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
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
3 other identifiers
interventional
268
25 countries
194
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2024
Typical duration for phase_2
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 23, 2027
April 13, 2026
April 1, 2026
2.5 years
January 23, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Endoscopic response is defined by decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline). SES-CD evaluates 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).
Week 12
Secondary Outcomes (9)
Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 12
Week 12
Percentage of Participants With a Clinical Response Based on the CDAI at Week 12
Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12.
Week 12
Percentage of Participants Achieving Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) at Week 12
Week 12
Percentage of Participants With a Clinical Response in PRO2 at Week 12
Week 12
- +4 more secondary outcomes
Study Arms (4)
TAK-279 Dose 1
EXPERIMENTALParticipants will be randomized to receive TAK-279 Dose 1 capsules with TAK-279 placebo-matching capsule orally.
TAK-279 Dose 2
EXPERIMENTALParticipants will be randomized to receive TAK-279 Dose 2 capsules with TAK-279 placebo-matching capsule orally.
TAK-279 Dose 3
EXPERIMENTALParticipants will be randomized to receive TAK-279 Dose 3 capsules orally.
Placebo
EXPERIMENTALParticipants will be randomized to receive TAK-279 placebo-matching capsules orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.
- 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.
You may not qualify if:
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- Have complications of CD that might require surgery during the study.
- Participants with a current ostomy.
- Participants who have failed 3 or more classes of advanced therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (194)
GastroIntestinal BioSciences
Los Angeles, California, 90067, United States
United Medical Doctors
Murrieta, California, 92563, United States
UCI Health
Orange, California, 92868, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, 33762, United States
Auzmer Research
Lakeland, Florida, 33813, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
GI PROS, Inc.
Naples, Florida, 34102, United States
AdventHealth (Florida Hospital) Medical Group
Orlando, Florida, 32804, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
Emory University Hospital, The Emory Clinic
Atlanta, Georgia, 30322, United States
Atlanta Center For Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061, United States
BVL Clinical Research
Liberty, Missouri, 64068, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
University Gastroenterology Providence
Providence, Rhode Island, 02904, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29615, United States
Novel Research, LLC
Bellaire, Texas, 77401, United States
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance
Fort Worth, Texas, 76104, United States
One of a Kind Clinical research Center TX LLC
Kingwood, Texas, 77339, United States
TDDC dba Alliance Research
Mansfield, Texas, 76063, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Concord Repatriation General Hospital
Sydney, New South Wales, 2139, Australia
Mater Cancer Care Centre-Mater Health Services
South Brisbane, Queensland, 4101, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Western Health/Footscray Hospital
Melbourne, Victoria, 3011, Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Northern Hospital Epping
Epping, 3076, Australia
Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre
Nedlands, 6009, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, 1070, Belgium
CHU Saint-Pierre - Porte de Hal
Brussels, 1000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
L2 IP - Instituto de Pesquisas Clinicas LTDA
Brasília, Federal District, 70200-730, Brazil
Galileo Medical Research
Juiz de Fora, Minas Gerais, 36033-318, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18618-970, Brazil
UniversidadeEstadualde Campinas - UNICAMP
Campinas, São Paulo, 13083-887, Brazil
Centro de Estudos Clnicos do Interior Paulista (CECIP)
Jaú, São Paulo, 17201-130, Brazil
Ribeiralo Preto Medical School, University of Salo Paulo
Ribeirão Preto, São Paulo, 14048-900, Brazil
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, 11075-900, Brazil
Solare Trials
São Paulo, 01307-002, Brazil
UMBAL Kaspela
Plovdiv, 4001, Bulgaria
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
Sliven, 8800, Bulgaria
Acibadem City clinic Tokuda hospital
Sofia, 1407, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, 1431, Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
Sofia, 1527, Bulgaria
Acibadem City Clinic Mladost Hospital
Sofia, 1784, Bulgaria
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4, Canada
Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, Canada
University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute
Toronto, Ontario, M5G 1X5, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9, Canada
The Research Institute of the McGill University Health Center
Montreal, Quebec, H3G 1A4, Canada
Chongqing General Hospital
Chongqing, Chongqing Sheng, 400013, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000, China
Sun Yat-sen University (SYSU) - The First Affiliated Hospital
Guangzhou, Guangdong, 510080, China
Huizhou First Hospital
Huizhou, Guangdong, 516001, China
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
Shenyang, Liaoning, 110022, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
Guangzhou, 510655, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, 310016, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, 201318, China
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, 310006, China
NH Hospital
Hořovice, Central Bohemia, 268 31, Czechia
SurGal Clinic SRO
Brno, 602 00, Czechia
Vojenska Nemocnice Brno
Brno, 636 00, Czechia
University Hospital Brno
Brno, 639 00, Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 370 01, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
EndoArt
Ostrava, 71000, Czechia
Fakultni Nemocnice Ostrava (FNO)
Ostrava-Poruba, 708 52, Czechia
Gastromedic s.r.o
Pardubice, 530 03, Czechia
Endohope Clinic
Prague, 10100, Czechia
Axon Clinical s.r.o.
