Tests TAK-279 in adults with moderately to severely active Crohn's disease
Tests the oral drug TAK-279 against placebo in adults with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Atlanta, Bellaire, Clearwater, Dallas, Decatur, Fort Worth, Glen Burnie, Greenville, Iowa City, Kansas City, Kingwood, Lakeland, Las Vegas, Liberty, Louisville, Mansfield, Mentor, Miami Lakes, Murrieta, Naples, New York, Oklahoma City, Orange, Orlando, Providence, Rochester, San Antonio, Seattle, Tampa, and Tyler, United StatesSee the 30 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06233461, who can take part
Where in United States
- Emory University Hospital, The Emory ClinicAtlanta, United StatesTaking people
- Novel Research LLCBellaire, United StatesTaking people
- West Central Gastroenterology, LLP, d/b/a/ Gastro FloridaClearwater, United StatesTaking people
- TDDC - Baylor University Medical Center Gaston AveDallas, United StatesNo longer taking part
- Atlanta Center For Gastroenterology, P.C.Decatur, United StatesTaking people
- Texas Digestive Disease Consultants, PLLC d/b/a GI AllianceFort Worth, United StatesNo longer taking part
- Woodholme Gastroenterology AssociatesGlen Burnie, United StatesTaking people
- Gastroenterology Associates, PAGreenville, United StatesTaking people
- The University of Iowa Hospitals & ClinicsIowa City, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- One of a Kind Clinical research Center TX LLCKingwood, United StatesTaking people
- Auzmer ResearchLakeland, United StatesTaking people
- Las Vegas Medical ResearchLas Vegas, United StatesTaking people
- BVL Clinical ResearchLiberty, United StatesTaking people
- University of LouisvilleLouisville, United StatesTaking people
- TDDC dba Alliance ResearchMansfield, United StatesNo longer taking part
- Great Lakes Gastroenterology Research, LLCMentor, United StatesTaking people
- Wellness Clinical ResearchMiami Lakes, United StatesTaking people
- United Medical DoctorsMurrieta, United StatesTaking people
- GI PROS, Inc.Naples, United StatesTaking people
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)New York, United StatesTaking people
- Hightower Clinical - SSM HealthOklahoma City, United StatesNo longer taking part
- UCI HealthOrange, United StatesTaking people
- AdventHealth (Florida Hospital) Medical GroupOrlando, United StatesNot yet recruiting
- University Gastroenterology ProvidenceProvidence, United StatesTaking people
- Rochester Clinical Research, IncRochester, United StatesNot yet recruiting
- Southern Star Research Institute, LLCSan Antonio, United StatesTaking people
- University of Washington Medical CenterSeattle, United StatesTaking people
- USF Health Morsani Center for Advanced HealthcareTampa, United StatesTaking people
- Tyler Research Institute, LLCTyler, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Takeda
- Trial code
- NCT06233461EU 2023-506704-14-00
- Record updated
- 2 November 2026
- Original 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.Read full original descriptionShow less
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 (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.
Inclusion: 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; Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI; 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: Have complications of CD that might require surgery during the study; Participants who have failed 3 or more classes of advanced therapies; Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis; Participants with a current ostomy.