NCT06780683

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 174 (estimated)
• Sponsor: Xiang Gao · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.

Conditions

• Inflammatory Bowel Disease
• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Upadacitinib	Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease). Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.

Timeline

• Start date: 2024-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

6 sites across 1 country: China