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

ClinicalTrials.gov ID: NCT06233461

Public ClinicalTrials.gov record NCT06233461. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 27, 2026, 1:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06233461
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Takeda; Industry
Enrollment: 268 participants

Conditions and interventions

Conditions

Crohn's Disease

Interventions

TAK-279 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 5, 2024 (Actual)
Primary completion: Feb 17, 2027 (Estimated)
Completion: Jul 23, 2027 (Estimated)
Last update posted: Sep 25, 2026

2024 – 2027

United States locations

U.S. sites: 30
U.S. states: 16
U.S. cities: 30

Facility	City	State	ZIP	Site status
United Medical Doctors	Murrieta	California	92563	Recruiting
UCI Health	Orange	California	92868	Recruiting
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida	Clearwater	Florida	33762	Recruiting
Auzmer Research	Lakeland	Florida	33813	Recruiting
Wellness Clinical Research	Miami Lakes	Florida	33016	Recruiting
GI PROS, Inc.	Naples	Florida	34102	Recruiting
AdventHealth (Florida Hospital) Medical Group	Orlando	Florida	32804	Not yet recruiting
USF Health Morsani Center for Advanced Healthcare	Tampa	Florida	33612	Recruiting
Emory University Hospital, The Emory Clinic	Atlanta	Georgia	30322	Recruiting
Atlanta Center For Gastroenterology, P.C.	Decatur	Georgia	30033	Recruiting
The University of Iowa Hospitals & Clinics	Iowa City	Iowa	52242	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	66160	Recruiting
University Of Louisville	Louisville	Kentucky	40202	Recruiting
Woodholme Gastroenterology Associates	Glen Burnie	Maryland	21061	Recruiting
BVL Clinical Research	Liberty	Missouri	64068	Recruiting
Las Vegas Medical Research	Las Vegas	Nevada	89128	Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)	New York	New York	10029	Recruiting
Rochester Clinical Research, Inc	Rochester	New York	14609	Not yet recruiting
Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	44060	Recruiting
Hightower Clinical - SSM Health	Oklahoma City	Oklahoma	73102	Completed
University Gastroenterology Providence	Providence	Rhode Island	02904	Recruiting
Gastroenterology Associates, PA	Greenville	South Carolina	29615	Recruiting
Novel Research, LLC	Bellaire	Texas	77401	Recruiting
TDDC - Baylor University Medical Center Gaston Ave	Dallas	Texas	75246	Completed
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance	Fort Worth	Texas	76104	Completed
One of a Kind Clinical research Center TX LLC	Kingwood	Texas	77339	Recruiting
TDDC dba Alliance Research	Mansfield	Texas	76063	Completed
Southern Star Research Institute, LLC	San Antonio	Texas	78229	Recruiting
Tyler Research Institute, LLC	Tyler	Texas	75701	Recruiting
University of Washington Medical Center	Seattle	Washington	98195	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06233461, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 25, 2026 · Synced Oct 27, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06233461 live on ClinicalTrials.gov.

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