RECRUITING

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

Description

The 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.

Conditions

Ulcerative Colitis
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Related Conditions:

Ulcerative Colitis

Study Overview

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Study Details

Study overview

The 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.

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

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

Condition
Ulcerative Colitis
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

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

Iowa City

Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

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 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.
  • 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.

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

2027-08-04