Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Robert Fearn (uci)

Description

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 medical 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.

Official Title

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

Details

Keywords

Crohn's Disease, Drug Therapy, Latitude CD, Latitude Research Program, Crohn Disease, TAK-279

Eligibility

Locations

  • UCI Health accepting new patients
    Orange California 92868 United States
  • GastroIntestinal BioSciences accepting new patients
    Los Angeles California 90067 United States

Lead Scientist at University of California Health

  • Robert Fearn (uci)
    Assistant Health Sciences Professor, Medicine, School of Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT06233461
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 268 study participants
Last Updated