A Phase 2 interventional study of Repository Corticotropin Injection (ACTH) and Study-matched inactive placebo injection, also called control injection in Behçet's Syndrome and Behçet's Syndrome (BS), sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
136 studies on the registry are indexed under Behcet Syndrome; 42 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 70 interventional studies indexed under Behcet Syndrome.
Browse Behcet Syndrome studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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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.
Present with active oral ulcers, defined as no less than 2 definite active oral ulcers at screening.
Voluntarily participate in this study, sign the written form, and be capable of completing all scheduled follow-up visits and examinations throughout the trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Repository Corticotropin Injection (ACTH)
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.
Drug: Study-matched inactive placebo injection, also called control injection
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.
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.
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.
Time frame: Baseline (Week 0) and Week 12
Change in Behçet's disease mucosal lesion score from baseline at week 12
Time frame: Baseline, Week 12
Change in disease activity score
Time frame: From baseline up to Week 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.
Time frame: Baseline (Week 0), Week 12
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.
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12
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.
Time frame: Baseline (Week 0), Week 12
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.
Time frame: Baseline (Week 0), Week 12
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.
Time frame: Randomization until Week 24
Plan to share: No — Individual participant data will not be shared with external researchers to protect participant privacy and comply with institutional data management regulations. Only aggregated summary results will be published.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adrenocorticotropic Hormone
Peking University People's Hospital →