Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Repository Corticotropin Injection (ACTH)
DrugParticipants 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
DrugParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ACTH Treatment GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 122
Change in Behçet's disease mucosal lesion score from baseline at week 12
Time frame
Baseline, Week 12Secondary outcomes
1
Change in disease activity score
Time frame
From baseline up to Week 242
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 123
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 124
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 12Other outcomes
1
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 24Sponsors and contacts
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Source ClinicalTrials.gov
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