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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

NCT06233461 · Takeda
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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
About this study
The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. 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.
Eligibility criteria
Inclusion Criteria: 1. 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. 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: 1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis. 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.
Study design
Enrollment target: 268 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-03-05
Estimated completion: 2027-07-23
Last updated: 2026-04-13
Interventions
Drug: TAK-279Drug: Placebo
Primary outcomes
  • Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 (Week 12)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (194)
GastroIntestinal BioSciencesRecruiting
Los Angeles, California, United States
United Medical DoctorsRecruiting
Murrieta, California, United States
UCI HealthRecruiting
Orange, California, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro FloridaRecruiting
Clearwater, Florida, United States
Auzmer ResearchRecruiting
Lakeland, Florida, United States
Wellness Clinical ResearchRecruiting
Miami Lakes, Florida, United States
GI PROS, Inc.Recruiting
Naples, Florida, United States
AdventHealth (Florida Hospital) Medical GroupNot Yet Recruiting
Orlando, Florida, United States
USF Health Morsani Center for Advanced HealthcareRecruiting
Tampa, Florida, United States
Emory University Hospital, The Emory ClinicRecruiting
Atlanta, Georgia, United States
Atlanta Center For Gastroenterology, P.C.Recruiting
Decatur, Georgia, United States
The University of Iowa Hospitals & ClinicsRecruiting
Iowa City, Iowa, United States
University of Kansas Medical CenterNot Yet Recruiting
Kansas City, Kansas, United States
University Of LouisvilleRecruiting
Louisville, Kentucky, United States
Woodholme Gastroenterology AssociatesRecruiting
Glen Burnie, Maryland, United States
BVL Clinical ResearchRecruiting
Liberty, Missouri, United States
Las Vegas Medical ResearchRecruiting
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)Recruiting
New York, New York, United States
Rochester Clinical ResearchRecruiting
Rochester, New York, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
University Gastroenterology ProvidenceRecruiting
Providence, Rhode Island, United States
Gastroenterology Associates, PARecruiting
Greenville, South Carolina, United States
Novel Research, LLCRecruiting
Bellaire, Texas, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI AllianceRecruiting
Fort Worth, Texas, United States
One of a Kind Clinical research Center TX LLCNot Yet Recruiting
Kingwood, Texas, United States
TDDC dba Alliance ResearchRecruiting
Mansfield, Texas, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
Concord Repatriation General HospitalRecruiting
Sydney, New South Wales, Australia
Mater Cancer Care Centre-Mater Health ServicesRecruiting
South Brisbane, Queensland, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
The Queen Elizabeth HospitalRecruiting
Woodville, South Australia, Australia
Western Health/Footscray HospitalRecruiting
Melbourne, Victoria, Australia
Harry Perkins Medical Research Institute Fiona Stanley HospitalRecruiting
Murdoch, Western Australia, Australia
Royal Perth HospitalRecruiting
Perth, Western Australia, Australia
Northern Hospital EppingRecruiting
Epping, Australia
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer CentreRecruiting
Nedlands, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis BrusselRecruiting
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium
CHU Saint-Pierre - Porte de HalRecruiting
Brussels, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
L2 IP - Instituto de Pesquisas Clinicas LTDANot Yet Recruiting
Brasília, Federal District, Brazil
Galileo Medical ResearchNot Yet Recruiting
Juiz de Fora, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de BotucatuNot Yet Recruiting
Botucatu, São Paulo, Brazil
UniversidadeEstadualde Campinas - UNICAMPNot Yet Recruiting
Campinas, São Paulo, Brazil
Centro de Estudos Clnicos do Interior Paulista (CECIP)Not Yet Recruiting
Jaú, São Paulo, Brazil
Ribeiralo Preto Medical School, University of Salo PauloNot Yet Recruiting
Ribeirão Preto, São Paulo, Brazil
Irmandade da Santa Casa da Misericordia de SantosNot Yet Recruiting
Santos, São Paulo, Brazil
Solare TrialsNot Yet Recruiting
São Paulo, Brazil
UMBAL KaspelaRecruiting
Plovdiv, Bulgaria
Multi-Profile Hospital for Active Treatment (MHAT) Hadji DimitarRecruiting
Sliven, Bulgaria
Acibadem City clinic Tokuda hospitalRecruiting
Sofia, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOODRecruiting
Sofia, Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)Recruiting
Sofia, Bulgaria
Acibadem City Clinic Mladost HospitalRecruiting
Sofia, Bulgaria
Heritage Medical Research Clinic - University Of CalgaryRecruiting
Calgary, Alberta, Canada
Fraser Clinical TrialsRecruiting
New Westminster, British Columbia, Canada
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences CentreRecruiting
Halifax, Nova Scotia, Canada
London Health Sciences Centre - University HospitalRecruiting
London, Ontario, Canada
London Health Sciences Centre - Victoria HospitalRecruiting
London, Ontario, Canada
University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research InstituteRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de MontrealRecruiting
Montreal, Quebec, Canada
The Research Institute of the McGill University Health CenterRecruiting
Montreal, Quebec, Canada
Chongqing General HospitalRecruiting
Chongqing, Chongqing Sheng, China
Zhongshan Hospital Xiamen UniversityRecruiting
Xiamen, Fujian, China
Sun Yat-sen University (SYSU) - The First Affiliated HospitalRecruiting
Guangzhou, Guangdong, China
Huizhou First HospitalNot Yet Recruiting
Huizhou, Guangdong, China
Wuhan University - Renmin Hospital (Hubei General Hospital)Not Yet Recruiting
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
The Second People's Hospital of ChangzhouNot Yet Recruiting
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow UniversityNot Yet Recruiting
Suzhou, Jiangsu, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang CampusRecruiting
Shenyang, Liaoning, China
Shanghai East HospitalNot Yet Recruiting
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)Recruiting
Guangzhou, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)Recruiting
Hangzhou, China
Shanghai Pudong New District Zhoupu HospitalRecruiting
Shanghai, China
The First Affiliated Hospital of Zhejiang Chinese Medical UniversityNot Yet Recruiting
Zhejiang, China
NH HospitalRecruiting
Hořovice, Central Bohemia, Czechia
SurGal Clinic SRORecruiting
Brno, Czechia
Vojenska Nemocnice BrnoRecruiting
Brno, Czechia
University Hospital BrnoRecruiting
Brno, Czechia
Nemocnice Ceske Budejovice, a.s.Recruiting
České Budějovice, Czechia
Hepato-Gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
EndoArtRecruiting
Ostrava, Czechia
Fakultni Nemocnice Ostrava (FNO)Recruiting
Ostrava-Poruba, Czechia
Gastromedic s.r.oRecruiting
Pardubice, Czechia
Endohope ClinicRecruiting
Prague, Czechia
Axon Clinical s.r.o.Recruiting
Prague, Czechia
Masaryk HospitalRecruiting
Ústí nad Labem, Czechia
Odense Universitetshospital (OUH) (Odense University Hospital)Recruiting
Odense, Region Syddanmark, Denmark
Aalborg HospitalRecruiting
Aalborg, Denmark
Sydvestjysk Region/Esbjerg HospitalRecruiting
Esbjerg, Denmark
Hillerod Hospital, Hilleroed SygehusRecruiting
Hillerød, Denmark
Hvidovre Hospital Medicinsk Gastroenterologisk AfdelingRecruiting
Hvidovre, Denmark
Region Sjaelland Sygehus Nord, Koge SygehusRecruiting
Køge, Denmark
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital TrousseauRecruiting
Chambray-lès-Tours, France
CHU De Clermont Ferrand - Hopital EstaingRecruiting
Clermont-Ferrand, France
Hopital l'Archet 2Recruiting
Nice, France
Hopital Nord Chu Saint-EtienneRecruiting
Saint-Etienne, France
Centre Hospitalier Regional Universitaire de Nancy, Hopital BraboisRecruiting
Vandœuvre-lès-Nancy, France
Universitaetsklinik FrankfurtRecruiting
Frankfurt, Germany
Agaplesion Markus KrankenhausRecruiting
Frankfurt am Main, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus KielRecruiting
Kiel, Germany
St. Marien- und St. AnnastiftskrankenhausRecruiting
Ludwigshafen, Germany
Universitaetsklinikum Mannheim GmbHRecruiting
Mannheim, Germany
Universitaetsklinikum TuebingenRecruiting
Tübingen, Germany
University Hospital Of Ulm, Universitatsklinikum UlmRecruiting
Ulm, Germany
University General Hospital of PatrasRecruiting
Pátrai, Achaia, Greece
Evangelismos HospitalRecruiting
Athens, Attica, Greece
University of Athens School of Medicine, Alexandra General HospitalRecruiting
Athens, Attica, Greece
University Hospital of HeraklionRecruiting
Heraklion, Crete, Greece
Sotiria General Hospital of AthensRecruiting
Athens, Greece
G.N.A. GennimatasRecruiting
Athens, Greece
ClinexpertRecruiting
Budapest, Hungary
Semmelweis EgyetemRecruiting
Budapest, Hungary
Pannonia Maganorvosi Centrum Kft.Recruiting
Budapest, Hungary
Mohacsi KorhazRecruiting
Mohács, Hungary
Soroka McRecruiting
Beersheba, Israel
Digestive Disease Institute, Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's HospitalRecruiting
