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RECRUITING
NCT06233461
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

TAK-279

TAK-279 capsules.

DRUG

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

And 101 more locations on ClinicalTrials.gov