NCT06254950Active, not recruitingPhase 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 Ulcerative Colitis
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 213 (actual)
- First submitted
- 2 Feb 2024
- Start date
- 29 Mar 2024
- Primary completion date
- 14 Jul 2026
- Lead sponsor
- Takeda
- Diseases
- Ulcerative colitis
- NCT number
- NCT06254950
- EU CT number
- 2023-506769-67-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 213
- From 29 Mar 2024 to the primary completion date, 14 Jul 2026
- 141 sites in 22 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
- Participants who have failed 3 or more classes of advanced therapies.
Other illness
- Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
- Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
Other
- Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
Who the study is looking for
- Male or female aged 18-75 years old with diagnosis of UC 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 UC assessed by mMS and ES.
- Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
- Participants must meet the contraception recommendations.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (141)
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 | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Western Health - Footscray Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Harry Perkins Medical Research Institute Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Sir Charles Gairdner Hospital Lung Institute Of Western Australia Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Mater Cancer Care Centre-Mater Health Services Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville | Australia | Unknown status |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Kaspela EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Acibadem City clinic University Hospital EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Medical center Asclepion humane medicine researches EOOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Active, not recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Acibadem City Clinic Tokuda University Hospital EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| University Hospital Queen Govanna Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Heritage Medical Research Clinic - University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| London Health Sciences Centre, University Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Research Institute of the McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Fraser Clinical Trials Coordinator of this site? Confirm its status | New Westminster | Canada | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second People's Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing General Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Wuhan University - Renmin Hospital (Hubei General Hospital) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai Pudong New District Zhoupu Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| SurGal Clinic s.r.o. Coordinator of this site? Confirm its status | Brno-Sever | Czechia | Active, not recruiting |
| Vojenska Nemocnice Brno Coordinator of this site? Confirm its status | Brno-Zidenice | Czechia | Active, not recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Active, not recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Active, not recruiting |
| Gastromedic s.r.o Coordinator of this site? Confirm its status | Pardubice | Czechia | Active, not recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Endohope klinika s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Active, not recruiting |
| EndoArt s.r.o. Coordinator of this site? Confirm its status | Slezska Ostrava | Czechia | Active, not recruiting |
| Krajska zdravotni a.s. Coordinator of this site? Confirm its status | Usti Nad Labem | Czechia | Active, not recruiting |
| Agaplesion Frankfurter Diakonie Kliniken gGmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Active, not recruiting |
| Praxis für Gastroenterolgie Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| St. Marien und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Gistrup | Denmark | Active, not recruiting |
| Hillerod Hospital Coordinator of this site? Confirm its status | Hilleroed | Denmark | Active, not recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Active, not recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Koege | Denmark | Active, not recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Active, not recruiting |
| South Eastern Health and Social Care Trust - The Ulster Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Unknown status |
| Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Clinical Research Centre - Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Active, not recruiting |
| Pannonia Maganorvosi Centrum Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Active, not recruiting |
| EURO-ENDO-MED Kft. Coordinator of this site? Confirm its status | Mohács | Hungary | Active, not recruiting |
| Javorszky Oedoen Korhaz Coordinator of this site? Confirm its status | Vac | Hungary | Active, not recruiting |
| Assuta Ashdod University Hospital Coordinator of this site? Confirm its status | Ashdod | Israel | Unknown status |
| Soroka Mc Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Fukuoka University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| The Jikei University Hospital Coordinator of this site? Confirm its status | Minato | Japan | Unknown status |
| Kitasato University Kitasato Institute Hospital Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Mitaka | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Toho University Sakura Medical Center Coordinator of this site? Confirm its status | Sakura | Japan | Unknown status |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center (AMC) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Active, not recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Manermed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Active, not recruiting |
| 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 | Active, not recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Active, not recruiting |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Active, not recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. Coordinator of this site? Confirm its status | Tychy | Poland | Active, not recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| PlanetMed Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Melita Medical Sp. z o.o. Coordinator of this site? Confirm its status | Wrocław | Poland | Active, not recruiting |
| Monza-Ares S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Delta Health Care S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Baneasa Tumor Center Hospital Coordinator of this site? Confirm its status | Bucuresti | Romania | Active, not recruiting |
| Cabinet Particular Policlinic Algomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Active, not recruiting |
| F D Roosevelt University General Hospital Of Banska Bystrica Coordinator of this site? Confirm its status | Banska Bystrica | Slovakia | Active, not recruiting |
| Cliniq s.r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Active, not recruiting |
| ENDOMED, s.r.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Active, not recruiting |
| Fakultna nemocnica s poliklinikou Nove Zamky Coordinator of this site? Confirm its status | Nové Zámky | Slovakia | Active, not recruiting |
| Accout Center s.r.o. Coordinator of this site? Confirm its status | Šahy | Slovakia | Active, not recruiting |
| Changhua Christian Hospital (CCH) Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital NTUH Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Emory University Hospital, The Emory Clinic Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Novel Research LLC Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| West Central Gastroenterology, LLP, d/b/a/ Gastro Florida Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Atlanta Center For Gastroenterology, P.C. Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Woodholme Gastroenterology Associates Coordinator of this site? Confirm its status | Glen Burnie | United States | Unknown status |
| Gastroenterology Associates, PA Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Auzmer Research Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Las Vegas Medical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| GastroIntestinal BioSciences Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| United Medical Doctors Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
| GI PROS, Inc. Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| University Gastroenterology Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| USF Health Morsani Center for Advanced Healthcare Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Tyler Research Institute, LLC Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.