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
Crohn's DiseaseCrohn'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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 to 75
Critères de participation
Inclusion Criteria:
1. 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.
2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
3. 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 Criteria:
1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
2. Have complications of CD that might require surgery during the study.
3. Participants with a current ostomy.
4. Participants who have failed 3 or more classes of advanced therapies.
Lieu de l'étude
(G.I.R.I) GI Research Institute Foundation
(G.I.R.I) GI Research Institute FoundationVancouver, British Columbia
Canada
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Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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Fraser Clinical Trials
Fraser Clinical TrialsNew Westminster, British Columbia
Canada
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Site Contact
London Health Sciences Centre - Victoria Hospital
London Health Sciences Centre - Victoria HospitalLondon, Ontario
Canada
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Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences CentreHalifax, Nova Scotia
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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Heritage Medical Research Clinic - University Of Calgary
Heritage Medical Research Clinic - University Of CalgaryCalgary, Alberta
Canada
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London Health Sciences Centre - University Hospital
London Health Sciences Centre - University HospitalLondon, Ontario
Canada
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The Research Institute of the McGill University Health Center
The Research Institute of the McGill University Health CenterMontreal, Quebec
Canada
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- Étude parrainée par
- Takeda
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06233461