A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease
Launched by TAKEDA · Jan 23, 2024
Trial Information
Current as of September 12, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new medication called TAK-279 to see if it can help reduce inflammation in the bowels of people with moderately to severely active Crohn's disease (CD). Crohn's disease is a long-term condition that causes inflammation in the digestive system, leading to symptoms like pain and diarrhea. The study aims to determine if TAK-279 works better than a placebo (a dummy treatment) in improving bowel health over 12 weeks. Participants will receive treatment for a total of 52 weeks and will have regular visits to the clinic to monitor their progress.
To join the study, participants must be between 18 and 75 years old and have a confirmed diagnosis of moderately to severely active Crohn's disease. They should have not responded well to or have had side effects from at least one previous treatment for their condition. During the trial, participants will have about 15 visits to the clinic, where doctors will check for any side effects and measure how well the treatment is working. This is an important opportunity for those struggling with Crohn's disease to potentially access a new treatment option.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female aged 18-75 years old with diagnosis of CD 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 CD assessed by SES-CD and CDAI.
- • 3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.
- Exclusion Criteria:
- • 1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.
- • 2. Have complications of CD that might require surgery during the study.
- • 3. Participants with a current ostomy.
- • 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
Philadelphia, Pennsylvania, United States
Adelaide, South Australia, Australia
Heidelberg, Victoria, Australia
Tilburg, Netherlands
Dallas, Texas, United States
Perth, Western Australia, Australia
Aalborg, Denmark
Heraklion, Crete, Greece
Paris, France
Seattle, Washington, United States
Louisville, Kentucky, United States
Rochester, New York, United States
Huelva, Spain
Zurich, Switzerland
Bedford Park, South Australia, Australia
Toronto, Ontario, Canada
Woodville, South Australia, Australia
Tuebingen, Germany
Madrid, Spain
Basel, Switzerland
Sendai, Miyagi, Japan
St. Gallen, Switzerland
Hamamatsu, Shizuoka, Japan
New York, New York, United States
Toyama, Japan
Kaohsiung, Taiwan
Sapporo, Hokkaido, Japan
New York, New York, United States
Kfar Saba, Israel
Seoul, Korea, Republic Of
Bern, Switzerland
Kaohsiung, Taiwan
Seoul, Korea, Republic Of
Nishinomiya City, Hyogo, Japan
Sakura, Chiba, Japan
Lorenskog, Akershus, Norway
London, Ontario, Canada
Iowa City, Iowa, United States
New Westminster, British Columbia, Canada
Gent, Belgium
Taichung City, Taiwan
Bucuresti, Romania
Leuven, Belgium
Decatur, Georgia, United States
Shanghai, Shanghai, China
Budapest, Hungary
Changsha, Hunan, China
Rome, Italy
Fukuoka, Japan
Copenhagen Nv, Denmark
Frankfurt Am Main, Germany
Taipei City, Taiwan
Calgary, Alberta, Canada
Budapest, Hungary
Roma, Italy
Saga, Japan
Athens, Greece
Roma, Italy
Takatsuki Shi, Osaka, Japan
Hradec Kralove, Czechia
Mentor, Ohio, United States
Tyler, Texas, United States
Fuenlabrada, Spain
Palermo, Italy
Tomball, Texas, United States
Los Angeles, California, United States
Tampa, Florida, United States
Kaohsiung, Taiwan
Guangzhou, Guangdong, China
London, Ontario, Canada
Seoul, Korea, Republic Of
North Massapequa, New York, United States
Oswiecim, Malopolskie, Poland
Koge, Denmark
Banska Bystrica, Slovakia
Busan, Korea, Republic Of
Hangzhou, Zhejiang, China
Oslo, Norway
Busan, Korea, Republic Of
Brno, Czechia
Changhua City, Changhua County, Taiwan
London, United Kingdom
Seoul, Korea, Republic Of
Shanghai, Shanghai, China
Patras, Achaia, Greece
Mohacs, Hungary
Las Vegas, Nevada, United States
Xiamen, Fujian, China
Sydney, New South Wales, Australia
Brno, Czechia
Las Vegas, Nevada, United States
Praha 5, Czechia
Warsaw, Poland
Atlanta, Georgia, United States
Garland, Texas, United States
Victoria, Texas, United States
Greenville, South Carolina, United States
Daegu, Korea, Republic Of
Murrieta, California, United States
