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
- Esbjerg, Gistrup, Hilleroed, Hvidovre, Koege, and Odense C, DenmarkSee the 6 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 Denmark
- Esbjerg Og Grindsted SygehusEsbjerg, DenmarkTaking people
- Region NordjyllandGistrup, DenmarkTaking people
- Hillerod HospitalHilleroed, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Region SjaellandKoege, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking 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.