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

Description

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.

Interventions

• TAK-279 (Drug)
  TAK-279 capsules.
• Placebo (Drug)
  TAK-279 placebo-matching capsules.

Eligibility criteria

Conditions

Locations

• 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
• Region Sjaelland Sygehus Nord, Koge Sygehus — Køge, Denmark
• Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau — Chambray-lès-Tours, France
• CHU De Clermont Ferrand - Hopital Estaing — Clermont-Ferrand, France
• Centres Medico-Chirurgicaux Ambroise Pare-Pierre Cherest-Hartmann - Clinique Ambroise Pare — Neuilly-sur-Seine, France
• CHU Nice - Hopital l'Archet 2 — Nice, France
• Hopital Nord Chu Saint-Etienne — Saint-Etienne, France
• Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois — Vandœuvre-lès-Nancy, France
• Universitaetsklinik Frankfurt — Frankfurt, Germany
• Agaplesion Markus Krankenhaus — Frankfurt am Main, Germany
• Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel — Kiel, Germany
• St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen, Germany
• Universitaetsklinikum Mannheim GmbH — Mannheim, Germany
• Universitaetsklinikum Tuebingen — Tübingen, Germany
• University Hospital Of Ulm, Universitatsklinikum Ulm — Ulm, Germany
• University General Hospital of Patras — Pátrai, Achaia, Greece
• Evangelismos Hospital — Athens, Attica, Greece
• University of Athens School of Medicine, Alexandra General Hospital — Athens, Attica, Greece
• University General Hospital of Heraklion — Heraklion, Crete, Greece
• Sotiria General Hospital of Athens — Athens, Greece
• G.N.A. Gennimatas — Athens, Greece
• Clinexpert — Budapest, Hungary
• Semmelweis Egyetem — Budapest, Hungary
• Pannonia Maganorvosi Centrum Kft. — Budapest, Hungary
• PTE KK, Mohacsi Korhaz — Mohács, Hungary
• Assuta Ashdod Medical Center — Ashdod, Israel
• Soroka Mc — Beersheba, Israel
• Digestive Disease Institute, Shaare Zedek Medical Center — Jerusalem, Israel
• Meir Medical Center — Kfar Saba, Israel
• The Chaim Sheba Medical Center — Ramat Gan, Israel
• IRCCS - AOU Policlinico S. Orsola - Malpighi — Bologna, Italy
• Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele — Milan, Italy
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello — Palermo, Italy
• A. Gemelli University Hospital, Catholic University of the Sacred Heart — Roma, Italy
• Azienda Ospedaliera San Camillo Forlanini — Rome, Italy
• IRCCS Istituto clinico humanitas - Humanitas Mirasole spa — Rozzano, Italy
• Sapporo Medical University Hospital — Sapporo, Hokkaido, Japan
• Hyogo Medical University Hospital — Nishinomiya, Hyōgo, Japan
• Iwate Medical University Uchimaru Medical Center — Morioka, Iwate, Japan
• Tohoku University Hospital — Sendai, Miyagi, Japan
• Kansai Medical University Hospital — Hirakata, Osaka, Japan
• Osaka Medical and Pharmaceutical University Hospital — Takatsuki-shi, Osaka, Japan
• Hamamatsu University Hospital — Hamamatsu, Shizuoka, Japan
• The Jikei University Hospital — Minato, Tokyo, Japan
• Kyorin University Hospital — Mitaka, Tokyo, Japan
• Tsujinaka Hospital Kashiwanoha — Chiba, Japan
• Fukuoka University Hospital — Fukuoka, Japan
• Institute of Science Tokyo Hospital — Tokyo, Japan
• Toyama University Hospital — Toyama, Japan
• Zuyderland Medisch Centrum - Sittard-Geleen — Geleen, Limburg, Netherlands
• Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC) — Amsterdam, Netherlands
• St. Elisabeth Ziekenhuis — Tilburg, Netherlands
• Akershus Universitetssykehus HF — Lorenskog, Akershus, Norway
• Oslo Univeristy Hospital Ulleval Hospital — Oslo, Norway
• Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie — Torun, Kujawsko-pomo, Poland
• PlanetMed Sp. z o.o. — Wroclaw, Lower Silesian Voivodeship, Poland
• Centrum Medyczne Melita Medical — Wroclaw, Lower Silesian Voivodeship, Poland
• Panstwowy Instytut Medyczny MSWiA — Warsaw, Masovian Voivodeship, Poland
• Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin, West Pomeranian Voivodeship, Poland
• Manermed Sp. z o.o - CM Medis — Bydgoszcz, Poland
• Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi — Lodz, Poland
• Centrum Medyczne Med-Gastr — Lodz, Poland
• Medrise sp. z o.o — Lublin, Poland
• Solumed Centrum Medyczne — Poznan, Poland
• Centrum Medyczne Medyk Sp. z o.o. Sp. K. — Rzeszów, Poland
• Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland
• Endoskopia Sp. z o.o. — Sopot, Poland
• H-T. Centrum Medyczne Sp. z o.o. Sp.k. — Tychy, Poland
• Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland
• Centrum Badan Klinicznych — Wroclaw, Poland
• Centrum Medyczne Oporow — Wroclaw, Poland
• ETG Zamosc — Zamość, Poland
• AmiCare Sp. z o.o. Sp. k. — Lodz, Łódź Voivodeship, Poland
• Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis — Timișoara, Jud Timis, Romania
• Centrul Medical Valahia — Ploieşti, Prahova, Romania
• Spitalul Euroclinic — Bucharest, Romania
• Clinical Hospital Colentina-Spitalul Clinic Colentina — Bucharest, Romania
• Spital Clinic Dr I Cantacuzino — Bucharest, Romania
• Clinica Medicum — Bucharest, Romania
• Institutul Clinic Fundeni — Bucharest, Romania
• Accout Center, s.r.o.- Gastroenterologicka ambulancia — Šahy, Nitra Region, Slovakia
• Fakultna nemocnica F. D. Roosevelta — Banská Bystrica, Slovakia
• Cliniq s. r. o. — Bratislava, Slovakia
• Endomed — Košice, Slovakia
• Fakultna Nemocnica s poliklinikou Nove Zamky — Nové Zámky, Slovakia
• Yonsei University Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea
• Inje University Haeundae Paik Hospital — Busan, South Korea
• Kosin University Gospel Hospital — Busan, South Korea
• Keimyung University Dongsan Hospital — Daegu, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center (AMC) — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• University Hospital Basel — Basel, Switzerland
• Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern — Bern, Switzerland
• Changhua Christian Hospital — Changhua, Changhua County, Taiwan
• National Taiwan University Hospital (NTUH) — Taipei, Zhongzheng District, Taiwan
• China Medical University Hospital — Taichung, Taiwan
• Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom
• Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust — London, E1 2at, United Kingdom
• South Eastern Health and Social Care Trust - The Ulster Hospital — Belfast, United Kingdom
• St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom
• NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust — London, United Kingdom