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NCT Number: NCT06254950

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Concord Repatriation General Hospital, Sydney, New South Wales, Australia

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About this study

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 -

  • TAK-279 Dose 1
  • TAK-279 Dose 2
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
  • 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.
  • Participants must meet the contraception recommendations.

Exclusion criteria

  • 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).
  • Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
  • Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
  • Participants who have failed 3 or more classes of advanced therapies.

Treatment and study plan

TAK-279

Drug

TAK-279 capsules.

Other names: Zasocitinib

Placebo

Drug

TAK-279 placebo-matching capsules.

Primary outcomes

  1. Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)

    Time frame: 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 outcomes

  1. Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)

    Time frame: 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.

  2. Percentage of Participants Achieving Symptomatic Remission at Week 12

    Time frame: Week 12

    Symptomatic remission is defined as a RB subscore of 0 and SF subscore of ≤1.

  3. Percentage of Participants Achieving Endoscopic Improvement at Week 12

    Time frame: Week 12

    Endoscopic improvement defined as a modified Mayo ES of ≤1 (score of 1 modified to exclude friability).

  4. Percentage of Participants Achieving Endoscopic Remission at Week 12

    Time frame: Week 12

    Endoscopic remission defined as a modified Mayo ES of 0.

  5. Percentage of Participants With no Bowel Urgency at Week 12

    Time frame: Week 12

    Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.

  6. Percentage of Participants With no Abdominal Pain at Week 12

    Time frame: Week 12

    Abdominal pain measured by abdominal pain eDiary item at Week 12.

  7. Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score ≥170 at Week 12

    Time frame: 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.

  8. Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12

    Time frame: 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.

  9. Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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