Phase 2: testing Baricitinib for Behcet Syndrome, Intestinal Type
This study aims to conduct a randomly assigned controlled trial to compare the how well it works and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS). The objective is to demonstrate if Baricitinib is non-inferior to ADA in controlling BS inflammation, reducing BS recurrence， alleviating gastrointestinal symptoms and promoting intestinal mucosal healing.
Official registry: https://clinicaltrials.gov/study/NCT06849908 · Peking Union Medical College Hospital · enrollment listed as 56
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Baricitinib, or Adalimumab. The registry lists allocation as randomized. This study aims to conduct a randomly assigned controlled trial to compare the how well it works and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS).
They plan to enroll about 56 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients
Interventions: Baricitinib, Adalimumab
Primary outcome (registry wording): Proportion of patients with marked improvement (MI) at week 24 of follow-up
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;
- Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;
- Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks;
Who the registry excludes
- Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;
- 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;
- 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;
- 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;
- Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion;
- Primary immunodeficiency disease;
- History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies;
Public study contact (from the registry)
Jinjing Liu, M.D.
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (not_yet_recruiting)
- Peking Union Medical College Hospital — Beijing, China (recruiting)
FAQ about this NCT record
Is NCT06849908 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06849908?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06849908?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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