A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: TAK-279; Drug: Placebo

• Registration Number: NCT06254950
• Lead Sponsor: Takeda

Brief Summary

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.

The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).

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

Detailed Description

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

1. TAK-279 Dose 1

2. TAK-279 Dose 2

3. Placebo

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Study Start: 2024-03-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-09-30
• Study Completion: 2027-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-279 Dose 1	TAK-279	TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
TAK-279 Dose 2	TAK-279	TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
Placebo	TAK-279	TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.
Placebo	Placebo	TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)	Week 12	The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12	Baseline and Week 12	The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)	Baseline, Week 12	Clinical response defined as reduction from baseline in mMS of ≥2 points and ≥30% from baseline and a decrease from baseline in the RB subscore of ≥1 point or an absolute RB subscore of ≤1 point at Week 12.
Percentage of Participants Achieving Symptomatic Remission at Week 12	Week 12	Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1.
Percentage of Participants Achieving Endoscopic Improvement at Week 12	Week 12	Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability).
Percentage of Participants Achieving Endoscopic Remission at Week 12	Week 12	Endoscopic remission defined as a modified Mayo ES of 0.
Percentage of Participants With no Bowel Urgency at Week 12	Week 12	Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.
Percentage of Participants With no Abdominal Pain at Week 12	Week 12	Abdominal pain measured by abdominal pain eDiary item at Week 12.
Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at Week 12	Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.
Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12	Baseline and Week 12	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.

Trial Locations

Locations (176)

GastroIntestinal BioSciences; 🇺🇸 Los Angeles, California, United States

United Medical Doctors; 🇺🇸 Murrieta, California, United States

UCI Health; 🇺🇸 Orange, California, United States

West Central Gastroenterology, LLP, d/b/a/ Gastro Florida; 🇺🇸 Clearwater, Florida, United States

Auzmer Research; 🇺🇸 Lakeland, Florida, United States

GI PROS, Inc.; 🇺🇸 Naples, Florida, United States

USF Health Morsani Center for Advanced Healthcare; 🇺🇸 Tampa, Florida, United States

Emory University Hospital, The Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Atlanta Center For Gastroenterology, P.C.; 🇺🇸 Decatur, Georgia, United States

Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

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