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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China
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
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