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

NCT07833163 | Not Yet Recruiting Phase 2

• 1 other identifier: PKU People's Hospital2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behçet's Syndrome; Behçet's Syndrome (BS)

Keywords

Behçet's syndrome; Corticotropin; mucosal lesions; immune-inflammatory mechanism

Outcome Measures

Primary Outcomes (2)

• 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

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

  Baseline, Week 12

Secondary Outcomes (5)

• Change in disease activity score

  From baseline up to Week 24

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

  Baseline (Week 0), Week 12

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

  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

  Baseline (Week 0), Week 12

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

  Baseline (Week 0), Week 12

Other Outcomes (1)

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

  Randomization until Week 24

Study Arms (2)

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.

Drug: Repository Corticotropin Injection (ACTH)

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.

Drug: Study-matched inactive placebo injection, also called control injection

Interventions

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.

ACTH Treatment Group

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.

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

• Criteria for diagnosis of Behcet's disease. International Study Group for Behcet's Disease. Lancet. 1990 May 5;335(8697):1078-80.

  PMID: 1970380 RESULT

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Tian T Liu Tian T Liu

CONTACT

• +86 136 6134 5637; liutian03973@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)