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

What Was Tested

In this phase 2 trial, researchers set out to test ACTH (Corticotropin).

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.

It had two arms (groups): ACTH Treatment Group (experimental) and 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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

As a double-blind ACTH (Corticotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-09 with completion listed for 2027-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the number of active oral aphthous ulcers from baseline to Week 12 (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).

It also tracked 5 secondary outcomes, for example Change in disease activity score, Change in number of active genital ulcers from baseline to Week 12, Change in visual analog scale (VAS) pain score of oral ulcers from baseline to Week 12, Change in Behçet's Disease Current Activity Form (BDCAF) and Behçet Syndrome Activity Score (BSAS) from baseline to Week 12 and Change in 36-Item Short Form Health Survey (SF-36) total score from baseline to Week 12.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.