Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Robert Fearn

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 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

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

The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279.

The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  1. TAK-279 Dose 1
  2. TAK-279 Dose 2
  3. TAK-279 Dose 3
  4. Placebo

This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

Keywords

Crohn's Disease, Drug Therapy, Crohn Disease, TAK-279

Eligibility

You can join if…

Open to people ages 18-75

  1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days.
  2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
  3. Participants must have received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both):
    1. Participants must have had an history of inadequate response to, loss of response to, or intolerance to these therapies based on Physician assessment: 6-mercaptopurine or azathioprine, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms).
    2. Have received treatment with ≥1 biologic agents (such as tumor necrosis factor (TNF) antagonists, antibodies to interleukin (IL) -23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as Janus kinase inhibitor (JAKi) or sphingosine-1-phosphate (S1P) receptor modulators).
  4. Participants must meet the contraception recommendations.

You CAN'T join if...

  1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
  2. Have complications of CD that might require surgery during the study.
  3. Participants with a current ostomy.
  4. Participants who have failed 3 or more classes of advanced therapies.

Locations

  • UCI Health not yet accepting patients
    Orange California 92868 United States
  • VVCRD Clinical Research not yet accepting patients
    Garden Grove California 92845-2006 United States
  • United Medical Doctors accepting new patients
    Murrieta California 92563 United States
  • GastroIntestinal BioSciences accepting new patients
    Los Angeles California 90067 United States

Lead Scientist at UC Irvine

  • Robert Fearn
    Assistant Health Sciences Professor, Medicine, School of Medicine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
More about this study
ID
NCT06233461
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 268 study participants
Last Updated