NCT06233461RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 268 (estimated)
- First submitted
- 23 Jan 2024
- Start date
- 5 Mar 2024
- Primary completion date
- 17 Feb 2027
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT06233461
- EU CT number
- 2023-506704-14-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 268
- From 5 Mar 2024 to the primary completion date, 17 Feb 2027
- 206 sites in 25 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have complications of CD that might require surgery during the study.
- Participants who have failed 3 or more classes of advanced therapies.
Other illness
- Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
Other
- Participants with a current ostomy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (206)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Bedford Park | Australia | Recruiting |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| Northern Hospital Epping Coordinator of this site? Confirm its status | Epping | Australia | Recruiting |
| Western Health/Footscray Hospital Coordinator of this site? Confirm its status | Footscray | Australia | Recruiting |
| Harry Perkins Medical Research Institute Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Sir Charles Gairdner Hospital (SCGH) - Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Mater Cancer Care Centre-Mater Health Services Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| CHU Saint-Pierre Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Coordinator of this site? Confirm its status | Sliven | Bulgaria | Recruiting |
| Acibadem City clinic University Hospital EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University Hospital Queen Govanna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Universidade Estadual Paulista Julio De Mesquita Filho (Unesp) - Faculdade de Medicina de Botucatu Coordinator of this site? Confirm its status | Botucatu | Brazil | Not yet recruiting |
| L2 IP Instituto de Pesquisas Clinicas Ltda Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| UniversidadeEstadualde Campinas - UNICAMP Coordinator of this site? Confirm its status | Campinas | Brazil | Recruiting |
| Centro de Estudos Clnicos do Interior Paulista (CECIP) Coordinator of this site? Confirm its status | Jaú | Brazil | Not yet recruiting |
| Galileo Medical Research Coordinator of this site? Confirm its status | Juiz de Fora | Brazil | Recruiting |
| Hospital de Clínicas de Porto Alegre - HCPA Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| Ribeiralo Preto Medical School, University of Salo Paulo Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Recruiting |
| Irmandade da Santa Casa da Misericórdia de Santos Coordinator of this site? Confirm its status | Santos | Brazil | Recruiting |
| Solare Trials Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Heritage Medical Research Clinic - University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Nova Scotia Health Authority - Queen Elizabeth II Heath Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| London Digestive Disease Institute Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| London Health Sciences Centre, University Hospital Coordinator of this site? Confirm its status | London | Canada | Active, not recruiting |
| The Research Institute of the McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Fraser Clinical Trials Coordinator of this site? Confirm its status | New Westminster | Canada | Recruiting |
| University of Toronto - Mount Sinai Hospital - The Lunenfeld-Tanenbaum Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| The Second People's Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
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| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
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| Wuhan University - Renmin Hospital (Hubei General Hospital) Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
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| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
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| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Gastromedic s.r.o Coordinator of this site? Confirm its status | Pardubice | Czechia | Recruiting |
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| Endohope klinika s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Recruiting |
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| Krajská zdravotní a.s. - Masarykova nemocnice Ústí nad Labem, o.z. Coordinator of this site? Confirm its status | Ústí nad Labem | Czechia | Recruiting |
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| St. Marien und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Recruiting |
| Universitaetsklinikum Mannheim GmbH Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
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| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Recruiting |
| Region Nordjylland Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Hillerod Hospital Coordinator of this site? Confirm its status | Hilleroed | Denmark | Recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Koege | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Recruiting |
| Centre Medico Chirurgical Ambroise Pare Hartmann Coordinator of this site? Confirm its status | Neuilly-Sur-Seine | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| South Eastern Health and Social Care Trust - The Ulster Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Recruiting |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Recruiting |
| Pannonia Maganorvosi Centrum Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Recruiting |
| EURO-ENDO-MED Kft. Coordinator of this site? Confirm its status | Mohács | Hungary | Recruiting |
| Assuta Ashdod Medical Center Coordinator of this site? Confirm its status | Ashdod | Israel | Recruiting |
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| Digestive Disease Institute, Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
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| The Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Tsujinaka Hospital Kashiwanoha Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Hamamatsu University Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Recruiting |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Recruiting |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Minato | Japan | Recruiting |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Mitaka | Japan | Recruiting |
| Iwate Medical University Uchimaru Medical Center Coordinator of this site? Confirm its status | Morioka | Japan | Recruiting |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Recruiting |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki-shi | Japan | Recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Recruiting |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center (AMC) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
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| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Geleen | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
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| Sykehuset Innlandet HF Coordinator of this site? Confirm its status | Gjoevik | Norway | Recruiting |
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| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
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