Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07833163

Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Behçet's Syndrome Behcet Syndrome Behçet's Syndrome (BS) Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Panuveitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent form, and be capable of completing all scheduled follow-up visits and examinations throughout the trial.

Treatment and study plan

Repository Corticotropin Injection (ACTH)

Drug

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.

Study-matched inactive placebo injection, also called control injection

Drug

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.

Primary outcomes

  1. Change in the number of active oral aphthous ulcers from baseline to Week 12

    Time frame: Baseline (Week 0) and 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.

  2. Change in Behçet's disease mucosal lesion score from baseline at week 12

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Change in disease activity score

    Time frame: From baseline up to Week 24

  2. Change in number of active genital ulcers from baseline to Week 12

    Time frame: Baseline (Week 0), 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.

  3. Change in visual analog scale (VAS) pain score of oral ulcers from baseline to Week 12

    Time frame: Baseline (Week 0), Week 4, Week 8, 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.

  4. Change in Behçet's Disease Current Activity Form (BDCAF) and Behçet Syndrome Activity Score (BSAS) from baseline to Week 12

    Time frame: Baseline (Week 0), 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.

  5. Change in 36-Item Short Form Health Survey (SF-36) total score from baseline to Week 12

    Time frame: Baseline (Week 0), 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.

Other outcomes

  1. Incidence, severity and relatedness of adverse events (AEs) and serious adverse events (SAEs) throughout the 24-week trial period

    Time frame: Randomization until Week 24

    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.

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Multicenter Randomized Controlled Trial of Corticotropin for the Treatment of Behçet's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.