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
Status: Recruiting
Location: See all (165) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
GastroIntestinal BioSciences
RECRUITING
Los Angeles
United Medical Doctors
RECRUITING
Murrieta
UCI Health
NOT_YET_RECRUITING
Orange
Florida
West Central Gastroenterology, LLP, d/b/a/ Gastro Florida
RECRUITING
Clearwater
Auzmer Research
RECRUITING
Lakeland
GI PROS, Inc.
RECRUITING
Naples
USF Health Morsani Center for Advanced Healthcare
RECRUITING
Tampa
Georgia
Emory University Hospital, The Emory Clinic
RECRUITING
Atlanta
Atlanta Center For Gastroenterology, P.C.
RECRUITING
Decatur
Iowa
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
NOT_YET_RECRUITING
Iowa City
Kentucky
University Of Louisville
RECRUITING
Louisville
Maryland
Woodholme Gastroenterology Associates
RECRUITING
Glen Burnie
Missouri
BVL Clinical Research
NOT_YET_RECRUITING
Liberty
Nevada
Las Vegas Medical Research
RECRUITING
Las Vegas
New York
Rochester Clinical Research
NOT_YET_RECRUITING
New York
DiGiovanna Institute for Medical Education and Research
NOT_YET_RECRUITING
North Massapequa
Oklahoma
Hightower Clinical - SSM Health
NOT_YET_RECRUITING
Oklahoma City
Rhode Island
University Gastroenterology
RECRUITING
Providence
South Carolina
Gastroenterology Associates, PA
RECRUITING
Greenville
Texas
Novel Research, LLC
RECRUITING
Bellaire
Victorium Clinical Research
WITHDRAWN
Houston
Tyler Research Institute, LLC
RECRUITING
Tyler
Washington
University of Washington Medical Center
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Flinders Medical Centre
NOT_YET_RECRUITING
Bedford Park
Northern Hospital Epping
NOT_YET_RECRUITING
Epping
Austin Hospital
NOT_YET_RECRUITING
Heidelberg
Nepean Clinical School
NOT_YET_RECRUITING
Kingswood
The Alfred Hospital
NOT_YET_RECRUITING
Melbourne
Western Health/Footscray Hospital
NOT_YET_RECRUITING
Melbourne
Harry Perkins Medical Research Institute Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
Sir Charles Gairdner Hospital Lung Institute Of Western Australia
NOT_YET_RECRUITING
Nedlands
Royal Perth Hospital
NOT_YET_RECRUITING
Perth
Mater Cancer Care Centre-Mater Health Services
NOT_YET_RECRUITING
South Brisbane
Concord Repatriation General Hospital
NOT_YET_RECRUITING
Sydney
The Queen Elizabeth Hospital
NOT_YET_RECRUITING
Woodville
Belgium
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
RECRUITING
Brussels
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Bulgaria
UMBAL Kaspela
RECRUITING
Plovdiv
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
NOT_YET_RECRUITING
Sliven
Acibadem City clinic Tokuda hospital
NOT_YET_RECRUITING
Sofia
Diagnostic-Consultative Center Aleksandrovska EOOD
NOT_YET_RECRUITING
Sofia
Pecs University Clinical Center Mohacs Hospital
NOT_YET_RECRUITING
Sofia
University Hospital City Clinic Cancer Center
NOT_YET_RECRUITING
Sofia
University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)
NOT_YET_RECRUITING
Sofia
Canada
Heritage Medical Research Clinic - University Of Calgary
RECRUITING
Calgary
London Health Sciences Centre - University Hospital
RECRUITING
London
London Health Sciences Centre - Victoria Hospital
RECRUITING
London
Centre Hospitalier de l'Universite de Montreal
NOT_YET_RECRUITING
Montreal
The Research Institute of the McGill University Health Center
NOT_YET_RECRUITING
Montreal
Fraser Clinical Trials
RECRUITING
New Westminster
China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
The Second People's Hospital of Changzhou
NOT_YET_RECRUITING
Changzhou
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing General Hospital
NOT_YET_RECRUITING
Chongqing
Sun Yat-sen University - The Sixth Affiliated Hospital (Guangdong Gastrointestinal Hospital)
NOT_YET_RECRUITING
Guangzhou
