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Taking people in CzechiaPhase 2

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.

Key facts

Who runs it
Takeda
Where
Brno, Brno-Sever, Brno-Zidenice, České Budějovice, Hradec Králové, Olomouc, Ostrava, Pardubice, Prague, Prague 5, Slezska Ostrava, and Ústí nad Labem, CzechiaSee the 13 sitesAlso in 24 other countries, 193 sites
Trial code
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
Status
Recruiting
Phase
Phase 2
People taking part
268 people, planned
Started
5 Mar 2024
Expected to end
23 Jul 2027
Type of study
Interventional, 4 groups
Treatments tested
  • TAK-279
  • Placebo
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active Crohn's disease who have already tried at least one other treatment without enough benefit or could not tolerate it.

Age
18 to 75 years (19 or older in South Korea)
Sex
All sexes can join
Disease stage
Moderately to severely active Crohn's disease, diagnosed at least 30 days ago, confirmed with the SES-CD and CDAI scores
Earlier treatment
Must have had an inadequate response, lost response, or could not tolerate at least one conventional, biologic, or advanced therapy for Crohn's disease. People who failed 3 or more classes of advanced therapies cannot join.

Main reasons for not taking part

  • Other types of colitis (indeterminate, microscopic, ischemic, infectious, radiation, diverticular-related) or ulcerative colitis
  • Crohn's complications that might need surgery during the study
  • A current ostomy
  • Failed 3 or more classes of advanced therapies

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Czechia

Also in 24 other countries, 193 sites

  • Fakultni nemocnice BrnoBrno, CzechiaTaking people
  • SurGal Clinic s.r.o.Brno-Sever, CzechiaTaking people
  • Vojenska Nemocnice BrnoBrno-Zidenice, CzechiaTaking people
  • Nemocnice České Budějovice, a.s.České Budějovice, CzechiaTaking people
  • Hepato-Gastroenterologie HK, s.r.o.Hradec Králové, CzechiaTaking people
  • PreventaMed, s.r.o.Olomouc, CzechiaTaking people
  • Fakultni nemocnice OstravaOstrava, CzechiaTaking people
  • Gastromedic s.r.oPardubice, CzechiaTaking people
  • Endohope klinika s.r.o.Prague, CzechiaTaking people
  • Fakultni nemocnice Kralovske VinohradyPrague, CzechiaTaking people
  • Axon Clinical s.r.o.Prague 5, CzechiaTaking people
  • EndoArt s.r.o.Slezska Ostrava, CzechiaTaking people
  • Krajská zdravotní a.s. - Masarykova nemocnice Ústí nad Labem, o.z.Ústí nad Labem, CzechiaTaking people

About the trial

What the trial wants to find out

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

The participants will be treated with TAK-279 for 52 weeks (1 year).

During the study, participants will visit their study clinic 15 times.

The 4 groups in the trial

  • TAK-279 Dose 1Treatment being tested

    Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.

    Treatment: TAK-279 and Placebo

  • TAK-279 Dose 2Treatment being tested

    Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.

    Treatment: TAK-279 and Placebo

  • TAK-279 Dose 3Treatment being tested

    Participants will be randomized to receive TAK-279 Dose 3 capsules orally.

    Treatment: TAK-279

  • PlaceboTreatment being tested

    Participants will be randomized to receive TAK-279 placebo-matching capsules orally.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests TAK-279 in adults with moderately to severely active Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06233461, who can take part
Record updated
2 November 2026