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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-29
Study Completion:2027-08-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06254950

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
  3. 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. 4. Participants must meet the contraception recommendations.
  1. 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. 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. 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. 4. Participants who have failed 3 or more classes of advanced therapies.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

GastroIntestinal BioSciences
Los Angeles, California, 90067
United States
United Medical Doctors
Murrieta, California, 92563
United States
UCI Health
Orange, California, 92868
United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, 33762
United States
Auzmer Research
Lakeland, Florida, 33813
United States
GI PROS, Inc.
Naples, Florida, 34102
United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
United States
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322
United States
Atlanta Center For Gastroenterology, P.C.
Decatur, Georgia, 30033
United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University Of Louisville
Louisville, Kentucky, 40202
United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061
United States
BVL Clinical Research
Liberty, Missouri, 64068
United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113
United States
Rochester Clinical Research
New York, New York, 14609
United States
DiGiovanna Institute for Medical Education and Research
North Massapequa, New York, 11758-1802
United States
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, 73102
United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29607
United States
Novel Research, LLC
Bellaire, Texas, 77401
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-29
Study Completion Date2027-08-04

Study Record Updates

Study Start Date2024-03-29
Study Completion Date2027-08-04

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy
  • Latitude UC, Latitude Research Program

Additional Relevant MeSH Terms

  • Ulcerative Colitis