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
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
- Crohn's Disease
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Takeda
- Enrolment target
- 268
- Started
- 5 March 2024
- Main results due
- 17 February 2027
- Study sites
- 201
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 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. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI. 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. Exclusion Criteria: 1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis. 2. Have complications of CD that might require surgery during the study. 3. Participants with a current ostomy. 4. Participants who have failed 3 or more classes of advanced therapies.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(201)
United Medical Doctors
Murrieta, California, United States
Recruiting
UCI Health
Orange, California, United States
Recruiting
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, United States
Recruiting
Auzmer Research
Lakeland, Florida, United States
Recruiting
Wellness Clinical Research
Miami Lakes, Florida, United States
Recruiting
GI PROS, Inc.
Naples, Florida, United States
Recruiting
AdventHealth (Florida Hospital) Medical Group
Orlando, Florida, United States
Not yet recruiting
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Recruiting
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, United States
Recruiting
Atlanta Center For Gastroenterology, P.C.
Decatur, Georgia, United States
Recruiting
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
University Of Louisville
Louisville, Kentucky, United States
Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Recruiting
BVL Clinical Research
Liberty, Missouri, United States
Recruiting
Las Vegas Medical Research
Las Vegas, Nevada, United States
Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, United States
Recruiting
Rochester Clinical Research, Inc
Rochester, New York, United States
Not yet recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Recruiting
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, United States
Completed
University Gastroenterology Providence
Providence, Rhode Island, United States
Recruiting
Gastroenterology Associates, PA
Greenville, South Carolina, United States
Recruiting
Novel Research, LLC
Bellaire, Texas, United States
Recruiting
TDDC - Baylor University Medical Center Gaston Ave
Dallas, Texas, United States
Completed
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Fort Worth, Texas, United States
Completed
One of a Kind Clinical research Center TX LLC
Kingwood, Texas, United States
Recruiting
TDDC dba Alliance Research
Mansfield, Texas, United States
Completed
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Recruiting
Tyler Research Institute, LLC
Tyler, Texas, United States
Recruiting
University of Washington Medical Center
Seattle, Washington, United States
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Mater Cancer Care Centre-Mater Health Services
South Brisbane, Queensland, Australia
Recruiting
Flinders Medical Centre
Bedford Park, South Australia, Australia
Recruiting
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Recruiting
Western Health/Footscray Hospital
Footscray, Victoria, Australia
Recruiting
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Recruiting
Royal Perth Hospital
Perth, Western Australia, Australia
Recruiting
Northern Hospital Epping
Epping, Australia
Recruiting
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
Nedlands, Australia
Recruiting
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium
Recruiting
CHU Saint-Pierre - Porte de Hal
Brussels, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, Belgium
Recruiting
L2 IP - Instituto de Pesquisas Clinicas LTDA
Brasília, Federal District, Brazil
Recruiting
Galileo Medical Research
Juiz de Fora, Minas Gerais, Brazil
Recruiting
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Not yet recruiting
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Not yet recruiting
UniversidadeEstadualde Campinas - UNICAMP
Campinas, São Paulo, Brazil
Recruiting
Centro de Estudos Clnicos do Interior Paulista (CECIP)
Jaú, São Paulo, Brazil
Not yet recruiting
Ribeiralo Preto Medical School, University of Salo Paulo
Ribeirão Preto, São Paulo, Brazil
Recruiting
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, Brazil
Recruiting
Solare Trials
São Paulo, Brazil
Recruiting
UMHAT Kaspela
Plovdiv, Bulgaria
Recruiting
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
Sliven, Bulgaria
Recruiting
Acibadem City clinic Tokuda hospital
Sofia, Bulgaria
Recruiting
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, Bulgaria
Recruiting
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
Sofia, Bulgaria
Recruiting
Acibadem City Clinic Mladost Hospital
Sofia, Bulgaria
Recruiting
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
Recruiting
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Recruiting
Showing 60 of 201 sites — filter to narrow it down. 189 of the 201 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06233461. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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