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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 Ulcerative Colitis
NCT06254950 · Takeda
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.
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.
Eligibility criteria
Inclusion Criteria:
1. 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.
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:
1. 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).
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.
Study design
Enrollment target: 207 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-03-29
Estimated completion: 2027-08-04
Last updated: 2026-04-13
Interventions
Drug: TAK-279Drug: Placebo
Primary outcomes
- • Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS) (Week 12)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (141)
GastroIntestinal BioSciencesRecruiting
Los Angeles, California, United States
United Medical DoctorsRecruiting
Murrieta, California, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro FloridaRecruiting
Clearwater, Florida, United States
Auzmer ResearchRecruiting
Lakeland, Florida, United States
GI PROS, Inc.Recruiting
Naples, 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
University Of LouisvilleRecruiting
Louisville, Kentucky, United States
Woodholme Gastroenterology AssociatesRecruiting
Glen Burnie, Maryland, United States
Las Vegas Medical ResearchRecruiting
Las Vegas, Nevada, United States
University GastroenterologyRecruiting
Providence, Rhode Island, United States
Gastroenterology Associates, PARecruiting
Greenville, South Carolina, United States
Novel Research, LLCRecruiting
Bellaire, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
University of Washington Medical CenterNot Yet Recruiting
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
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Western Health/Footscray HospitalRecruiting
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital Lung Institute Of Western AustraliaRecruiting
Nedlands, Western Australia, Australia
Royal Perth HospitalRecruiting
Perth, Western Australia, Australia
Harry Perkins Medical Research Institute Fiona Stanley HospitalRecruiting
Murdoch, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis BursselRecruiting
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
UMBAL KaspelaRecruiting
Plovdiv, Bulgaria
Pecs University Clinical Center Mohacs HospitalRecruiting
Sofia, Bulgaria
Acibadem City clinic Tokuda hospitalRecruiting
Sofia, Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOODRecruiting
Sofia, Bulgaria
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)Not Yet Recruiting
Sofia, Bulgaria
University Hospital City Clinic Cancer CenterRecruiting
Sofia, Bulgaria
Heritage Medical Research Clinic - University Of CalgaryRecruiting
Calgary, Alberta, Canada
Fraser Clinical TrialsRecruiting
New Westminster, British Columbia, Canada
London Health Sciences Centre - University HospitalRecruiting
London, Ontario, Canada
London Health Sciences Centre - Victoria HospitalRecruiting
London, 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
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)Recruiting
Guangzhou, Guangdong, China
Wuhan University - Renmin Hospital (Hubei General Hospital)Recruiting
Chongqing, Hubei, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
The Second People's Hospital of ChangzhouRecruiting
Changzhou, Jiangsu, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang CampusRecruiting
Shenyang, Liaoning, China
Renji hospital shanghai jiao tong university school of medicineRecruiting
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)Recruiting
Hangzhou, China
Shanghai Pudong New District Zhoupu HospitalRecruiting
Shanghai, China
NH HospitalNot Yet Recruiting
Hořovice, Central Bohemia, Czechia
SurGal Clinic SRORecruiting
Brno, Czechia
Vojenska Nemocnice BrnoRecruiting
Brno, Czechia
University Hospital BrnoNot Yet Recruiting
Brno, 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 HospitalNot Yet Recruiting
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
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
Agaplesion Markus KrankenhausRecruiting
Frankfurt am Main, Germany
Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)Not Yet Recruiting
Hamburg, Germany
Praxis fur GastroenterologieRecruiting
Heidelberg, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus KielRecruiting
Kiel, Germany
St. Marien- und St. AnnastiftskrankenhausRecruiting
Ludwigshafen, Germany
Universitaetsklinikum TuebingenRecruiting
Tübingen, Germany
University Hospital Of Ulm, Universitatsklinikum UlmRecruiting
Ulm, Germany
University General Hospital of PatrasRecruiting
Pátrai, Achaia, Greece
Evaggelismos Hospital (Evangelismos Hospital)-University of AthensRecruiting
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
Javorszky Odon KorhazRecruiting
Vác, Hungary
Assuta Ashdod University HospitalRecruiting
Ashdod, Israel
Soroka McRecruiting
Beersheba, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's HospitalRecruiting
Ramat Gan, Israel
IRCCS A.O.U. Policlinico S. Orsola - MalpighiRecruiting
Bologna, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele HospitalRecruiting
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia CervelloRecruiting
Palermo, Italy
Azienda Ospedaliera San Camillo ForlaniniRecruiting
Rome, Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spaRecruiting
Rozzano, Italy
Toho University Sakura Medical CenterRecruiting
Sakura, Chiba, Japan
Sapporo Medical University HospitalRecruiting
Sapporo, Hokkaido, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Osaka, Japan
The jikei University HospitalRecruiting
Minato, Tokyo, Japan
Kitasato University Kitasato Institute HospitalRecruiting
Minato-ku, Tokyo, Japan
Kyorin University HospitalRecruiting
Mitaka, Tokyo, Japan
Fukuoka University HospitalRecruiting
Fukuoka, Japan
Saga University HospitalRecruiting
Saga, Japan
Akershus University HospitalRecruiting
Lorenskog, Akershus, Norway
Oslo Univeristy Hospital Ulleval HospitalRecruiting
Oslo, Norway
Centrum Medyczne Melita MedicalRecruiting
Wroclaw, Dolnolskie, Poland
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety LekarskieRecruiting
Torun, Kujawsko-pomo, Poland
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w BydgoszczyRecruiting
Bydgoszcz, Kuyavian-Pomeranian 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
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w LodziRecruiting
Lodz, Poland
Medrise sp. z o.oRecruiting
Lublin, Poland
Centrum Medyczne MedykSp. 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
Policlinica Algomed: Centrul De Gastroenterologie Dr. GoldisRecruiting
Timișoara, Jud Timis, Romania
Monza-Ares SrlRecruiting
Bucharest, Sector 2, Romania
Clinical Hospital Colentina-Spitalul Clinic ColentinaRecruiting
Bucharest, Romania
Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu SisestiRecruiting
Bucharest, Romania
Delta Health CareRecruiting
Bucharest, Romania
Spital Clinic Dr I CantacuzinoRecruiting
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
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical Center (AMC)Recruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Changhua Christian Hospital (CCH)Not Yet Recruiting
Changhua, Changhua County, Taiwan
National Taiwan University Hospital (NTUH)Not Yet Recruiting
Taipei, Zhongzheng District, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
Clinical Research Centre - Barts Health NHS TrustRecruiting
London, E1 2at, United Kingdom
South Eastern Health and Social Care Trust - The Ulster HospitalRecruiting
Belfast, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation TrustRecruiting
Cambridge, United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation TrustRecruiting
London, United Kingdom