Ramat Gan, Israel
The Chaim Sheba Medical CentreRecruiting
Tel Aviv, Israel
IRCCS - AOU di Bologna - SantOrsola MalpighiRecruiting
Bologna, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena - Clinica MangiagalliRecruiting
Milan, Italy
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San RaffaeleRecruiting
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia CervelloRecruiting
Palermo, Italy
A. Gemelli University Hospital, Catholic University of the Sacred HeartRecruiting
Roma, Italy
Azienda Ospedaliera San Camillo ForlaniniRecruiting
Rome, Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spaRecruiting
Rozzano, Italy
Sapporo Medical University HospitalRecruiting
Sapporo, Hokkaido, Japan
Hyogo Medical University HospitalRecruiting
Nishinomiya, Hyōgo, Japan
Iwate Medical University Uchimaru Medical CenterRecruiting
Morioka, Iwate, Japan
Tohoku University HospitalRecruiting
Sendai, Miyagi, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
Osaka Medical College HospitalRecruiting
Takatsuki-shi, Osaka, Japan
Hamamatsu University HospitalRecruiting
Hamamatsu, Shizuoka, Japan
The Jikei University HospitalRecruiting
Minato, Tokyo, Japan
Kyorin University HospitalRecruiting
Mitaka, Tokyo, Japan
Tsujinaka Hospital KashiwanohaRecruiting
Chiba, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Japan
Institute of Science Tokyo HospitalRecruiting
Tokyo, Japan
Toyama University HospitalRecruiting
Toyama, Japan
Zuyderland Medisch Centrum - Sittard-GeleenRecruiting
Geleen, Limburg, Netherlands
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)Recruiting
Amsterdam, Netherlands
St. Elisabeth ZiekenhuisRecruiting
Tilburg, Netherlands
Akershus University HospitalRecruiting
Lorenskog, Akershus, Norway
Oslo Univeristy Hospital Ulleval HospitalRecruiting
Oslo, Norway
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety LekarskieRecruiting
Torun, Kujawsko-pomo, Poland
Centrum Medyczne Melita MedicalRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
PlanetMed Sp. z o.o.Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiARecruiting
Warsaw, Masovian Voivodeship, Poland
Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting
Szczecin, West Pomeranian Voivodeship, Poland
Manermed Sp. z o.o - CM MedisRecruiting
Bydgoszcz, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w LodziRecruiting
Lodz, Poland
Centrum Medyczne Med-GastrRecruiting
Lodz, Poland
Medrise sp. z o.oRecruiting
Lublin, Poland
Centrum Medyczne Medyk Sp. z o.o. Sp. K.Recruiting
Rzeszów, Poland
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
H-T. Centrum Medyczne Sp. z o.o. Sp.k.Recruiting
Tychy, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Centrum Badan KlinicznychRecruiting
Wroclaw, Poland
ETG ZamoscRecruiting
Zamość, Poland
AmiCare Sp. z o.o. Sp. k.Recruiting
Lodz, Łódź Voivodeship, Poland
Policlinica Algomed: Centrul De Gastroenterologie Dr. GoldisRecruiting
Timișoara, Jud Timis, Romania
Clinical Hospital Colentina-Spitalul Clinic ColentinaRecruiting
Bucharest, Romania
Clinica MedicumRecruiting
Bucharest, Romania
Spital Clinic Dr I CantacuzinoRecruiting
Bucharest, Romania
Institutul Clinic FundeniRecruiting
Bucharest, Romania
Spitalul EuroclinicRecruiting
Bucharest, Romania
Fakultna nemocnica F. D. RooseveltaRecruiting
Banská Bystrica, Slovakia
Cliniq s. r. o.Recruiting
Bratislava, Slovakia
EndomedRecruiting
Košice, Slovakia
Fakultna Nemocnica s poliklinikou Nove ZamkyRecruiting
Nové Zámky, Slovakia
Accout Center, s.r.o.- Gastroenterologicka ambulanciaRecruiting
Šahy, Slovakia
Yonsei University Wonju Severance Christian HospitalRecruiting
Wŏnju, Gangwon-do, South Korea
Inje University Haeundae Paik HospitalRecruiting
Busan, South Korea
Kosin University Gospel HospitalRecruiting
Busan, South Korea
Keimyung University Dongsan HospitalRecruiting
Daegu, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center (AMC)Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
University Hospital BaselRecruiting
Basel, Switzerland
Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum BernRecruiting
Bern, Switzerland
Changhua Christian HospitalNot Yet Recruiting
Changhua, Changhua County, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Zhongzheng District, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation TrustRecruiting
Cambridge, Cambridgeshire, United Kingdom
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS TrustRecruiting
London, E1 2at, United Kingdom
South Eastern Health and Social Care Trust - The Ulster HospitalRecruiting
Belfast, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation TrustRecruiting
London, United Kingdom
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 · TrialPath