Can an oral drug match a standard injection for Hard-to-Treat intestinal Behçet's?
NCT ID NCT06849908
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers compare two drugs, baricitinib and adalimumab, in people with intestinal Behçet's syndrome that has not improved with standard treatments. Participants receive one of the drugs for six months while continuing their existing steroids or immune-modulating medicines. The trial measures changes in gut symptoms and colonoscopy findings to see whether baricitinib is at least as effective as adalimumab at controlling inflammation and helping ulcers heal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- baricitinib, an oral drug that dampens the immune system
- What this could lead to
- If baricitinib works as well as adalimumab, it could offer an oral alternative for people whose intestinal Behçet's syndrome has not responded to other treatments.
- What could go wrong
- This is a small Phase 2 trial with 56 participants, so results may not hold in larger groups. Baricitinib suppresses the immune system, which can raise the risk of infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Refer to the consensus on the diagnosis and treatment of intestinal Behçet's syndrome in China: Patients who meet the 2013 International Criteria for Behçet's Disease (ICBD) and have typical Behçet's syndrome-related intestinal ulcers confirmed by colonoscopy, or patients diagnosed according to the criteria for Behçet's syndrome established by the Korean Behçet's Disease Collaborative Group in 2009; 2. Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline; 3. Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers; 4. Patients who have been treated with medium to high-dose steroids (prednisolone equivalent of 0.5-1 mg/kg/day) for more than 1 month continuously, or any immunomodulator/Immunosuppressants for more than 3 months regularly or biologics for more than 2 months, as judged by the doctor to be treatment failure or intolerance; 5. Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks; 6. Understanding the research process, voluntary participation, and signing of informed consent. Exclusion Criteria: 1. Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.; 2. Other active organ damage related to BS requires intensified immunosuppressive therapy, including aneurysms, uveitis, and substantial involvement of the central nervous system; skin lesions and joint involvement can be included; 3. Severe organ dysfunction including ALT, AST, TBIL levels exceeding twice the upper limit of normal, creatinine levels exceeding 1.5 times the upper limit of normal, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelets \< 100×10\^9/L; 4. Active infections such as active tuberculosis, active hepatitis B or C, syphilis, chronic Epstein-Barr virus infection, HIV infection, sustained or severe bacterial or viral infections, and history of severe herpes zoster; 5. Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion; 6. Primary immunodeficiency disease; 7. History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies; 8. Patients who did not respond to infliximab treatment for primary refractory BS (patients with secondary failure, intolerance, or allergy to infliximab should be included); 9. Patients treated with biologics/small molecule targeting therapies within 5 half-lives (including use of tofacitinib within 10 days, etanercept within 4 weeks, infliximab within 8 weeks, golimumab, certolizumab, abatacept, and tocilizumab within 10 weeks, ustekinumab within 6 months); 10. Patients with prior use of baricitinib or ADA; 11. Complications of intestinal BS such as symptomatic stenosis, short bowel syndrome, intestinal fistula, or suspected intra-abdominal abscess; potential need for surgery or situations not conducive to DAIBD and efficacy assessment; any form of intestinal resection or other abdominal surgery within 6 months before baseline; presence of a functioning (i.e., patent) stoma or ostomy; 12. Patients requiring parenteral nutrition due to disease severity; 13. Pregnant, lactating, or planning pregnancy soon; 14. Patients unwilling or unable to comply with regular visits; 15. History of severe thrombotic events or chronic cardiovascular events.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking Union Medical College Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100730, China
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Peking Union Medical College Hospital
RECRUITINGBeijing, China