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 Crohn's Disease

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

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.

Official Title

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

Quick Facts

Study Start:2024-03-05
Study Completion:2027-07-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233461

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 CD 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 CD assessed by SES-CD and CDAI.
  3. 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. 1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
  2. 2. Have complications of CD that might require surgery during the study.
  3. 3. Participants with a current ostomy.
  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
Wellness Clinical Research
Miami Lakes, Florida, 33016
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
The University of Iowa Hospitals & 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, 89128
United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029
United States
DiGiovanna Institute for Medical Education and Research
North Massapequa, New York, 11758-1802
United States
Rochester Clinical Research
Rochester, New York, 14609
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
United States
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, 73102
United States
University Gastroenterology
Providence, Rhode Island, 02904
United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615
United States
Novel Research, LLC
Bellaire, Texas, 77401
United States
TDDC - Baylor University Medical Center Gaston Ave
Dallas, Texas, 75246
United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Fort Worth, Texas, 76104
United States
TDDC dba Alliance Research
Mansfield, Texas, 76063
United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
United States
Tyler Research Institute, LLC
Tyler, Texas, 75701
United States
Tidewater Gastroenterology, P.L.L.C. d/b/a Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
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 Date2024-03-05
Study Completion Date2027-07-23

Study Record Updates

Study Start Date2024-03-05
Study Completion Date2027-07-23

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy
  • Latitude CD, Latitude Research Program

Additional Relevant MeSH Terms

  • Crohn's Disease