Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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. Exclusion Criteria: 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.

Treatments Being Tested

DRUG

TAK-279

TAK-279 capsules.

DRUG

Placebo

TAK-279 placebo-matching capsules.

Locations (20)

GastroIntestinal BioSciences
Los Angeles, California, United States
United Medical Doctors
Murrieta, California, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, United States
Auzmer Research
Lakeland, Florida, United States
GI PROS, Inc.
Naples, Florida, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, United States
Atlanta Center For Gastroenterology, P.C.
Decatur, Georgia, United States
University Of Louisville
Louisville, Kentucky, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastroenterology Associates, PA
Greenville, South Carolina, United States
Novel Research, LLC
Bellaire, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Concord Repatriation General Hospital
Sydney, New South Wales, Australia
Mater Cancer Care Centre-Mater Health Services
South Brisbane, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia