[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657062":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":15,"studyPopulation":15,"armGroups":52,"interventions":65,"overallOfficials":15,"centralContacts":75,"locations":82,"responsibleParty":103,"collaborators":15,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":15,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":15,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":15,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":35},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in the number of active oral aphthous ulcers from baseline to Week 12","The primary efficacy endpoint is the change in count of active painful oral aphthous ulcers in patients with Behçet's syndrome, comparing the difference of ulcer quantity between baseline screening visit and the end of 12-week intervention period, to evaluate the therapeutic effect of ACTH on mucosal lesions.","Baseline (Week 0) and Week 12",{"measure":14,"description":15,"timeFrame":16},"Change in Behçet's disease mucosal lesion score from baseline at week 12",null,"Baseline, Week 12",[18,21,25,29,32],{"measure":19,"description":15,"timeFrame":20},"Change in disease activity score","From baseline up to Week 24",{"measure":22,"description":23,"timeFrame":24},"Change in number of active genital ulcers from baseline to Week 12","Compare the change in active genital ulcer count of Behçet's syndrome patients between baseline and Week 12 intervention endpoint, to evaluate the efficacy of ACTH on genital mucosal lesions.","Baseline (Week 0), Week 12",{"measure":26,"description":27,"timeFrame":28},"Change in visual analog scale (VAS) pain score of oral ulcers from baseline to Week 12","Oral ulcer pain intensity is assessed using a 0-10 visual analog scale (VAS). Calculate the score change from baseline to Week 12 to compare pain relief effect between two groups.","Baseline (Week 0), Week 4, Week 8, Week 12",{"measure":30,"description":31,"timeFrame":24},"Change in Behçet's Disease Current Activity Form (BDCAF) and Behçet Syndrome Activity Score (BSAS) from baseline to Week 12","Evaluate overall disease activity via BDCAF and BSAS at baseline and Week 12; compare the score variation between two groups to assess the systemic disease activity control effect of ACTH.",{"measure":33,"description":34,"timeFrame":24},"Change in 36-Item Short Form Health Survey (SF-36) total score from baseline to Week 12","Total SF-36 score reflecting physical, psychological and social function is collected at baseline and Week 12. Higher score indicates better quality of life; intergroup score change is compared.",[36],{"measure":37,"description":38,"timeFrame":39},"Incidence, severity and relatedness of adverse events (AEs) and serious adverse events (SAEs) throughout the 24-week trial period","All adverse events including elevated blood glucose, electrolyte disturbance, hypertension, injection site reaction, infection, hypersensitivity and other unexpected adverse reactions are continuously recorded from randomization to Week 24. The frequency, severity grade, causal relationship with study intervention and corresponding management are summarized to assess the overall safety and tolerability profile of repository corticotropin injection.","Randomization until Week 24",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":15,"timePerspective":15,"maskingInfo":45},"RANDOMIZED","PARALLEL","Two-arm parallel-group randomized double-blind placebo-controlled design. Subjects are randomized 1:1 to ACTH or identical placebo for 12 weeks of twice-weekly intramuscular treatment without crossover. A further 12-week post-treatment follow-up is conducted to evaluate long-term efficacy and safety. All participants and study assessors are kept blinded to treatment assignment during the entire trial","TREATMENT",{"masking":46,"maskingDescription":15,"whoMasked":47},"QUADRUPLE",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"ACTH Treatment Group","EXPERIMENTAL","Participants receive repository corticotropin injection (ACTH) 25 IU via intramuscular injection twice weekly for 12 consecutive weeks. No additional glucocorticoids, immunosuppressants or other drugs interfering with study efficacy assessment are permitted during the treatment period. After completing the 12-week intervention, subjects enter a 12-week off-treatment follow-up phase for efficacy and safety observation.",[58],"Drug: Repository Corticotropin Injection (ACTH)",{"label":60,"type":61,"description":62,"interventionNames":63},"Placebo Control