← Back to Search

Corticosteroid

TAK-279 Dose 1 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

~180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,207 Previous Clinical Trials

4,187,922 Total Patients Enrolled

24 Trials studying Ulcerative Colitis

9,117 Patients Enrolled for Ulcerative Colitis

Study DirectorStudy DirectorTakeda

1,216 Previous Clinical Trials

499,467 Total Patients Enrolled

24 Trials studying Ulcerative Colitis

9,670 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial specifically enroll individuals who are above the age of 50?

"Enrollment in this research study is open to individuals aged between 18 and 75 years. There are a total of 78 trials dedicated to participants under the age of 18, as well as 355 trials focused on patients over the age of 65."

Answered by AI

Are potential participants still able to enroll in this ongoing trial?

"Affirmative, information provided on clinicaltrials.gov indicates that this investigation is presently in search of participants. The study was initially made available on March 29th, 2024 and most recently amended on April 24th, 2024. A total of 207 individuals are sought from a network of 105 different sites for enrollment."

Answered by AI

Which demographic of individuals would be ideal candidates for participation in this clinical study?

"Individuals aged between 18 and 75 years with a confirmed diagnosis of ulcerative colitis are eligible for participation in this study, which plans to enroll a total of 207 participants."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"At present, there are 105 active enrollment sites for this trial. These include key locations in Los Angeles, Murrieta, Naples, and numerous other centers nationwide. To optimize convenience for participants, selecting the site nearest to you is recommended to reduce travel requirements upon enrollment."

Answered by AI

What is the safety profile of TAK-279 Dose 1 in individuals receiving treatment?

"In this Phase 2 trial, the safety rating for TAK-279 Dose 1 is graded as a 2 by our team at Power. This indicates that while there exists some safety data, efficacy evidence is currently lacking."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06254950.

All > Paid Studies Houston > Paid Studies Pasadena