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NCT06233461

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease
Takeda·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Crohn's Disease
Drug/Device/Intervention
TAK-279
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Timeline & enrollment
Phase
Phase 2
Start date
Mar 06, 2024
End date
Jul 23, 2027
Enrollment
268 participants
Primary outcome

Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

Summary

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any
 part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279
 versus placebo in participants with moderately to severely active Crohn's disease (CD). The
 main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel
 inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment.
 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. An endoscopy will be used to
 check the bowel for inflammation.
 
 The participants will be treated with TAK-279 for 52 weeks (1 year).
 
 During the study, participants will visit their study clinic 15 times.t

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06233461
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06233461 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 Crohn's Disease. Target enrollment is 268 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.