Recruiting

Phase 2

TAK-279A 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

Sponsor:

Takeda

Code:

NCT06233461

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TAK-279

Placebo

Study Details

Brief 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.

Conditions

Crohn's Disease

Study ID

NCT06233461

Start date

Mar 5, 2024

Status verified date

Sep, 2026

Completion date

Jul 23, 2027

Anticipated

Primary completion date

Feb 17, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of CD 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 CD assessed by SES-CD and CDAI.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.

Exclusion Criteria:

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.

Study Design

Enrollment

268 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-279 Dose 1

Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.

experimental: TAK-279 Dose 2

Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.

experimental: TAK-279 Dose 3

Participants will be randomized to receive TAK-279 Dose 3 capsules orally.

experimental: Placebo

Participants will be randomized to receive TAK-279 placebo-matching capsules orally.

Interventions

TAK-279

TAK-279 capsules.

Placebo

TAK-279 placebo-matching capsules.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327 medinfoUS@takeda.com

Locations

United Medical Doctors

Recruiting

Murrieta, California, United States, 92563

Contacts

Site Contact

951-566-5229 drhongpi@unitedmd.com

Principal Investigator:

John Hong

UCI Health

Recruiting

Orange, California, United States, 92868

Contacts

Site Contact

714-456-5694 rfearn@hs.uci.edu

Principal Investigator:

Robert Fearn

West Central Gastroenterology, LLP, d/b/a/ Gastro Florida

Recruiting

Clearwater, Florida, United States, 33762

Contacts

Site Contact

727-347-0005 lmweiss@gastrofl.com

Principal Investigator:

Lawrence Michael Weiss

Auzmer Research

Recruiting

Lakeland, Florida, United States, 33813

Contacts

Site Contact

208-346-8900 jligeon@auzmer.com

Principal Investigator:

John Ligeon

Wellness Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Site Contact

786-483-7856 lucky@wellnessclinicalresearch.com

Principal Investigator:

Lucky Flores

GI PROS, Inc.

Recruiting

Naples, Florida, United States, 34102

Contacts

Site Contact

239-649-1336 rphillips212@comcast.net

Principal Investigator:

Raymond Phillips

USF Health Morsani Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Contact

msrosari@usf.edu

Principal Investigator:

Michelle Rosario

Emory University Hospital, The Emory Clinic

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Contact

heba.iskandar@emoryhealthcare.org

Principal Investigator:

Heba Iskandar

Atlanta Center For Gastroenterology, P.C.

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Site Contact

404-512-3280 dbrausher@acgaec.com

Principal Investigator:

David Rausher

The University of Iowa Hospitals & Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Contact

319-384-6336 steven-polyak@uiowa.edu

Principal Investigator:

Steven Polyak

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Contact

skapur@kumc.edu

Principal Investigator:

Saurabh Kapur

University Of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Contact

502-852-6991 gerald.dryden@louisville.edu

Principal Investigator:

Gerald Dryden

Woodholme Gastroenterology Associates

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Site Contact

410-863-4899 konwueme@woodholmegi.com

Principal Investigator:

Kenolisa Onwueme

BVL Clinical Research

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Site Contact

816-222-4241 info@BVLresearch.com

Principal Investigator:

Christopher Bartalos

Las Vegas Medical Research

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

Site Contact

702-750-0000 cstone@nevadagastro.com

Principal Investigator:

Christian Stone

Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

Recruiting

New York, New York, United States, 10029

Contacts

Site Contact

917-538-2158 adam.steinlauf@mssm.edu

Principal Investigator:

Adam Steinlauf

Great Lakes Gastroenterology Research, LLC

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Site Contact

440-205-1225 kfriedenberg@thectnx.com

Principal Investigator:

Keith Friedenberg

University Gastroenterology Providence

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Site Contact

lisa.mueller@gialliance.com

Principal Investigator:

Lisa Mueller

Gastroenterology Associates, PA

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Contact

910-488-3857 mbarnesmd@gastroassociates.com

Principal Investigator:

Matthew Barnes

Novel Research, LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Site Contact

281-491-9779 sana@novelresearch.net

Principal Investigator:

Moazzam Sana

One of a Kind Clinical research Center TX LLC

Recruiting

Kingwood, Texas, United States, 77339

Contacts

Site Contact

346-847-9375 sguha@hrgastro.com

Principal Investigator:

Sushovan Guha

Southern Star Research Institute, LLC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Contact

210-581-2812 js_bull@yahoo.com

Principal Investigator:

Jeff Bullock

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

Contacts

Site Contact

903-630-6211 aaron.duvall@iterativehealth.com

Principal Investigator:

George Duvall

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Contact

206-543-3500 leesd@uw.edu

Principal Investigator:

Scott Lee

Heritage Medical Research Clinic - University Of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

Site Contact

(403) 592-5013 christopher.ma@ucalgary.ca

Principal Investigator:

Christopher Ma

Fraser Clinical Trials

Recruiting

New Westminster, British Columbia, Canada, V3L 3W4

Contacts

Site Contact

dr.mindylam.office@gmail.com

Principal Investigator:

Mindy Lam

Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Site Contact

9024736861 jennifer.jones@nshealth.ca

Principal Investigator:

Jennifer Jones

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Site Contact

5196676878 terry.ponich@lhsc.on.ca

Principal Investigator:

Terry Ponich

London Digestive Disease Institute

Recruiting

London, Ontario, Canada, N6K 1M6

Contacts

Site Contact

vjairath@lddi.ca

Principal Investigator:

Vipul Jairath

University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Site Contact

+1 4165865121 hillary.steinhart@sinaihealth.ca

Principal Investigator:

Allan Hillary Steinhart

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Site Contact

5142953671 robert.battat.med@ssss.gouv.qc.ca

Principal Investigator:

Robert Battat

The Research Institute of the McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Site Contact

(514) 934-8309 talat.bessissow@mcgill.ca

Principal Investigator:

Talat Bessissow

More Information

Sponsor

Takeda

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

Drug Therapy
Latitude CD, Latitude Research Program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Takeda on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.