๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-25

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 (NCT06233461)

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

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Takeda

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: United Medical Doctors โ€” Murrieta, California

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (190 Sites)

Showing the first 25 of 190 sites.

  • United Medical Doctors โ€” Murrieta, California
  • UCI Health โ€” Orange, California
  • West Central Gastroenterology, LLP, d/b/a/ Gastro Florida โ€” Clearwater, Florida
  • Auzmer Research โ€” Lakeland, Florida
  • Wellness Clinical Research โ€” Miami Lakes, Florida
  • GI PROS, Inc. โ€” Naples, Florida
  • AdventHealth (Florida Hospital) Medical Group โ€” Orlando, Florida
  • USF Health Morsani Center for Advanced Healthcare โ€” Tampa, Florida
  • Emory University Hospital, The Emory Clinic โ€” Atlanta, Georgia
  • Atlanta Center For Gastroenterology, P.C. โ€” Decatur, Georgia
  • The University of Iowa Hospitals & Clinics โ€” Iowa City, Iowa
  • University of Kansas Medical Center โ€” Kansas City, Kansas
  • University Of Louisville โ€” Louisville, Kentucky
  • Woodholme Gastroenterology Associates โ€” Glen Burnie, Maryland
  • BVL Clinical Research โ€” Liberty, Missouri
  • Las Vegas Medical Research โ€” Las Vegas, Nevada
  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) โ€” New York, New York
  • Rochester Clinical Research โ€” Rochester, New York
  • Great Lakes Gastroenterology Research, LLC โ€” Mentor, Ohio
  • University Gastroenterology Providence โ€” Providence, Rhode Island
  • Gastroenterology Associates, PA โ€” Greenville, South Carolina
  • Novel Research, LLC โ€” Bellaire, Texas
  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance โ€” Fort Worth, Texas
  • One of a Kind Clinical research Center TX LLC โ€” Kingwood, Texas
  • TDDC dba Alliance Research โ€” Mansfield, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 825-3327

Email: medinfoUS@takeda.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Crohn's Disease clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—