NCT06764615

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 2 years (108 weeks). During the study, participants will visit their study clinic 11 times.

Conditions

• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Zasocitinib	Zasocitinib capsules.

Timeline

• Start date: 2025-05-28
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2025-01-08
• Last updated: 2025-12-29

Locations

16 sites across 8 countries: United States, China, Czechia, Hungary, Netherlands, Poland, Slovakia, South Korea

Regulatory

• FDA-regulated drug study