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
Recruiting · NCT06233461 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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.
Where it is running
60 locations listed across 15 US states.
- United Medical Doctors - Murrieta, California, United States
- UCI Health - Orange, California, United States
- West Central Gastroenterology, LLP, d/b/a/ Gastro Florida - Clearwater, Florida, United States
- Auzmer Research - Lakeland, Florida, United States
- Wellness Clinical Research - Miami Lakes, Florida, United States
- GI PROS, Inc. - Naples, Florida, United States
- AdventHealth (Florida Hospital) Medical Group - Orlando, Florida, United States
- USF Health Morsani Center for Advanced Healthcare - Tampa, Florida, United States
- Emory University Hospital, The Emory Clinic - Atlanta, Georgia, United States
- Atlanta Center For Gastroenterology, P.C. - Decatur, Georgia, United States
- The University of Iowa Hospitals & Clinics - Iowa City, Iowa, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- University Of Louisville - Louisville, Kentucky, United States
- Woodholme Gastroenterology Associates - Glen Burnie, Maryland, United States
- BVL Clinical Research - Liberty, Missouri, United States
- Las Vegas Medical Research - Las Vegas, Nevada, United States
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) - New York, New York, United States
- Rochester Clinical Research - Rochester, New York, United States
- Great Lakes Gastroenterology Research, LLC - Mentor, Ohio, United States
- University Gastroenterology Providence - Providence, Rhode Island, United States
- Gastroenterology Associates, PA - Greenville, South Carolina, United States
- Novel Research, LLC - Bellaire, Texas, United States
- Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Fort Worth, Texas, United States
- One of a Kind Clinical research Center TX LLC - Kingwood, Texas, United States
- TDDC dba Alliance Research - Mansfield, Texas, United States
- Southern Star Research Institute, LLC - San Antonio, Texas, United States
- Tyler Research Institute, LLC - Tyler, Texas, United States
- University of Washington Medical Center - Seattle, Washington, United States
- Aalborg Hospital - Aalborg, Denmark
- Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC) - Amsterdam, Netherlands
- Sotiria General Hospital of Athens - Athens, Greece
- G.N.A. Gennimatas - Athens, Greece
- Fakultna nemocnica F. D. Roosevelta - Banská Bystrica, Slovakia
- University Hospital Basel - Basel, Switzerland
- Soroka Mc - Beersheba, Israel
- South Eastern Health and Social Care Trust - The Ulster Hospital - Belfast, United Kingdom
- Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern - Bern, Switzerland
- IRCCS - AOU di Bologna - SantOrsola Malpighi - Bologna, Italy
- Cliniq s. r. o. - Bratislava, Slovakia
- SurGal Clinic SRO - Brno, Czechia
- Vojenska Nemocnice Brno - Brno, Czechia
- University Hospital Brno - Brno, Czechia
- CHU Saint-Pierre - Porte de Hal - Brussels, Belgium
- Clinical Hospital Colentina-Spitalul Clinic Colentina - Bucharest, Romania
- Clinica Medicum - Bucharest, Romania
- Spital Clinic Dr I Cantacuzino - Bucharest, Romania
- Institutul Clinic Fundeni - Bucharest, Romania
- Spitalul Euroclinic - Bucharest, Romania
- Clinexpert - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Pannonia Maganorvosi Centrum Kft. - Budapest, Hungary
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Kosin University Gospel Hospital - Busan, South Korea
- Manermed Sp. z o.o - CM Medis - Bydgoszcz, Poland
- Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau - Chambray-lès-Tours, France
- Tsujinaka Hospital Kashiwanoha - Chiba, Japan
- CHU De Clermont Ferrand - Hopital Estaing - Clermont-Ferrand, France
- Keimyung University Dongsan Hospital - Daegu, South Korea
- Northern Hospital Epping - Epping, Australia
- Sydvestjysk Region/Esbjerg Hospital - Esbjerg, Denmark
Showing 60 of 190 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →