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RECRUITING
NCT06849908
PHASE2

Baricitinib in the Treatment of Intestinal Behçet's Syndrome

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-11-08

Completion Date

2028-06-30

Last Updated

2025-02-27

Healthy Volunteers

No

Interventions

DRUG

Baricitinib

Participants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months.

DRUG

Adalimumab

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.

Locations (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, China