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NCT06254950 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Ulcerative Colitis, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 20
- Study locations
NCT06254950: Recruiting Phase 2 study of Ulcerative Colitis, sponsored by Takeda.
NCT06254950 is a Phase 2 study of Ulcerative Colitis that is actively recruiting participants, run by Takeda. The registered enrollment target is 207 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06254950, a Phase 2 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-279
Study Locations (20)
Florida
- West Central Gastroenterology, LLP, d/b/a/ Gastro Florida - Clearwater
- Auzmer Research - Lakeland
- GI PROS, Inc. - Naples
- USF Health Morsani Center for Advanced Healthcare - Tampa
California
- GastroIntestinal BioSciences - Los Angeles
- United Medical Doctors - Murrieta
Georgia
- Emory University Hospital, The Emory Clinic - Atlanta
- Atlanta Center For Gastroenterology, P.C. - Decatur
Texas
- Novel Research, LLC - Bellaire
- Tyler Research Institute, LLC - Tyler
South Australia
- Flinders Medical Centre - Bedford Park
- The Queen Elizabeth Hospital - Woodville
Kentucky
- University Of Louisville - Louisville
Maryland
- Woodholme Gastroenterology Associates - Glen Burnie
Nevada
- Las Vegas Medical Research - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2024-03-29 |
| Est. Completion | 2027-08-04 |
| Phase | Phase 2 |
What NCT06254950 shows while recruiting
NCT06254950 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06254950 names 20 study sites across 13 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06254950 about?
NCT06254950 is a clinical study titled "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 caps...
What is the current status of trial NCT06254950?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2024-03-29. Estimated completion is 2027-08-04.
What conditions does trial NCT06254950 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06254950?
The interventions under investigation include: Placebo (DRUG), TAK-279 (DRUG).
Who is sponsoring clinical trial NCT06254950?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06254950 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06254950's enrollment target sits among peer trials
207 42nd of 122 higher than 81 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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