Prague, 15000, Czechia
Masaryk Hospital
Ústí nad Labem, 40113, Czechia
Odense Universitetshospital (OUH) (Odense University Hospital)
Odense, Region Syddanmark, 5000, Denmark
Aalborg Hospital
Aalborg, 9100, Denmark
Sydvestjysk Region/Esbjerg Hospital
Esbjerg, 6700, Denmark
Hillerod Hospital, Hilleroed Sygehus
Hillerød, 3400, Denmark
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, 2650, Denmark
Region Sjaelland Sygehus Nord, Koge Sygehus
Køge, 4600, Denmark
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
Chambray-lès-Tours, 37170, France
CHU De Clermont Ferrand - Hopital Estaing
Clermont-Ferrand, 63000, France
Hopital l'Archet 2
Nice, 06202, France
Hopital Nord Chu Saint-Etienne
Saint-Etienne, 42055, France
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinik Frankfurt
Frankfurt, 60590, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105, Germany
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67065, Germany
Universitaetsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
University Hospital Of Ulm, Universitatsklinikum Ulm
Ulm, 89081, Germany
University General Hospital of Patras
Pátrai, Achaia, 26504, Greece
Evangelismos Hospital
Athens, Attica, 106 76, Greece
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attica, 11528, Greece
University Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Sotiria General Hospital of Athens
Athens, 11527, Greece
G.N.A. Gennimatas
Athens, 15669, Greece
Clinexpert
Budapest, 1033, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Pannonia Maganorvosi Centrum Kft.
Budapest, 1136, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
Soroka Mc
Beersheba, 84101, Israel
Digestive Disease Institute, Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
Ramat Gan, 5265601, Israel
The Chaim Sheba Medical Centre
Tel Aviv, 5265601, Israel
IRCCS - AOU di Bologna - SantOrsola Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena - Clinica Mangiagalli
Milan, 20122, Italy
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 00168, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152, Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089, Italy
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 5731191, Japan
Osaka Medical College Hospital
Takatsuki-shi, Osaka, 569-8686, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
The Jikei University Hospital
Minato, Tokyo, 105-8471, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Tsujinaka Hospital Kashiwanoha
Chiba, 277-0871, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Institute of Science Tokyo Hospital
Tokyo, 113-8519, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Zuyderland Medisch Centrum - Sittard-Geleen
Geleen, Limburg, 6162 BG, Netherlands
Amsterdam University Medical Center (Amsterdam UMC), Vrije University Medical Center (VUMC)
Amsterdam, 1081, Netherlands
St. Elisabeth Ziekenhuis
Tilburg, 5022 GC, Netherlands
Akershus University Hospital
Lorenskog, Akershus, 1478, Norway
Oslo Univeristy Hospital Ulleval Hospital
Oslo, 0450, Norway
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
Torun, Kujawsko-pomo, 87-100, Poland
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
PlanetMed Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Panstwowy Instytut Medyczny MSWiA
Warsaw, Masovian Voivodeship, 02-507, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Manermed Sp. z o.o - CM Medis
Bydgoszcz, 85229, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Centrum Medyczne Med-Gastr
Lodz, 91-034, Poland
Medrise sp. z o.o
Lublin, 20-582, Poland
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
Rzeszów, 35-326, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35302, Poland
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, 43-100, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Centrum Badan Klinicznych
Wroclaw, 51-162, Poland
ETG Zamosc
Zamość, 22400, Poland
AmiCare Sp. z o.o. Sp. k.
Lodz, Łódź Voivodeship, 91-495, Poland
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
Timișoara, Jud Timis, 300002, Romania
Clinical Hospital Colentina-Spitalul Clinic Colentina
Bucharest, 0 50159, Romania
Clinica Medicum
Bucharest, 012015, Romania
Spital Clinic Dr I Cantacuzino
Bucharest, 020475, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Euroclinic
Bucharest, 14461, Romania
Fakultna nemocnica F. D. Roosevelta
Banská Bystrica, 97401, Slovakia
Cliniq s. r. o.
Bratislava, 811 09, Slovakia
Endomed
Košice, 4013, Slovakia
Fakultna Nemocnica s poliklinikou Nove Zamky
Nové Zámky, 94034, Slovakia
Accout Center, s.r.o.- Gastroenterologicka ambulancia
Šahy, 936 01, Slovakia
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center (AMC)
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
University Hospital Basel
Basel, 4031, Switzerland
Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern
Bern, 3012, Switzerland
Changhua Christian Hospital
Changhua, Changhua County, 50006, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng District, 100, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust
London, E1 2at, E1 2AT, United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, BT16 1RH, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2024
First Posted
January 31, 2024
Study Start
March 5, 2024
Primary Completion (Estimated)
September 18, 2026
Study Completion (Estimated)
July 23, 2027
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.