Zhejiang University School of Medicine - Sir Run Run Shaw Hospital (SRRSH)
RECRUITING
Hangzhou
Renji hospital shanghai jiao tong university school of medicine
NOT_YET_RECRUITING
Shanghai
Shanghai Pudong New District Zhoupu Hospital
NOT_YET_RECRUITING
Shanghai
China Medical University (CMU) - Shengjing Hospital (The Second Affiliated Hospital) - Huaxiang Campus
NOT_YET_RECRUITING
Shenyang
Wuhan University - Renmin Hospital (Hubei General Hospital)
NOT_YET_RECRUITING
Wuhan
Denmark
Aalborg Hospital
RECRUITING
Aalborg
Sydvestjysk Region/Esbjerg Hospital
RECRUITING
Esbjerg
Hillerod Hospital, Hilleroed Sygehus
RECRUITING
Hillerød
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
RECRUITING
Hvidovre
Region Sjaelland Sygehus Nord, Koge Sygehus
RECRUITING
Køge
Odense Universitetshospital (OUH) (Odense University Hospital)
RECRUITING
Odense
France
Centre Hospital Regional Et Universitaire De Tours (Chru Tours) - Houpital Trousseau
NOT_YET_RECRUITING
Chambray-lès-tours
CHU De Clermont Ferrand - Hopital Estaing
RECRUITING
Clermont-ferrand
Hopital l'Archet 2
RECRUITING
Nice
Hopital Nord Chu Saint-Etienne
RECRUITING
Saint-etienne
Centre Hospitalier Regional Universitaire de Nancy Hopital Brabois
RECRUITING
Vandœuvre-lès-nancy
Germany
Agaplesion Markus Krankenhaus
RECRUITING
Frankfurt Am Main
Hamburger Forschungsinstitut Fuer Chronisch Entzuendliche Darmerkrankungen (HaFCED e.K.)
RECRUITING
Hamburg
Medizinische Hochschule Hannover, Hannover Medical School
NOT_YET_RECRUITING
Hanover
Praxis fur Gastroenterologie
RECRUITING
Heidelberg
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
RECRUITING
Kiel
St. Marien- und St. Annastiftskrankenhaus
RECRUITING
Ludwigshafen
Universitaetsklinikum Mannheim GmbH
NOT_YET_RECRUITING
Mannheim
Universitaetsklinikum Tuebingen
RECRUITING
Tübingen
University Hospital Of Ulm, Universitatsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Greece
Evaggelismos Hospital (Evangelismos Hospital)-University of Athens
RECRUITING
Athens
G.N.A. Gennimatas
RECRUITING
Athens
Sotiria General Hospital of Athens
RECRUITING
Athens
University Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Patras
RECRUITING
Pátrai
Hungary
Clinexpert
RECRUITING
Budapest
Pannonia Maganorvosi Centrum Kft.
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Mohacsi Korhaz
RECRUITING
Mohács
Javorszky Odon Korhaz
RECRUITING
Vác
Israel
Assuta Ashdod University Hospital
NOT_YET_RECRUITING
Ashdod
Soroka Mc
NOT_YET_RECRUITING
Beersheba
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
NOT_YET_RECRUITING
Ramat Gan
Italy
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
RECRUITING
Bologna
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
RECRUITING
Milan
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
RECRUITING
Palermo
Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Rome
IRCCS Istituto clinico humanitas - Humanitas Mirasole spa
RECRUITING
Rozzano
AO Ordine Mauriziano di Torino
NOT_YET_RECRUITING
Torino
Japan
Fukuoka University Hospital
RECRUITING
Fukuoka
Kansai Medical University Hospital
RECRUITING
Hirakata
The jikei University Hospital
RECRUITING
Minato
Kitasato University Kitasato Institute Hospital
RECRUITING
Minato-ku
Kyorin University Hospital
RECRUITING
Mitaka
Saga University Hospital
RECRUITING
Saga
Toho University Sakura Medical Center
RECRUITING
Sakura
Sapporo Medical University Hospital
RECRUITING
Sapporo
Netherlands
St. Elisabeth Ziekenhuis
NOT_YET_RECRUITING
Tilburg
Norway
Vestre Viken HF - Baerum Sykehus
RECRUITING
Drammen
Akershus University Hospital
RECRUITING
Lorenskog
Oslo Univeristy Hospital Ulleval Hospital
RECRUITING
Oslo
Poland
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
RECRUITING
Bydgoszcz
Centrum Medyczne Pratia Gdynia
RECRUITING
Gdynia
AmiCare Sp. z o.o. Sp. k.