Glen Burnie, Maryland, United States
Vancouver, British Columbia, Canada
Belfast, United Kingdom
Sofia, Bulgaria
Wroclaw, Dolnoslaskie, Poland
Takatsuki Shi, Osaka, Japan
San Antonio, Texas, United States
Lakeland, Florida, United States
Miami Lakes, Florida, United States
New York, New York, United States
Szczecin, Zachodniopomorskie, Poland
Cambridge, Cambridgeshire, United Kingdom
Houston, Texas, United States
Hamamatsu City, Shizuoka, Japan
Madrid, Spain
Sofia, Bulgaria
Toronto, Ontario, Canada
Marrero, Louisiana, United States
Ceske Budejovice, Czechia
Liege, Belgium
Montreal, Quebec, Canada
Mannheim, Germany
Zamosc, Poland
Amsterdam, Netherlands
Morioka, Iwate, Japan
Bucuresti, Romania
Bydgoszcz, Kujawsko Pomorskie, Poland
Kissimmee, Florida, United States
Montpellier, France
Liberty, Missouri, United States
Orange, California, United States
Iowa City, Iowa, United States
Dublin, Ohio, United States
Changhua City, Taiwan
Clermont Ferrand, France
Providence, Rhode Island, United States
Lodz, Poland
Bucharest, Romania
Mansfield, Texas, United States
Gdynia, Pomorskie, Poland
Wroclaw, Poland
Kiel, Germany
Hannover, Germany
Tokyo, Japan
New York, New York, United States
Warsaw, Poland
Norwich, Norfolk, United Kingdom
Clearwater, Florida, United States
Naples, Florida, United States
New York, New York, United States
Oklahoma City, Oklahoma, 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
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
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
Bratislava, Slovakia
Kosice, Slovakia
Nove Zamky, Slovakia
London, E1 2at, United Kingdom
London, United Kingdom
Kingswood, New South Wales, Australia
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Garden Grove, California, United States
Lakeland, Florida, United States
Orangeburg, South Carolina, United States
Fort Worth, Texas, United States
Chesapeake, Virginia, United States
Melbourne, Victoria, Australia
Bruxelles, Belgium
Halifax, Nova Scotia, Canada
Chongqing, Chongqing Sheng, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenyang, Liaoning Sheng, China
Shenyang, Liaoning Sheng, China
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Zhejiang, Zhejiang, China
Shanghai, China
Prague, Czechia
Praha 9, Czechia
Chambray Les Tours, France
Neuilly Sur Seine, France
Toulouse Cedex 09, France
Toulouse, France
Vandoeuvre Les Nancy, France
Ludwigshafen, Germany
Athens, Attiki, Greece
Budapest, Hungary
Milano, Italy
Milano, Italy
Roma, Italy
Torino, Italy
Morioka, Iwate, Japan
Kamakura Shi, Kanagawa, Japan
Geleen, Limburg, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Drammen, Akershus, Norway
Lodz, Lodzkie, Poland
Szczecin, Zachodniopomorskie, Poland
Bialystok, Poland
Rzeszow, Poland
Tychy, Poland
Warsaw, Poland
Wroclaw, Poland
Bucharest, Romania
Las Palmas De Gran Canaria, Spain
Bern, Switzerland
Taipei City, Zhongzheng District, Taiwan
Taoyuan City, Taiwan
Harrow, Middlesex, United Kingdom
Coventry, West Midlands, United Kingdom
Newcastle, United Kingdom
Iowa City, Iowa, United States
Fort Worth, Texas, United States
Vancouver, British Columbia, Canada
Shanghai, Shanghai, China
Guangzhou, China
Hangzhou, China
Zhejiang, China
Frankfurt, Germany
Amsterdam, Netherlands
Drammen, Norway
Szczecin, Zachodniopomorskie, Poland
Murdoch, Western Australia, Australia
Banska Bystrica, Slovakia
Dallas, Texas, United States
Mansfield, Texas, United States
Montpellier, France
Vandoeuvre Les Nancy, France
Bologna, Italy
Bucharest, Romania
Brussels, Anderlecht / Region Capitale De Bruxelles/ Brussel, Belgium
Toulouse Cedex 09, France
Toulouse, France
Bydgoszcz, Poland
London, E1 2at, United Kingdom
Tokyo, Japan
Sliven, Bulgaria
Kaohsiung, Taiwan
Adelaide, South Australia, Australia
Providence, Rhode Island, United States
South Brisbane, Queensland, Australia
Epping, Australia
Nedlands, Australia
Plovdiv, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Toronto, Ontario, Canada
Horovice, Stredocesky, Czechia
Brno, Czechia
Ostrava, Czechia
Pardubice, Czechia
Praha, Czechia
Usti Nad Labem, Czechia
Athens, Attiki, Greece
Beer Sheva, Israel
Jerusalem, Israel
Ramat Gan, Israel
Tel Aviv, Israel
Chiba, Japan
Sahy, Slovakia
Brussels, Belgium
London, United Kingdom
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported