ClinicalTrials.gov record NCT07833163

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old to 65 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 2 randomized, quadruple-masked trial compares repository corticotropin (ACTH) injections with matching placebo in people with Behçet's syndrome who have active mucosal lesions. Participants receive intramuscular injections twice weekly for 12 weeks, then are observed for 12 more weeks without treatment. The study measures ulcer counts, pain, disease activity, and quality of life through Week 24.

What it is studying. Whether repository corticotropin (ACTH) injections change the number or severity of oral and genital ulcers, pain levels, and overall disease activity compared with placebo.

What the researchers hope to learn. To evaluate the efficacy and safety of repository corticotropin (ACTH) for treating mucosal (oral and genital) lesions in Behçet's syndrome and to provide evidence to inform clinical use.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Repository Corticotropin Injection (ACTH)
  • Study-matched inactive placebo injection, also called control injection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would have a screening visit to confirm a Behçet's diagnosis and that you have at least two active oral ulcers. If enrolled, you would be randomly assigned to receive intramuscular injections twice weekly for 12 weeks of either repository corticotropin (ACTH) or a matching inactive placebo, then complete a 12‑week off-treatment follow-up; systemic glucocorticoids, immunosuppressants and other drugs that could affect the study assessments are not allowed during the treatment period. At scheduled visits you will have counts and scoring of oral and genital ulcers, mucosal lesion assessments, pain ratings using a visual analog scale, disease activity questionnaires (BDCAF and BSAS), and a quality-of-life survey (SF-36); some outcomes are followed up through Week 24.

How the study is structured. Adults are randomly assigned to one of two groups in a parallel design: ACTH (repository corticotropin) intramuscular injections 25 IU twice weekly for 12 weeks, or a matching placebo injection on the same schedule. The study is quadruple-masked (participants, caregivers, investigators, and outcome assessors are masked). Systemic glucocorticoids, immunosuppressants, and other drugs that might interfere with assessing efficacy are not allowed during the 12-week treatment period. After the intervention, all participants enter a 12-week off-treatment follow-up for continued efficacy and safety observations; key measurements are taken at baseline, Week 12, and up to Week 24.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Behçet's disease

This trial is also listed on this site under familial Mediterranean fever.

Clinical trials34 trials listed for Behçet's diseaseEvery trial the registry lists for Behçet's disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Behçet's disease researchLatest monthly update: September 2026. Includes: Low-dose IL-2 trial. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
September 2026 (estimated)
Primary completion
September 2027 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Sep 22, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Peking University People's Hospital
Principal investigator
Liu Tian, Associate Professor
Peking University People's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

glucocorticoids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Study Group
One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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