A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Launched by HOFFMANN-LA ROCHE · Sep 6, 2024
Trial Information
Current as of August 31, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called RO7790121 to see how well it works and how safe it is for people with moderately to severely active ulcerative colitis (UC), which is a condition that causes inflammation in the digestive tract. The trial will compare RO7790121 to a placebo, which is a treatment that looks like the real medication but does not contain any active ingredients. This study is important because it aims to help people who have not responded well to other treatments for UC.
To participate in the trial, individuals must have a confirmed diagnosis of ulcerative colitis and show moderate to severe symptoms. They need to weigh at least 40 kilograms and have not had adequate relief from at least one previous treatment. However, some people are not eligible, such as those with certain complications from UC, other digestive conditions, or a history of specific infections or cancers. Participants in the trial can expect to receive either the study drug or a placebo, and they will be closely monitored throughout the trial to assess their health and the effectiveness of the treatment. This study is currently recruiting participants of all genders between the ages of 18 and 80.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Confirmed diagnosis of UC
- • Moderately to severely active UC assessed by mMS
- • Bodyweight \>= 40 kilogram (kg)
- • Up to date with colorectal cancer (CRC) screening performed according to local standards
- • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- • Males and females of childbearing potential must meet protocol criteria for contraception requirements
- Exclusion Criteria:
- • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- • Presence of an ostomy or ileoanal pouch
- • Current diagnosis or suspicion of primary sclerosing cholangitis
- • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tyler, Texas, United States
Madrid, , Spain
Boston, Massachusetts, United States
London, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Irvine, California, United States
Baltimore, Maryland, United States
Chicago, Illinois, United States
Zephyrhills, Florida, United States
Woolloongabba, Queensland, Australia
Bruxelles, , Belgium
Halifax, Nova Scotia, Canada
Hiroshima, , Japan
Santander, Cantabria, Spain
Herlev, , Denmark
Hokkaido, , Japan
Bucharest, , Romania
Ulm, , Germany
Liverpool, , United Kingdom
Sevilla, , Spain
Dudley, , United Kingdom
Adelaide, South Australia, Australia
Yamagata, , Japan
Macon, Georgia, United States
Osaka, , Japan
Porto, , Portugal
Nashville, Tennessee, United States
Orange, California, United States
Valencia, , Spain
Lille, , France
Shanghai, , China
Cambridge, , United Kingdom
Pierre Benite, , France
Nagasaki, , Japan
Innsbruck, , Austria
Epping, Victoria, Australia
Padova, Veneto, Italy
Pathumthani, , Thailand
Fukuoka, , Japan
Liège, , Belgium
Kanagawa, , Japan
Kragujevac, , Serbia
Utrecht, , Netherlands
Vancouver, Washington, United States
Nijmegen, , Netherlands
Hradec Kralove, , Czechia
Norman, Oklahoma, United States
Budapest, , Hungary
Murdoch, Western Australia, Australia
Mannheim, , Germany
Halle, , Germany
Gent, , Belgium
Wien, , Austria
Chongqing, , China
Arlington, Texas, United States
Changchun, , China
Germantown, Tennessee, United States
Torino, Piemonte, Italy
Amiens, , France
Fukuoka, , Japan
Surin, , Thailand
Roeselare, , Belgium
Budapest, , Hungary
Szekszard, , Hungary
Chengdu, , China
Chiba, , Japan
Roma, Lazio, Italy
Saga, , Japan
Marseille, , France
Mentor, Ohio, United States
Tyler, Texas, United States
Warszawa, , Poland
Frankfurt, , Germany
Indianapolis, Indiana, United States
Sydney, , Australia
