Last updated 10 days ago

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

268 patients around the world
Available in Brazil, United States
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.
Takeda
7Research sites
268Patients around the world

This study is for people with

Crohn's disease

Requirements for the patient

To 75 Years
All Gender

Medical requirements

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.
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.

Sites

L2IP Instituto de Pesquisas Clínicas - Brasilia
SGAS 613, Conj. E Bloco A , Sala 06 - Subsolo , Asa Sul - Brasília/DF, CEP: 70.200-730
Hospital de Clínicas de Porto Alegre
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
s/n, Av. Prof. Montenegro - Distrito de, Botucatu - SP, 18618-687
Hospital de Clínicas - Universidade Estadual de Campinas - UNICAMP
R. Vital Brasil, 251 - Cidade Universitária, Campinas - SP, 13083-888
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
R. Bento Manoel, 290 - Centro, Jaú - SP, 17201-130
Hospital das Clínicas de Ribeirão Preto
Campus Universitário S/N, Bloco G Subsolo II, Monte Alegre, Ribeirão Preto, Sao Paulo
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-101
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