Status:
RECRUITING
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Takeda
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \>=19 years of age.
- 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 conventional, biologic, or advanced therapy for CD.
Exclusion
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- 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.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 23 2027
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT06233461
Start Date
March 5 2024
End Date
July 23 2027
Last Update
February 11 2026
Active Locations (176)
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1
GastroIntestinal BioSciences
Los Angeles, California, United States, 90067
2
United Medical Doctors
Murrieta, California, United States, 92563
3
UCI Health
Orange, California, United States, 92868
4
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, United States, 33762