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
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
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.
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):
This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
Inclusion Criteria:
Exclusion Criteria:
medinfoUS@takeda.com+1-877-825-3327
Murrieta, California 92563, United States
drhongpi@unitedmd.com951-566-5229
Clearwater, Florida 33762, United States
Orlando, Florida 32804, United States
New York, New York 10029, United States
Fort Worth, Texas 76104, United States
Murdoch, Western Australia 6150, Australia
Nedlands, 6009, Australia
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel 1070, Belgium
Liège, 4000, Belgium
Brasília, Federal District 70200-730, Brazil
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Botucatu, São Paulo 18618-970, Brazil
Jaú, São Paulo 17201-130, Brazil
Ribeirão Preto, São Paulo 14048-900, Brazil
Santos, São Paulo 11075-900, Brazil
Sofia, 1527, Bulgaria
Halifax, Nova Scotia B3H 2Y9, Canada
Toronto, Ontario M5G 1X5, Canada
Montreal, Quebec H3G 1A4, Canada
Guangzhou, Guangdong 510080, China
Wuhan, Hubei 430060, China
Shenyang, Liaoning 110022, China
Shanghai, Shanghai Municipality 200127, China
Hangzhou, Zhejiang 310009, China
Guangzhou, 510655, China
Hangzhou, 310016, China
Zhejiang, 310006, China
Ostrava-Poruba, 708 52, Czechia
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Vandœuvre-lès-Nancy, 54511, France
Athens, Attica 11528, Greece
Ramat Gan, 5265601, Israel
Milan, 20132, Italy
Takatsuki-shi, Osaka 569-8686, Japan
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Lorenskog, Akershus 1478, Norway
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Torun, Kujawsko-pomo 87-100, Poland
Szczecin, West Pomeranian Voivodeship 71-434, Poland
Timișoara, Jud Timis 300002, Romania
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London, E1 2at E1 2AT, United Kingdom
Belfast, BT16 1RH, United Kingdom
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