"zip":131,"country":105,"geoPoint":132},"Indianapolis","Indiana","46250",{"lat":133,"lon":134},39.76838,-86.15804,{"facility":101,"status":7,"city":136,"state":137,"zip":138,"country":105,"geoPoint":139},"Flint","Michigan","48439",{"lat":140,"lon":141},43.01253,-83.68746,{"facility":101,"status":7,"city":143,"state":137,"zip":144,"country":105,"geoPoint":145},"Troy","48084",{"lat":146,"lon":147},42.60559,-83.14993,{"facility":101,"status":7,"city":149,"state":150,"zip":151,"country":105,"geoPoint":152},"Saint Joseph","Missouri","64506",{"lat":153,"lon":154},39.76861,-94.84663,{"facility":101,"status":7,"city":156,"state":157,"zip":158,"country":105,"geoPoint":159},"Fairport","New York","14450",{"lat":160,"lon":161},43.09867,-77.44194,{"facility":101,"status":7,"city":163,"state":164,"zip":165,"country":105,"geoPoint":166},"Memphis","Tennessee","38119",{"lat":167,"lon":168},35.14953,-90.04898,{"facility":101,"status":7,"city":170,"state":171,"zip":172,"country":105,"geoPoint":173},"Allen","Texas","75013",{"lat":174,"lon":175},33.10317,-96.67055,{"facility":101,"status":7,"city":177,"state":171,"zip":178,"country":105,"geoPoint":179},"Arlington","76012",{"lat":180,"lon":181},32.73569,-97.10807,{"facility":101,"status":7,"city":183,"state":171,"zip":184,"country":105,"geoPoint":185},"Colleyville","76034",{"lat":186,"lon":187},32.88096,-97.15501,{"facility":101,"status":7,"city":189,"country":190,"geoPoint":191},"Haskovo","Bulgaria",{"lat":192,"lon":193},41.93415,25.55557,{"facility":101,"status":7,"city":195,"country":190,"geoPoint":196},"Plovdiv",{"lat":197,"lon":198},42.15387,24.75001,{"facility":101,"status":7,"city":200,"country":190,"geoPoint":201},"Sofia",{"lat":202,"lon":203},42.69751,23.32415,{"facility":101,"status":7,"city":205,"country":206,"geoPoint":207},"Paris","France",{"lat":208,"lon":209},48.85341,2.3488,{"facility":101,"status":7,"city":211,"country":206,"geoPoint":212},"Toulouse",{"lat":213,"lon":214},43.60426,1.44367,{"facility":101,"status":7,"city":216,"country":217,"geoPoint":218},"Tbilisi","Georgia",{"lat":219,"lon":220},41.69143,44.83412,{"facility":101,"status":7,"city":222,"country":223,"geoPoint":224},"Szeged","Hungary",{"lat":225,"lon":226},46.253,20.14824,{"facility":101,"status":7,"city":228,"country":229,"geoPoint":230},"Bialystok","Poland",{"lat":231,"lon":232},53.13333,23.16433,{"facility":101,"status":7,"city":234,"country":229,"geoPoint":235},"Oświęcim",{"lat":236,"lon":237},50.03437,19.21037,{"facility":101,"status":7,"city":239,"country":229,"geoPoint":240},"Poznan",{"lat":241,"lon":242},52.40692,16.92993,{"facility":101,"status":7,"city":244,"country":229,"geoPoint":245},"Rzeszów",{"lat":246,"lon":247},50.04132,21.99901,{"facility":101,"status":7,"city":249,"country":229,"geoPoint":250},"Śląskie",{"lat":251,"lon":252},51.93249,15.55553,{"facility":101,"status":7,"city":254,"country":229,"geoPoint":255},"Warsaw",{"lat":256,"lon":257},52.22977,21.01178,{"facility":101,"status":7,"city":259,"country":229,"geoPoint":260},"Wroclaw",{"lat":261,"lon":262},51.10286,17.03006,{"facility":101,"status":7,"city":264,"country":265,"geoPoint":266},"Durban","South Africa",{"lat":267,"lon":268},-29.8579,31.0292,{"facility":101,"status":7,"city":270,"country":265,"geoPoint":271},"Pretoria",{"lat":272,"lon":273},-25.74486,28.18783,{"facility":101,"status":7,"city":275,"country":265,"geoPoint":276},"Somerset West",{"lat":277,"lon":278},-34.08401,18.82113,{"facility":101,"status":7,"city":280,"country":281,"geoPoint":282},"Badajoz","Spain",{"lat":283,"lon":284},38.87789,-6.97061,{"facility":101,"status":7,"city":286,"country":281,"geoPoint":287},"Madrid",{"lat":288,"lon":289},40.4165,-3.70256,[291],{"name":292,"role":293,"phone":294,"email":295},"Krista Miller","CONTACT","913-410-2156","AERIS@iconplc.com",[],[],[],{"nct_id":4,"conditions":300,"biomarkers":302},[301,19],"Cutaneous Lupus Erythematosus",[303],"Antinuclear Antibody",{"nct_id":4,"found":305,"summary":306,"prompt_version":316},true,{"design":307,"status":308,"heading":309,"summary":310,"follow_up":311,"word_count":312,"commitments":313,"compensation":314,"drugs_mentioned":315},"This is a randomized, double-blind (meaning neither you nor your doctor will know if you're getting VENT-03 or placebo), placebo-controlled study with an open-label extension, involving about 24 adult participants.","completed","VENT-03 for Cutaneous Lupus Erythematosus","This study is testing a new tablet called VENT-03 for adults with cutaneous lupus erythematosus (CLE), a skin condition, who may or may not also have systemic lupus erythematosus (SLE). Researchers want to see if VENT-03 can improve CLE symptoms and if it is safe. You would take either VENT-03 or a placebo (a tablet with no medicine) for 4 weeks, then all participants would take VENT-03 for another 8 weeks. The main way success will be measured is by looking at how VENT-03 affects certain genetic markers in your skin. This study is currently recruiting about 24 participants.","The primary endpoint evaluates the effect of VENT-03 up to Day 28.",99,"You would take VENT-03 or a placebo for 4 weeks, then VENT-03 for another 8 weeks. You would also visit the clinic once a month for checkups and tests.","Not stated in the trial record.",[36,40],"v2"]