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
NCT ID: NCT06233461
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
268 participants
INTERVENTIONAL
2024-03-05
2027-07-23
Brief Summary
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The participants will be treated with TAK-279 for 52 weeks (1 year).
During the study, participants will visit their study clinic 15 times.
Detailed Description
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The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. TAK-279 Dose 3
4. Placebo
This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TAK-279 Dose 1
Participants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
TAK-279
TAK-279 capsules.
Placebo
TAK-279 placebo-matching capsules.
TAK-279 Dose 2
Participants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
TAK-279
TAK-279 capsules.
Placebo
TAK-279 placebo-matching capsules.
TAK-279 Dose 3
Participants will be randomized to receive TAK-279 Dose 3 capsules orally.
TAK-279
TAK-279 capsules.
Placebo
Participants will be randomized to receive TAK-279 placebo-matching capsules orally.
Placebo
TAK-279 placebo-matching capsules.
Interventions
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TAK-279
TAK-279 capsules.
Placebo
TAK-279 placebo-matching capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
3. 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
2. Have complications of CD that might require surgery during the study.
3. Participants with a current ostomy.
4. Participants who have failed 3 or more classes of advanced therapies.
18 Years
75 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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GastroIntestinal BioSciences
Los Angeles, California, United 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
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 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
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
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
Sydney, 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
Melbourne, 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
UMBAL 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
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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
Shenyang, Liaoning, 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
NH Hospital
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
Endohope Clinic
Prague, , Czechia
Axon Clinical s.r.o.
Prague, , Czechia
Masaryk Hospital
Ústí nad Labem, , Czechia
Odense Universitetshospital (OUH) (Odense University Hospital)
Odense, Region Syddanmark, Denmark
Aalborg Hospital
Aalborg, , Denmark
Sydvestjysk Region/Esbjerg Hospital
Esbjerg, , 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
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 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
Mohacsi Korhaz
Mohács, , Hungary
Soroka Mc
Beersheba, , Israel
Digestive Disease Institute, Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
Ramat Gan, , Israel
The Chaim Sheba Medical Centre
Tel Aviv, , Israel
IRCCS - AOU di Bologna - SantOrsola Malpighi
Bologna, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena - Clinica Mangiagalli
Milan, , 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 College 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 University Hospital
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
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, Poland
PlanetMed Sp. z o.o.
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
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
Rzeszów, , Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Centrum Badan Klinicznych
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
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
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
Accout Center, s.r.o.- Gastroenterologicka ambulancia
Šahy, , 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
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
Countries
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Central Contacts
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Facility Contacts
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Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Site Contact
Role: primary
Related Links
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To obtain more information about this study, click this link
Other Identifiers
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2023-506704-14-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2051240050
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-279-CD-2001
Identifier Type: -
Identifier Source: org_study_id