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Evaluating TAK-279 for reducing bowel inflammation in ulcerative colitis

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis

Phase 2 Interventional Takeda · NCT06254950

This study is testing if a new medication called TAK-279 can help reduce inflammation and symptoms in people with moderate to severe ulcerative colitis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment207 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsradiation
Locations176 sites (Los Angeles, California and 175 other locations)
Trial IDNCT06254950 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of TAK-279 in reducing inflammation and symptoms in participants with moderately to severely active ulcerative colitis. It is a multicenter, randomized, placebo-controlled trial with a 12-week double-blinded induction phase followed by a 40-week open-label treatment phase. Approximately 207 participants will be randomized into three groups: two doses of TAK-279 and a placebo. Participants will take the assigned treatment for up to 52 weeks, with regular clinic visits to monitor their health and any side effects.

Who should consider this trial

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

Not a fit: Patients with indeterminate inflammatory bowel disease, complications of ulcerative colitis requiring surgery, or other specific exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis by reducing inflammation and symptoms.

How similar studies have performed: Other studies have shown promise with similar approaches in treating ulcerative colitis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of UC 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 UC assessed by mMS and ES.
3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
4. Participants must meet the contraception recommendations.

Exclusion Criteria:

1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.

Where this trial is running

Los Angeles, California and 175 other locations

+126 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 Ulcerative ColitisDrug TherapyLatitude UC, Latitude Research Program
Last reviewed 2026-06-09 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.