Behçet's SyndromePhase 2NCT07833163
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
A Phase 2 study testing Repository Corticotropin Injection (ACTH) in people with Behçet's Syndrome and Behçet's Syndrome (BS), run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behçet's Syndrome, Behçet's Syndrome (BS)
- What is being tested?
- Repository Corticotropin Injection (ACTH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100032
Tian Liu, +86 136 6134 5637, liutian03973@pku.edu.cn
Xiaoxin Gong, +86 151 2814 5159
About this study
Official title: A Multicenter Randomized Controlled Trial of Corticotropin for the Treatment of Behçet's Disease
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)
- Being tested
- Repository Corticotropin Injection (ACTH), Study-matched inactive placebo injection, also called control injection
- Keywords
- Behçet's syndrome, Corticotropin, mucosal lesions, immune-inflammatory mechanism
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Study-matched inactive placebo injection, also called control injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Study-matched inactive placebo injection, also called control injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Week 12
Change in Behçet's disease mucosal lesion score from baseline at week 12
Measured: Baseline, Week 12
Secondary outcomes (5)
Change in disease activity score
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behçet's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Tian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833163
- Sponsor's protocol ID
- PKU People's Hospital2026
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers to protect participant privacy and comply with institutional data management regulations. Only aggregated summary results will be published.
Publications
Criteria for diagnosis of Behcet's disease. International Study Group for Behcet's Disease. Lancet. 1990 May 5;335(8697):1078-80.
PubMed 1970380
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Corticotropin for the Treatment of Behçet's Disease
- ClinicalTrials.gov ID
- NCT07833163
- Acronym / sponsor ID
- PKU People's Hospital2026
- Conditions
- Behçet's Syndrome, Behçet's Syndrome (BS)
- Keywords
- Behçet's syndrome, Corticotropin, mucosal lesions, immune-inflammatory mechanism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| ACTH Treatment Group | Experimental | Drug: Repository Corticotropin Injection (ACTH)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. |
| Placebo Control Group | Placebo comparator | Drug: Study-matched inactive placebo injection, also called control injectionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repository Corticotropin Injection (ACTH)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. | Drug | ACTH Treatment Group |
| Study-matched inactive placebo injection, also called control injectionParticipants 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. | Drug | Placebo Control Group |
Primary outcome
Change in the number of active oral aphthous ulcers from baseline to Week 12
Time frame: Baseline (Week 0) and 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.
Change in Behçet's disease mucosal lesion score from baseline at week 12
Time frame: Baseline, Week 12
5 secondary outcomes
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
Time frame: Baseline (Week 0), Week 12
Change in visual analog scale (VAS) pain score of oral ulcers from baseline to Week 12
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
Time frame: Baseline (Week 0), Week 12
Change in 36-Item Short Form Health Survey (SF-36) total score from baseline to Week 12
Time frame: Baseline (Week 0), Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 1970380Criteria for diagnosis of Behcet's disease. International Study Group for Behcet's Disease. Lancet. 1990 May 5;335(8697):1078-80.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers to protect participant privacy and comply with institutional data management regulations. Only aggregated summary results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Repository Corticotropin Injection (ACTH) in people with Behçet's Syndrome and Behçet's Syndrome (BS), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian T Liu Tian T Liu (• +86 136 6134 5637 ext. Xiaoxin X Gong, liutian03973@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of active oral aphthous ulcers from baseline to Week 12 (time frame: Baseline (Week 0) and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07833163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.