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
Launched by TAKEDA · Feb 2, 2024
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called TAK-279 to see if it can help reduce inflammation in the bowels of people with moderately to severely active ulcerative colitis (UC). The main goal is to determine if TAK-279 is more effective than a placebo, which is an inactive treatment. Participants will take either TAK-279 or a placebo for up to 3 months, and then everyone will receive TAK-279 for an additional year. Throughout the study, participants will visit the clinic several times to monitor their health and any side effects.
To participate in the trial, individuals need to be between 18 and 75 years old and have been diagnosed with UC for at least 30 days. They must also have experienced insufficient relief from previous treatments. However, people with certain other types of bowel diseases or serious complications from UC, like strictures or the need for surgery, cannot join. This study is currently looking for participants, and by joining, they will contribute to important research that could improve treatment for ulcerative colitis.
Gender
ALL
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.
About Takeda
Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heidelberg, Victoria, Australia
Tilburg, , Netherlands
Perth, Western Australia, Australia
Aalborg, , Denmark
Heraklion, Crete, Greece
Paris, , France
Seattle, Washington, United States
Louisville, Kentucky, United States
Huelva, , Spain
Melbourne, Victoria, Australia
Bedford Park, South Australia, Australia
Woodville, South Australia, Australia
Tuebingen, , Germany
Basel, , Switzerland
Sapporo, Hokkaido, Japan
Seoul, , Korea, Republic Of
Kaohsiung, , Taiwan
Seoul, , Korea, Republic Of
Sakura, Chiba, Japan
Chengdu, Sichuan, China
Lorenskog, Akershus, Norway
London, Ontario, Canada
New Westminster, British Columbia, Canada
Taichung City, , Taiwan
Leuven, , Belgium
Jerusalem, , Israel
Decatur, Georgia, United States
Wuhan, Hubei, China
Tianjin, Tianjin, China
Shanghai, Shanghai, China
Budapest, , Hungary
Changsha, Hunan, China
Rome, , Italy
Fukuoka, , Japan
Frankfurt Am Main, , Germany
Calgary, Alberta, Canada
Budapest, , Hungary
Seoul, , Korea, Republic Of
Saga, , Japan
Athens, , Greece
Vac, , Hungary
Minato Ku, Tokyo, Japan
Hradec Kralove, , Czechia
Tyler, Texas, United States
Fuenlabrada, , Spain
Palermo, , Italy
Los Angeles, California, United States
Tampa, Florida, United States
London, Ontario, Canada
Daegu, , Korea, Republic Of
Nedlands, Western Australia, Australia
North Massapequa, New York, United States
Koge, , Denmark
Banska Bystrica, , Slovakia
Busan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
Brno, , Czechia
Changhua City, Changhua County, Taiwan
Seoul, , Korea, Republic Of
Patras, Achaia, Greece
Mohacs, , Hungary
Las Vegas, Nevada, United States
Wuhan, Hubei, China
Sydney, New South Wales, Australia
Brno, , Czechia
Praha 5, , Czechia
Warsaw, , Poland
Atlanta, Georgia, United States
Daegu, , Korea, Republic Of
Murrieta, California, United States
Glen Burnie, Maryland, United States
Belfast, , United Kingdom
Sofia, , Bulgaria
Ashdod, , Israel
Lakeland, Florida, United States
Seoul, , Korea, Republic Of
Miami Lakes, Florida, United States
Szczecin, Zachodniopomorskie, Poland
London, Greater London, United Kingdom
Houston, Texas, United States
Madrid, , Spain
Sofia, , Bulgaria
Ceske Budejovice, , Czechia
Montreal, Quebec, Canada
Mannheim, , Germany
Zamosc, , Poland
Bydgoszcz, Kujawsko Pomorskie, Poland
Liberty, Missouri, United States
Shanghai, Shanghai, China
Orange, California, United States
Iowa City, Iowa, United States
Clermont Ferrand, , France
Providence, Rhode Island, United States
Lodz, , Poland
Greenville, South Carolina, United States
Changzhou, Jiangsu, China
Bucharest, , Romania
Cambridge, , United Kingdom
Milan, , Italy
Gdynia, Pomorskie, Poland
Kiel, , Germany
Hannover, , Germany
Warsaw, , Poland
Clearwater, Florida, United States
Naples, Florida, United States
New York, New York, United States
Bellaire, Texas, United States
Heidelberg, , Germany
Rozzano, , Italy
Tampa, Florida, United States
Oklahoma City, Oklahoma, United States
Brussels, Anderlecht / Region Capitale De Bruxelles/ Brussel, Belgium
Montreal, Quebec, Canada
Ostrava Poruba, , Czechia
Praha, , Czechia
Odense, Syddanmark, Denmark
Esbjerg, , Denmark
Hillerod, , Denmark
Hvidovre, , Denmark
Neuilly Sur Seine, , France
Nice Cedex 3, , France
Saint Etienne, , France
Vandoeuvre Les Nancy, , France
Hamburg, , Germany
Ludwigshafen, , Germany
Ulm, , Germany
Athens, Attiki, Greece
Athens, , Greece
Budapest, , Hungary
Bologna, , Italy
Hirakata, Osaka, Japan
Minato, Tokyo, Japan
Mitaka City, Tokyo, Japan
Wonju, Gangwon, Korea, Republic Of
Drammen, Gjettum, Norway
Oslo, , Norway
Tromso, , Norway
Wroclaw, Dolnolskie, Poland
Wroclaw, Dolnoslaskie, Poland
Torun, Kujawsko Pomo, Poland
Warszawa, Mazowieckie, Poland
Lodz, , Poland
Lublin, , Poland
Rzeszow, , Poland
Rzeszow, , Poland
Timisoara, Jud Timis, Romania
Bucharest, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Bratislava, , Slovakia
Kosice, , Slovakia
Nove Zamky, , Slovakia
London, E1 2at, United Kingdom
London, , United Kingdom
Seoul, , Korea, Republic Of
Kingswood, New South Wales, Australia
Melbourne, Victoria, Australia
Halifax, Nova Scotia, Canada
Guangzhou, Guangdong, China
Shenyang, Liaoning Sheng, China
Shanghai, , China
Chambray Les Tours, , France
Amsterdam, , Netherlands
Lodz, Lodzkie, Poland
Tychy, , Poland
Wroclaw, , Poland
Taipei City, Zhongzheng District, Taiwan
Taoyuan City, , Taiwan
Guangzhou, , China
Hangzhou, , China
Zhejiang, , China
Murdoch, Western Australia, Australia
Vaughan, Ontario, Canada
Shenzhen, Gangdong, China
Shijiazhuang, Hebei Sheng, China
Tianjin, Jiangsu, China
Ostrava Poruba, , Czechia
Nice Cedex 3, , France
Vandoeuvre Les Nancy, , France
Rome, , Italy
Torino, , Italy
Oslo, , Norway
Bucuresti, , Romania
Banska Bystrica, , Slovakia
Murdoch, , Australia
Sliven, , Bulgaria
South Brisbane, Queensland, Australia
Epping, , Australia
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Horovice, Stredocesky, Czechia
Brno, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Usti Nad Labem, , Czechia
Beer Sheva, , Israel
Ramat Gan, , Israel
Sahy, , Slovakia
Sofia, , Bulgaria
Sofia, , Bulgaria
Chongqing, Chongqing Sheng, China
Prague 5, , Czechia
Bucuresti, , Romania
Guangzhou, Guangdong, China
Kaohsiung, Zhongzheng District, Taiwan
London, , United Kingdom
Taipei City, Zhongzheng District, Taiwan
Brussels, , Belgium
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported