Phase 2b study Oral TAK-279 in Subjects with Moderately to Severely active Crohns Disease
Research type
Research Study
Full title
A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease
IRAS ID
1009626
Contact name
Nimita Singh
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2023-506704-14
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 & decrease the chances of it coming back. TAK-279 is a potential treatment for CD taken as capsules by mouth. In this study, participants with CD who are having flareups (moderately to severely active CD) will be included in the study. They will either take 1 of 3 doses of TAK-279 or a placebo once a day for up to 52 weeks (1 year), there will also be a screening & follow up period to the study meaning the total time a participant can be in the study is 60 weeks (around 1 year and 2 months).
The main aims of the study are to learn if the 3 different doses of TAK-279 reduce inflammation & ulcers in the bowel compared to the placebo after 12 weeks of treatment & to compare any medical problems that participants have when taking TAK-279 or placebo & how well the participants tolerate any problems.
This is a double-blind study. This means that neither the participants nor the study doctors will know which 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 1 of 4 study treatments by chance. The 4 study treatments are TAK-279 at 3 doses (low, middle, &high doses) & placebo. Participants will take 3 capsules once a day for up to 52 weeks (1 year). After 12 weeks of treatment, if participants taking the placebo have their disease getting worse, they will be switched to the middle dose of TAK-279. Participants taking TAK279 will continue taking their assigned dose for the rest of their treatment in the study. There will be a safety follow-up visit 4 weeks after their last day of treatment.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0134
Date of REC Opinion
24 Jul 2024
REC opinion
Further Information Favourable Opinion