A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative ColitisThe main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.
The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).
During the study, participants will visit their study clinic several times.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 to 75
Participation Criteria
Inclusion Criteria:
1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
4. Participants must meet the contraception recommendations.
Exclusion Criteria:
1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.
Study Location
London Health Sciences Centre - University Hospital
London Health Sciences Centre - University HospitalLondon, Ontario
Canada
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Fraser Clinical Trials
Fraser Clinical TrialsNew Westminster, British Columbia
Canada
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Site Contact
6045250155The Research Institute of the McGill University Health Center
The Research Institute of the McGill University Health CenterMontreal, Quebec
Canada
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London Health Sciences Centre - Victoria Hospital
London Health Sciences Centre - Victoria HospitalLondon, Ontario
Canada
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Heritage Medical Research Clinic - University Of Calgary
Heritage Medical Research Clinic - University Of CalgaryCalgary, Alberta
Canada
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Centre Hospitalier de l'Universite de Montreal
Centre Hospitalier de l'Universite de MontrealMontreal, Quebec
Canada
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- Study Sponsored By
- Takeda
- Participants Required
- More Information
- Study ID:
NCT06254950