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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 - Trial NCT06254950

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.

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NCT06254950
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06254950
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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

Study Focus

Ulcerative Colitis

TAK-279

Interventional

drug

Sponsor & Location

Takeda

Timeline & Enrollment

Phase 2

Apr 12, 2024

Aug 04, 2027

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 colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06254950

Non-Device Trial