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Corticosteroid

TAK-279 for Ulcerative Colitis

Phase 2

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES

Be older than 18 years old

Must not have

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 with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

This trial aims to see if TAK-279 can reduce bowel inflammation and symptoms compared to a placebo. Participants will take TAK-279 or placebo capsules for 3 months and then all participants will

Who is the study for?

This trial is for adults aged 18-75 with moderately to severely active ulcerative colitis (UC) who haven't responded well to other UC treatments. They must have been diagnosed at least 30 days prior and meet specific medical criteria for disease activity. Participants are also required to follow contraception guidelines.

What is being tested?

The study tests if TAK-279 can reduce bowel inflammation in UC patients compared to a placebo. Initially, participants will be randomly assigned to receive either TAK-279 or a placebo for 12 weeks, after which all participants will take TAK-279 for up to one year.

What are the potential side effects?

While the specific side effects of TAK-279 aren't listed here, common issues may include digestive discomfort, potential allergic reactions, headaches, fatigue, and possibly increased risk of infection due to immune system modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ulcerative colitis is moderate to severe, confirmed by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current ileostomy or colostomy.

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I have UC complications that might need surgery during the study.

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I have tried and not responded to 3 different types of advanced cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-279 Dose 2Experimental Treatment1 Intervention

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.

Group II: TAK-279 Dose 1Experimental Treatment1 Intervention

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.

Group III: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-279

2023

Completed Phase 1

~390

0 / 4Eligibility criteria met