Open-Label Extension Trial of Long-term Safety of Oral TAK-279 in Participants with UC and CD
Research type
Research Study
Full title
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
IRAS ID
1011817
Contact name
Namita Singh
Contact email
Sponsor organisation
Takeda Development Center Americas Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
This is an open label extension study for an investigational treatment for moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC). Participants who took part in one of the two parent studies will be invited to partake in this follow up study, to evaluate the long-term safety and tolerability of oral Zasocitinib (TAK-279).
Participants will receive Zasocitinib (TAK-279) open-label for up to 108 weeks. This is given orally (tablets to swallow). Then there will be a 4-week safety follow up.
This study is being done to help answer the following question(s):
• How does your Crohn’s disease (CD) or ulcerative colitis (UC) respond to the Zasocitinib (TAK-279) during the long-term treatment?
• How safe is Zasocitinib (TAK-279) and what are the side effects that might be related to it?This study will have approximately 183 people participate between the ages of 18 to 75 at the time of the enrollment into the parent trials. The study will take place at about 150 hospitals in 20 countries in North America, Europe, and Asia.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0376
Date of REC Opinion
27 Jun 2025
REC opinion
Further Information Favourable Opinion