drugset / Trial / NCT06849908

Baricitinib in the Treatment of Intestinal Behçet's Syndrome

NCT06849908

Phase 2 Recruiting 56 enrolled Peking Union Medical College Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-11-08
Primary completion
2027-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Baricitinib Small molecule 4 mg

Indications