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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
Awards & highlights

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

Timeline

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 for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Group II: TAK-279 Dose 1Experimental Treatment1 Intervention
TAK-279, capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Group III: PlaceboPlacebo Group2 Interventions
TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-279
2023
Completed Phase 1
~390

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,227 Previous Clinical Trials
4,222,298 Total Patients Enrolled
25 Trials studying Ulcerative Colitis
9,517 Patients Enrolled for Ulcerative Colitis
Study DirectorStudy DirectorTakeda
1,252 Previous Clinical Trials
504,172 Total Patients Enrolled
25 Trials studying Ulcerative Colitis
10,070 Patients Enrolled for Ulcerative Colitis
~138 spots leftby Sep 2026
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