Group","PLACEBO_COMPARATOR","Participants will receive physiologically inactive placebo injection, with identical appearance, injection route, administration frequency and treatment duration as the ACTH intervention arm. Injections are given intramuscularly twice weekly for 12 consecutive weeks, with identical restrictions on prohibited concomitant medications. Subjects will also complete a 12-week off-treatment observational follow-up after the intervention period ends.",[64],"Drug: Study-matched inactive placebo injection, also called control injection",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":15},"DRUG","Repository Corticotropin Injection (ACTH)","Participants receive repository corticotropin injection 25 IU via intramuscular injection twice weekly for 12 consecutive weeks. Concomitant systemic glucocorticoids, immunosuppressants and other drugs that may interfere with efficacy assessment are forbidden during treatment. After the 12-week intervention period, participants enter a 12-week treatment-free follow-up phase for sustained efficacy and safety evaluation.",[54],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":15},"Study-matched inactive placebo injection, also called control injection","Participants receive physiologically inert placebo injection identical in appearance, administration route, frequency and treatment duration to ACTH. Injections are administered intramuscularly twice weekly for 12 weeks, with identical prohibited concomitant medication rules as the experimental arm. All subjects complete a subsequent 12-week off-treatment observational follow-up after intervention ends.",[60],[76],{"name":77,"role":78,"phone":79,"phoneExt":80,"email":81},"Tian T Liu Tian T Liu","CONTACT","• +86 136 6134 5637","Xiaoxin X Gong","liutian03973@pku.edu.cn",[83],{"facility":84,"status":15,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Department of Rheumatology and Immunology, Peking University People's Hospital","Beijing","Beijing Municipality","100032","China","CN",{"type":91,"coordinates":92},"Point",[93,94],116.39723,39.9075,{"lat":94,"lon":93},[97,100],{"name":98,"role":78,"phone":99,"phoneExt":15,"email":81},"Tian Liu","+86 136 6134 5637",{"name":101,"role":78,"phone":102,"phoneExt":15,"email":15},"Xiaoxin Gong","+86 151 2814 5159",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"PRINCIPAL_INVESTIGATOR","Liu Tian","Associate Professor","100657062","phase-2-corticotropin-for-behets-disease-a-multicenter-randomized-controlled-trialacronym-100657062",false,"NCT07833163","Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.","A Multicenter Randomized Controlled Trial of Corticotropin for the Treatment of Behçet's Disease","Aged between 18 and 65 years, no restriction on gender. Meet the 1990 International Study Group (ISG) classification criteria for Behçet's disease, with a confirmed diagnosis for at least 3 months prior to screening enrollment.\n\nPresent with active oral ulcers, defined as no less than 2 definite active oral ulcers at screening.\n\nVoluntarily participate in this study, sign the written informed consent form, and be capable of completing all scheduled follow-up visits and examinations throughout the trial.","ALL","18 Years","65 Years",{"count":118,"type":119},60,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","Adrenocorticotropic hormone (ACTH) is a polypeptide hormone secreted by the anterior pituitary gland. It can stimulate adrenal cortical hyperplasia and the secretion of glucocorticoids, thereby exerting anti-inflammatory, immunosuppressive and anti-allergic effects. Its mechanism of action differs from direct administration of glucocorticoids; it may exert milder modulatory effects on the immune system and reduce adverse reactions induced by long-term glucocorticoid use. Clinically, ACTH has been applied in the treatment of autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis. Nevertheless, sufficient randomized controlled trials are lacking to verify its efficacy and safety for mucosal involvement in Behçet's syndrome. Accordingly, this clinical trial aims to evaluate the efficacy and safety of ACTH in treating mucosal lesions associated with Behçet's syndrome, so as to provide evidence for its rational clinical application.",[125,126],"Behçet's Syndrome","Behçet's Syndrome (BS)",[128,129,130,131],"Behçet's syndrome","Corticotropin","mucosal lesions","immune-inflammatory mechanism","NOT_YET_RECRUITING","2026-09-16",{"date":135,"type":136},"2026-09-22","ACTUAL",{"date":138,"type":119},"2026-09",{"date":140,"type":119},"2029-09",{"name":5,"class":6},1]