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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
Sponsor: Takeda
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2024-03-05
Completion Date
2027-07-23
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
TAK-279
TAK-279 capsules.
Placebo
TAK-279 placebo-matching capsules.
Locations (201)
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, Inc
Rochester, New York, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Hightower Clinical - SSM Health
Oklahoma City, Oklahoma, 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
TDDC - Baylor University Medical Center Gaston Ave
Dallas, 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
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Mater Cancer Care Centre-Mater Health Services
South Brisbane, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Western Health/Footscray Hospital
Footscray, Victoria, Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Northern Hospital Epping
Epping, Australia
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
Nedlands, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium
CHU Saint-Pierre - Porte de Hal
Brussels, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, Belgium
L2 IP - Instituto de Pesquisas Clinicas LTDA
Brasília, Federal District, Brazil
Galileo Medical Research
Juiz de Fora, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
UniversidadeEstadualde Campinas - UNICAMP
Campinas, São Paulo, Brazil
Centro de Estudos Clnicos do Interior Paulista (CECIP)
Jaú, São Paulo, Brazil
Ribeiralo Preto Medical School, University of Salo Paulo
Ribeirão Preto, São Paulo, Brazil
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, Brazil
Solare Trials
São Paulo, Brazil
UMHAT Kaspela
Plovdiv, Bulgaria
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
Sliven, Bulgaria
Acibadem City clinic Tokuda hospital
Sofia, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
Sofia, Bulgaria
Acibadem City Clinic Mladost Hospital
Sofia, Bulgaria
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
Halifax, Nova Scotia, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
London Digestive Disease Institute
London, Ontario, Canada
University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Research Institute of the McGill University Health Center
Montreal, Quebec, Canada
Chongqing General Hospital
Chongqing, Chongqing Sheng, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University (SYSU) - The First Affiliated Hospital
Guangzhou, Guangdong, China
Huizhou First Hospital
Huizhou, Guangdong, China
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
Shenyang, Liaoning, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
Guangzhou, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, China
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, China
Nemocnice Horovice (NH Hospital a.s.)
Hořovice, Central Bohemia, Czechia
SurGal Clinic SRO
Brno, Czechia
Vojenska Nemocnice Brno
Brno, Czechia
University Hospital Brno
Brno, Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
EndoArt
Ostrava, Czechia
Fakultni Nemocnice Ostrava (FNO)
Ostrava-Poruba, Czechia
Gastromedic s.r.o
Pardubice, Czechia
Axon Clinical s.r.o.
Prague, Czechia
Endohope Clinic
Prague, Czechia
Masaryk Hospital
Ústí nad Labem, Czechia
Odense Universitetshospital (OUH) (Odense University Hospital)
Odense, Region Syddanmark, Denmark
Sydvestjysk Region/Esbjerg Hospital
Esbjerg, Denmark
Aalborg Hospital
Gistrup, Denmark
Hillerod Hospital, Hilleroed Sygehus
Hillerød, Denmark
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, Denmark