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

Description

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.

Conditions

Crohn's Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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 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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

GastroIntestinal BioSciences, Los Angeles, California, United States, 90067

Murrieta

United Medical Doctors, Murrieta, California, United States, 92563

Orange

UCI Health, Orange, California, United States, 92868

Clearwater

West Central Gastroenterology, LLP, d/b/a/ Gastro Florida, Clearwater, Florida, United States, 33762

Lakeland

Auzmer Research, Lakeland, Florida, United States, 33813

Miami Lakes

Wellness Clinical Research, Miami Lakes, Florida, United States, 33016

Naples

GI PROS, Inc., Naples, Florida, United States, 34102

Tampa

USF Health Morsani Center for Advanced Healthcare, Tampa, Florida, United States, 33612

Atlanta

Emory University Hospital, The Emory Clinic, Atlanta, Georgia, United States, 30322

Decatur

Atlanta Center For Gastroenterology, P.C., Decatur, Georgia, United States, 30033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2027-07-23