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Evaluating TAK-279 for reducing bowel inflammation in 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

Phase 2 Interventional Takeda · NCT06233461

This study is testing if a new medication called TAK-279 can help reduce bowel inflammation in people with moderate to severe Crohn's disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment268 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsradiation
Locations193 sites (Los Angeles, California and 192 other locations)
Trial IDNCT06233461 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of TAK-279 in participants with moderately to severely active Crohn's disease. Participants will be randomly assigned to receive one of three doses of TAK-279 or a placebo over a 52-week period, with their bowel inflammation monitored through endoscopy. The study will involve approximately 268 participants and will include 15 clinic visits to evaluate treatment effects and tolerability. The primary goal is to determine if TAK-279 can effectively reduce bowel inflammation and ulcers compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of moderately to severely active Crohn's disease who have not responded adequately to previous therapies.

Not a fit: Patients with indeterminate colitis, those requiring surgery for complications of Crohn's disease, or those who have failed multiple advanced therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of Crohn's disease and enhance patients' quality of life.

How similar studies have performed: Other studies have shown promise with similar approaches in treating Crohn's disease, but the specific efficacy of TAK-279 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 192 other locations

+143 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseDrug TherapyLatitude CD, Latitude Research Program
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.