NOT_YET_RECRUITING
Lodz
Centrum Medyczne Med-Gastr
NOT_YET_RECRUITING
Lodz
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
RECRUITING
Lodz
Medrise sp. z o.o
RECRUITING
Lublin
Centrum Medyczne MedykSp. z o.o. Sp. K.
RECRUITING
Rzeszów
Korczowski Bartosz, Gabinet Lekarski
RECRUITING
Rzeszów
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
Gastromed Kopon, Zmudzinski i Wspolnicy Sp.j. Specjalistyczne Centrum Gastrologii i Endoskopii Specjalistyczne Gabinety Lekarskie
RECRUITING
Torun
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
NOT_YET_RECRUITING
Tychy
Panstwowy Instytut Medyczny MSWiA
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Wojskowy Instytut Medyczny
NOT_YET_RECRUITING
Warsaw
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy
NOT_YET_RECRUITING
Wroclaw
Centrum Medyczne Melita Medical
RECRUITING
Wroclaw
PlanetMed Sp. z o.o.
RECRUITING
Wroclaw
ETG Zamosc
NOT_YET_RECRUITING
Zamość
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Kosin University Gospel Hospital
NOT_YET_RECRUITING
Busan
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Yeungnam University Medical Center
NOT_YET_RECRUITING
Daegu
Asan Medical Center (AMC)
RECRUITING
Seoul
Chung-Ang University Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Yonsei University Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Romania
Clinica Medicum
NOT_YET_RECRUITING
Bucharest
Clinical Hospital Colentina-Spitalul Clinic Colentina
RECRUITING
Bucharest
Delta Health Care
RECRUITING
Bucharest
Spital Clinic Dr I Cantacuzino
RECRUITING
Bucharest
Spitalul de Oncologie Monza - Soseaua Gheorghe Ionescu Sisesti
RECRUITING
Bucharest
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
RECRUITING
Timișoara
Slovakia
Fakultna nemocnica F. D. Roosevelta
RECRUITING
Banská Bystrica
Cliniq s. r. o.
RECRUITING
Bratislava
Endomed
RECRUITING
Košice
Fakultna Nemocnica s poliklinikou Nove Zamky
RECRUITING
Nové Zámky
Accout Center, s.r.o.- Gastroenterologicka ambulancia
RECRUITING
Šahy
Spain
Hospital Universitario de Fuenlabrada
NOT_YET_RECRUITING
Fuenlabrada
Hospital Juan Ramon Jimenez
NOT_YET_RECRUITING
Huelva
Hospital General Universitario Gregorio Maranon (HGUGM)
NOT_YET_RECRUITING
Madrid
Switzerland
University Hospital Basel
NOT_YET_RECRUITING
Basel
Taiwan
Changhua Christian Hospital (CCH)
NOT_YET_RECRUITING
Changhua
Kaohsiung Medical University Hospital
WITHDRAWN
Kaohsiung City
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital (NTUH)
WITHDRAWN
Taipei
National Taiwan University Hospital (NTUH)
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
WITHDRAWN
Taoyuan
United Kingdom
South Eastern Health and Social Care Trust - The Ulster Hospital
RECRUITING
Belfast
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Clinical Research Centre - Barts Health NHS Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
London
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-03-29
Estimated Completion Date: 2027-08-04
Participants
Target number of participants: 207
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Takeda