Trial Evaluate Safety, Tolerability, PK, of Zasocitinib in Participants with Active Crohn’s Disease
Research type
Research Study
Full title
An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn’s Disease
IRAS ID
1013471
Contact name
Jonathan Sherlock
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc
Clinicaltrials.gov Identifier
Research summary
Crohn’s disease (CD) is a serious, long-term condition that can cause swelling (inflammation) & painful ulcers anywhere in the gut but most commonly in the bowel. Common symptoms include diarrhoea, bleeding, & abdominal pain. There is no known cure, but some treatments can reduce inflammation. Zasocitinib (TAK-279) is a potential treatment for CD taken as capsules by mouth. In this study, participants with CD who are having flareups (active CD) will be included in the study.
The main aims of the study are to evaluate the safety and tolerability of TAK-279 and understand how it affects the disease after 12 weeks of treatment.
This is an Open-Label study. This means that the participants and the study doctors will know the treatment each participant is taking.
Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 30 days. If participants meet the study rules, they will be assigned to the study treatment.
They will take 3 capsules of (TAK-279) once a day for up to 12 weeks, there will also be a screening & follow up period to the study meaning the total time a participant can be in the study is 20 weeks (around 4.6 months). After this period, participants who adequately respond to Zasocitinib (TAK-279) may be offered the opportunity to continue treatment in a separate long-term extension study. For those participants not continuing in the long-term extension study, there will be a safety follow-up visit on week 16, which is 4 weeks after the last day of treatment.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
26/NW/0037
Date of REC Opinion
19 Mar 2026
REC opinion
Further Information Favourable Opinion