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

NCT06254950 · tracked via the Priya Life Science UK tracker

Sponsor

Takeda

Phase

Phase 2

Started

2024-03-29

Last updated

2026-08-17

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

TAK-279Placebo

TAK-279: TAK-279 capsules.

Placebo: TAK-279 placebo-matching capsules.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) — Week 12
The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).

Trial sites (141)

Facility	City	Region
GastroIntestinal BioSciences	Los Angeles	California
United Medical Doctors	Murrieta	California
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida	Clearwater	Florida
Auzmer Research	Lakeland	Florida
GI PROS, Inc.	Naples	Florida
USF Health Morsani Center for Advanced Healthcare	Tampa	Florida
Emory University Hospital, The Emory Clinic	Atlanta	Georgia
Atlanta Center For Gastroenterology, P.C.	Decatur	Georgia
University Of Louisville	Louisville	Kentucky
Woodholme Gastroenterology Associates	Glen Burnie	Maryland
Las Vegas Medical Research	Las Vegas	Nevada
University Gastroenterology	Providence	Rhode Island
Gastroenterology Associates, PA	Greenville	South Carolina
Novel Research, LLC	Bellaire	Texas
Tyler Research Institute, LLC	Tyler	Texas
University of Washington Medical Center	Seattle	Washington
Concord Repatriation General Hospital	Sydney	New South Wales
Mater Cancer Care Centre-Mater Health Services	South Brisbane	Queensland
Flinders Medical Centre	Bedford Park	South Australia
The Queen Elizabeth Hospital	Woodville	South Australia
The Alfred Hospital	Melbourne	Victoria
Western Health/Footscray Hospital	Melbourne	Victoria
Sir Charles Gairdner Hospital Lung Institute Of Western Australia	Nedlands	Western Australia
Royal Perth Hospital	Perth	Western Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital	Murdoch	Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel	Brussels	Anderlecht / Region Capitale de Bruxelles/ Brussel
Universitair Ziekenhuis Leuven	Leuven	Belgium
UMBAL Kaspela	Plovdiv	Bulgaria
Pecs University Clinical Center Mohacs Hospital	Sofia	Bulgaria
Acibadem City clinic Tokuda hospital	Sofia	Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD	Sofia	Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)	Sofia	Bulgaria
University Hospital City Clinic Cancer Center	Sofia	Bulgaria
Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta
Fraser Clinical Trials	New Westminster	British Columbia
London Health Sciences Centre - University Hospital	London	Ontario
London Health Sciences Centre - Victoria Hospital	London	Ontario
Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
The Research Institute of the McGill University Health Center	Montreal	Quebec
Chongqing General Hospital	Chongqing	Chongqing Sheng

+ 101 more sites — see the full list on the official registry below.

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Other trials for the same condition

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC) Active, not recruiting

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population Active, not recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06254950 on ClinicalTrials.gov ↗ ← All trials in the UK