At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TAK-279 (drug), Placebo (drug)
- How long the study runs
- Study runs about 40 months (dates as stated)
- About the drug or intervention
- TAK-279 — drug: TAK-279 capsules. · Placebo — drug: TAK-279 placebo-matching capsules.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 268
- Started
- 2024-03-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Phase2 - 268 participants
- • Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with crohn's disease
Where?
- • Cambridge - Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
- • London - Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
- • Belfast - South Eastern Health and Social Care Trust - The Ulster Hospital
- • London - St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.
More detail
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement...
- ✓Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
- ✓Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more...
Who cannot take part
- ✗Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation...
- ✗Have complications of CD that might require surgery during the study.
- ✗Participants with a current ostomy.
- ✗Participants who have failed 3 or more classes of advanced therapies.
See the full criteria
Where Is This Study? (5 UK sites)
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
London E1 2AT, United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast BT16 1RH, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London SE1 7EH, United Kingdom
NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust
London W1T 7HA, United Kingdom
How to Get in Touch
Takeda Contact
Sponsor contactCONTACT