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NCT06254950Not yet recruiting

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, 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
TakedaPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ulcerative Colitis
Drug/Device/Intervention
TAK-279
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Timeline & enrollment
Phase
Phase 2
Start date
Apr 12, 2024
End date
Aug 04, 2027
Enrollment
207 participants
Primary outcome

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

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.

ICD-10 classifications
Ulcerative colitisOther ulcerative colitisUlcerative colitis, unspecifiedArthropathy in ulcerative colitisJuvenile arthritis in ulcerative colitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06254950
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06254950 through Pure Global AI's free database. This Phase 2 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 207 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.