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

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.

Official Title

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

Details

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

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

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Keywords

Ulcerative Colitis, Drug Therapy, Latitude UC, Latitude Research Program, Colitis, Ulcer, 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 UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age.
  2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
  3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
  4. Participants must meet the contraception recommendations.

You CAN'T join if...

  1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
  2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
  3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
  4. Participants who have failed 3 or more classes of advanced therapies.

Locations

  • UCI Health not yet accepting patients
    Orange California 92868 United States
  • GastroIntestinal BioSciences accepting new patients
    Los Angeles California 90067 United States
  • United Medical Doctors accepting new patients
    Murrieta California 92563 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 at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
More about this study
ID
NCT06254950
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 207 study participants
Last Updated