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
3 other identifiers
interventional
207
22 countries
141
Brief Summary
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.
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
141 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedStudy Start
First participant enrolled
March 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2027
May 6, 2026
May 1, 2026
2.5 years
February 2, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)
The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of ≤2 with SF subscore ≤ 1, RB subscore = 0, and ES ≤ 1 (score of 1 modified to exclude friability).
Week 12
Secondary Outcomes (9)
Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)
Baseline, Week 12
Percentage of Participants Achieving Symptomatic Remission at Week 12
Week 12
Percentage of Participants Achieving Endoscopic Improvement at Week 12
Week 12
Percentage of Participants Achieving Endoscopic Remission at Week 12
Week 12
Percentage of Participants With no Bowel Urgency at Week 12
Week 12
- +4 more secondary outcomes
Study Arms (3)
TAK-279 Dose 1
EXPERIMENTALTAK-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 Dose 2
EXPERIMENTALTAK-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.
Placebo
PLACEBO COMPARATORTAK-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
- Participants who have failed 3 or more classes of advanced therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (141)
GastroIntestinal BioSciences
Los Angeles, California, 90067, United States
United Medical Doctors
Murrieta, California, 92563, United States
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
Clearwater, Florida, 33762, United States
Auzmer Research
Lakeland, Florida, 33813, United States
GI PROS, Inc.
Naples, Florida, 34102, 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
University Of Louisville
Louisville, Kentucky, 40202, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
University Gastroenterology
Providence, Rhode Island, 02904, United States
Gastroenterology Associates, PA
Greenville, South Carolina, 29607, United States
Novel Research, LLC
Bellaire, Texas, 77401, 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
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Western Health/Footscray Hospital
Melbourne, Victoria, 3011, Australia
Sir Charles Gairdner Hospital Lung Institute Of Western Australia
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Harry Perkins Medical Research Institute Fiona Stanley Hospital
Murdoch, 6150, Australia
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussels, Anderlecht / Region Capitale de Bruxelles/ Brussel, 1070, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
UMBAL Kaspela
Plovdiv, 4001, Bulgaria
Pecs University Clinical Center Mohacs Hospital
Sofia, 1000, 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
University Hospital City Clinic Cancer Center
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
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, 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, 401147, China
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
Guangzhou, Guangdong, 3011, China
Wuhan University - Renmin Hospital (Hubei General Hospital)
Chongqing, Hubei, 430060, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Second People's Hospital of Changzhou
Changzhou, Jiangsu, 200001, China
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
Shenyang, Liaoning, 110022, China
Renji hospital shanghai jiao tong university school of medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, 310016, China
Shanghai Pudong New District Zhoupu Hospital
Shanghai, 201318, 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
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 50012, Czechia
EndoArt
Ostrava, 71000, Czechia
Fakultni Nemocnice Ostrava (FNO)
Ostrava-Poruba, 708 00, 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
CHU De Clermont Ferrand - Hopital Estaing
Clermont-Ferrand, 63000, France
Hopital l'Archet 2
Nice, 6202, France
Hopital Nord Chu Saint-Etienne
Saint-Etienne, 42055, France
Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois
Vandœuvre-lès-Nancy, 54500, France
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
Hamburg, 20251, Germany
Praxis fur Gastroenterologie
Heidelberg, 69115, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105, Germany
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67065, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
University Hospital Of Ulm, Universitatsklinikum Ulm
Ulm, 89081, Germany
University General Hospital of Patras
Pátrai, Achaia, 26504, Greece
Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
Athens, Attica, 106 76, 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
Javorszky Odon Korhaz
Vác, 2600, Hungary
Assuta Ashdod University Hospital
Ashdod, 7747629, Israel
Soroka Mc
Beersheba, 84101, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
Ramat Gan, 5265601, Israel
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna, 40138, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
Milan, 20132, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, 152, Italy
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
Rozzano, 20089, Italy
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 5731191, Japan
The jikei University Hospital
Minato, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Saga University Hospital
Saga, 849-0937, Japan
Akershus University Hospital
Lorenskog, Akershus, 1478, Norway
Oslo Univeristy Hospital Ulleval Hospital
Oslo, 450, Norway
Centrum Medyczne Melita Medical
Wroclaw, Dolnolskie, 50-449, Poland
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
Torun, Kujawsko-pomo, 87-100, Poland
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, 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
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Medrise sp. z o.o
Lublin, 20-582, Poland
Centrum Medyczne MedykSp. 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
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
Timișoara, Jud Timis, 300002, Romania
Monza-Ares Srl
Bucharest, Sector 2, 021967, Romania
Clinical Hospital Colentina-Spitalul Clinic Colentina
Bucharest, 0 50159, Romania
Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti
Bucharest, 13823, Romania
Delta Health Care
Bucharest, 14142, Romania
Spital Clinic Dr I Cantacuzino
Bucharest, 20475, 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
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Asan Medical Center (AMC)
Seoul, 5505, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Changhua Christian Hospital (CCH)
Changhua, Changhua County, 50006, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Zhongzheng District, 100, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Clinical Research Centre - 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
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2024
First Posted
February 12, 2024
Study Start
March 29, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
August 4, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05
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.