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
NCT ID: NCT06254950
Last Updated: 2025-12-18
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
207 participants
INTERVENTIONAL
2024-03-29
2027-08-04
Brief Summary
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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.
Detailed Description
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An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -
1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. Placebo
The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TAK-279 Dose 1
TAK-279, capsules, orally at Dose 1 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
TAK-279
TAK-279 capsules.
TAK-279 Dose 2
TAK-279, capsules, orally at Dose 2 up to Week 12 followed by either Dose 1 or Dose 2 up to week 52 based on the response.
TAK-279
TAK-279 capsules.
Placebo
TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally either Dose 1 or Dose 2 up to Week 52 based on the response.
TAK-279
TAK-279 capsules.
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 UC assessed by mMS and ES.
3. 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.
4. Participants must meet the contraception recommendations.
Exclusion Criteria
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
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
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, United States
Auzmer Research
Lakeland, 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
University Of Louisville
Louisville, Kentucky, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastroenterology Associates, PA
Greenville, South Carolina, United States
Novel Research, LLC
Bellaire, 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
The Alfred Hospital
Melbourne, Victoria, Australia
Western Health/Footscray Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital Lung Institute Of Western Australia
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, , Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
UMBAL Kaspela
Plovdiv, , Bulgaria
Pecs University Clinical Center Mohacs Hospital
Sofia, , 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
University Hospital City Clinic Cancer Center
Sofia, , Bulgaria
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
Fraser Clinical Trials
New Westminster, British Columbia, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
London, 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
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
Guangzhou, Guangdong, China
Wuhan University - Renmin Hospital (Hubei General Hospital)
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, 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
West China Hospital of Sichuan University
Chengdu, Sichuan, 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
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
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
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
Hamburg, , Germany
Praxis fur Gastroenterologie
Heidelberg, , Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, , Germany
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
University Hospital Of Ulm, Universitatsklinikum Ulm
Ulm, , Germany
University General Hospital of Patras
Pátrai, Achaia, Greece
Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
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
Javorszky Odon Korhaz
Vác, , Hungary
Assuta Ashdod University Hospital
Ashdod, , Israel
Soroka Mc
Beersheba, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
Ramat Gan, , Israel
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, , Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, , Italy
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
The jikei University Hospital
Minato, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Fukuoka University Hospital
Fukuoka, , Japan
Saga University Hospital
Saga, , Japan
Akershus University Hospital
Lorenskog, Akershus, Norway
Oslo Univeristy Hospital Ulleval Hospital
Oslo, , Norway
Centrum Medyczne Melita Medical
Wroclaw, Dolnolskie, Poland
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
Torun, Kujawsko-pomo, Poland
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian 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
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Medrise sp. z o.o
Lublin, , Poland
Centrum Medyczne MedykSp. 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
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
Timișoara, Jud Timis, Romania
Clinical Hospital Colentina-Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti
Bucharest, , Romania
Delta Health Care
Bucharest, , Romania
Spital Clinic Dr I Cantacuzino
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
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center (AMC)
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Changhua Christian Hospital (CCH)
Changhua, Changhua County, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng District, Taiwan
China Medical University Hospital
Taichung, , Taiwan
Clinical Research Centre - Barts Health NHS Trust
London, E1 2at, United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
Belfast, , United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, , 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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Related Links
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To obtain more information about this study, click this link
Other Identifiers
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2023-506769-67-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2031240228
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-279-UC-2001
Identifier Type: -
Identifier Source: org_study_id