Baricitinib in the Treatment of Intestinal Behçet's Syndrome

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06849908
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Behcet Syndrome, Intestinal Type

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months.
  • Adalimumab — DRUG
    Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with ADA (initially ADA 160 mg subcutaneous injection, followed by 80 mg ADA after 2 weeks, then 40 mg ADA every 2 weeks thereafter) for 6 months.

Study Details

This study aims to conduct a randomized controlled trial to compare the efficacy 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.

Key Dates

Start date
Nov 8, 2024
Status verified
Feb 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib for IBS
  • Experimental: Adalimumab for IBS

Primary Outcome Measure

Proportion of patients with marked improvement (MI) at week 24 of follow-up [ Time Frame: Baseline to week 24 ]

Central Contacts