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
Takeda · NCT06233461
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 268
- US sites recruiting
- 24
- Study start
- March 5, 2024
- Record last updated
- September 25, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: TAK-279; Placebo
Conditions: Crohn's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
- Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
- 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
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- Have complications of CD that might require surgery during the study.
- Participants with a current ostomy.
- Participants who have failed 3 or more classes of advanced therapies.
Recruiting US locations
United Medical Doctors
Murrieta, CA 92563
Site contact: Site Contact · 951-566-5229 · drhongpi@unitedmd.com
UCI Health
Orange, CA 92868
Site contact: Site Contact · 714-456-5694 · rfearn@hs.uci.edu
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, FL 33762
Site contact: Site Contact · 727-347-0005 · lmweiss@gastrofl.com
Auzmer Research
Lakeland, FL 33813
Site contact: Site Contact · 208-346-8900 · jligeon@auzmer.com
Wellness Clinical Research
Miami Lakes, FL 33016
Site contact: Site Contact · 786-483-7856 · lucky@wellnessclinicalresearch.com
GI PROS, Inc.
Naples, FL 34102
Site contact: Site Contact · 239-649-1336 · rphillips212@comcast.net
USF Health Morsani Center for Advanced Healthcare
Tampa, FL 33612
Site contact: Site Contact · msrosari@usf.edu
Emory University Hospital, The Emory Clinic
Atlanta, GA 30322
Site contact: Site Contact · heba.iskandar@emoryhealthcare.org
Atlanta Center For Gastroenterology, P.C.
Decatur, GA 30033
Site contact: Site Contact · 404-512-3280 · dbrausher@acgaec.com
The University of Iowa Hospitals & Clinics
Iowa City, IA 52242
Site contact: Site Contact · 319-384-6336 · steven-polyak@uiowa.edu
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Site Contact · skapur@kumc.edu
University Of Louisville
Louisville, KY 40202
Site contact: Site Contact · 502-852-6991 · gerald.dryden@louisville.edu
Woodholme Gastroenterology Associates
Glen Burnie, MD 21061
Site contact: Site Contact · 410-863-4899 · konwueme@woodholmegi.com
BVL Clinical Research
Liberty, MO 64068
Site contact: Site Contact · 816-222-4241 · info@BVLresearch.com
Las Vegas Medical Research
Las Vegas, NV 89128
Site contact: Site Contact · 702-750-0000 · cstone@nevadagastro.com
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, NY 10029
Site contact: Site Contact · 917-538-2158 · adam.steinlauf@mssm.edu
Great Lakes Gastroenterology Research, LLC
Mentor, OH 44060
Site contact: Site Contact · 440-205-1225 · kfriedenberg@thectnx.com
University Gastroenterology Providence
Providence, RI 02904
Site contact: Site Contact · lisa.mueller@gialliance.com
Gastroenterology Associates, PA
Greenville, SC 29615
Site contact: Site Contact · 910-488-3857 · mbarnesmd@gastroassociates.com
Novel Research, LLC
Bellaire, TX 77401
Site contact: Site Contact · 281-491-9779 · sana@novelresearch.net
One of a Kind Clinical research Center TX LLC
Kingwood, TX 77339
Site contact: Site Contact · 346-847-9375 · sguha@hrgastro.com
Southern Star Research Institute, LLC
San Antonio, TX 78229
Site contact: Site Contact · 210-581-2812 · js_bull@yahoo.com
Tyler Research Institute, LLC
Tyler, TX 75701
Site contact: Site Contact · 903-630-6211 · aaron.duvall@iterativehealth.com
University of Washington Medical Center
Seattle, WA 98195
Site contact: Site Contact · 206-543-3500 · leesd@uw.edu
Study contacts (from the official record)
- Takeda Contact · +1-877-825-3327 · medinfoUS@takeda.com