Using Baricitinib to treat intestinal Behçet's Syndrome

A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients

This study is testing if the medication Baricitinib can help people with tough cases of intestinal Behçet's Syndrome just as well as the current treatment, Adalimumab.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: infliximab, golimumab, certolizumab, tocilizumab, ustekinumab, tofacitinib, baricitinib, Adalimumab
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06849908 on ClinicalTrials.gov

What this trial studies

This study is a randomized controlled trial comparing the efficacy and safety of Baricitinib and Adalimumab in patients with refractory intestinal Behçet's Syndrome. The goal is to determine if Baricitinib is non-inferior to Adalimumab in controlling inflammation, reducing recurrence, alleviating gastrointestinal symptoms, and promoting intestinal mucosal healing. The trial will utilize both intention-to-treat and per-protocol analyses to assess outcomes, with a focus on establishing non-inferiority first and then superiority if applicable.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with intestinal Behçet's Syndrome who have active intestinal ulcers and have not responded adequately to previous treatments.

Not a fit: Patients who have not been diagnosed with intestinal Behçet's Syndrome or those who have not experienced treatment failure with existing therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from refractory intestinal Behçet's Syndrome.

How similar studies have performed: Other studies have shown promising results with similar biologic treatments for Behçet's Syndrome, but the specific use of Baricitinib in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jinjing Liu, M.D.

Conditions Behcet Syndrome, Intestinal Type; Baricitinib; Adalimumab; Intestinal Behçet's Syndrome