Cleveland, Ohio, United States
Budapest, , Hungary
Nice, , France
Hefei, , China
Braga, , Portugal
Belgrade, , Serbia
Huntington, West Virginia, United States
Milano, Lombardia, Italy
Tokyo, , Japan
Budapest, , Hungary
Pessac, , France
Kagawa, , Japan
Saint Etienne, , France
Monterrey, Nuevo Leon, Mexico
Rennes, , France
Adelaide, South Australia, Australia
Fukuoka, , Japan
Jinhua, , China
Wuxi, , China
Zhuzhou, , China
Colorado Springs, Colorado, United States
Berlin, , Germany
Nowy Targ, , Poland
Olsztyn, , Poland
Frankfurt, , Germany
Pavia, Lombardia, Italy
La Roche Sur Yon, , France
Liege, , Belgium
Budapest, , Hungary
Ceske Budejovice, , Czechia
Hradec Kralove, , Czechia
Farmington Hills, Michigan, United States
Idaho Falls, Idaho, United States
Hyogo, , Japan
Tianjin, , China
Santiago, , Chile
Miami, Florida, United States
Saga, , Japan
Crestview Hills, Kentucky, United States
Tokyo, , Japan
Reims, , France
Shizuoka, , Japan
Ciudad Autonoma Buenos Aires, , Argentina
Chikushino Shi, , Japan
Osaka, , Japan
Piotrków Trybunalski, , Poland
South Brisbane, Queensland, Australia
Zhengzhou, , China
Aichi, , Japan
Osaka, , Japan
Clearwater, Florida, United States
Monroe, North Carolina, United States
Xi'an City, , China
Hefei, , China
Mesquite, Texas, United States
Vác, , Hungary
Oita, , Japan
Gifu, , Japan
Portimao, , Portugal
Lancaster, California, United States
Sao Paulo, , Brazil
Lisboa, , Portugal
Zamosc, , Poland
Lakeland, Florida, United States
Shenzhen, , China
Taipei City, Zhongzheng District, Taiwan
Sint Niklaas, , Belgium
Wuhan City, , China
Køge, , Denmark
Saitama, , Japan
New Albany, Indiana, United States
Asheville, North Carolina, United States
Dothan, Alabama, United States
Jaipur, Rajasthan, India
Cedar Park, Texas, United States
San Antonio, Texas, United States
Shizuoka, , Japan
Bratislava, , Slovakia
Taiyuan, , China
Fresh Meadows, New York, United States
Okayama Shi, , Japan
Dijon, , France
Guangzhou City, , China
Hradec Kralove, Hradec Králové, Czechia
New York, New York, United States
Fuzhou City, , China
Toulouse, , France
Edmonton, Alberta, Canada
Gorna Oryahovitsa, , Bulgaria
North Las Vegas, Nevada, United States
Nanjing, , China
Sosnowiec, , Poland
Johnson City, Tennessee, United States
Liberty, Missouri, United States
Binzhou, , China
Garland, Texas, United States
Shijiazhuang City, , China
Southlake, Texas, United States
Brooksville, Florida, United States
Santiago, , Chile
Miami Beach, Florida, United States
Providence, Rhode Island, United States
Wroc?Aw, , Poland
Toru?, , Poland
Nanchang City, , China
Pozna?, , Poland
Rzeszów, , Poland
Wroc?Aw, , Poland
Brno, , Czechia
San Diego, California, United States
Roanoke, Virginia, United States
Inglewood, California, United States
Tokyo, , Japan
Cordova, Tennessee, United States
Wuhan, , China
Chojnice, , Poland
Mansfield, Texas, United States
Mansfield, Texas, United States
New York, New York, United States
Wroc?Aw, , Poland
London, , United Kingdom
Warsaw, , Poland
Santa Clarita, California, United States
Woodbridge, Ontario, Canada
Neuilly Sur Seine, , France
Bratislava, , Slovakia
Chikushino Shi, , Japan
?ód?, , Poland
Jena, , Germany
Huizhou, , China
Shreveport, Louisiana, United States
Westlake, Ohio, United States
Tampa, Florida, United States
Dothan, Alabama, United States
Homestead, Florida, United States
Košice, , Slovakia
Brunswick, Ohio, United States
Tokyo, , Japan
Kissimmee, Florida, United States
Oxford, Mississippi, United States
Columbus, Ohio, United States
Chesapeake, Virginia, United States
Roanoke, Virginia, United States
Gent, , Belgium
Berlin, Be, Germany
Gyöngyös, , Hungary
Sun City, Arizona, United States
Miami, Florida, United States
Crestview Hills, Kentucky, United States
Boston, Massachusetts, United States
Pasadena, Texas, United States
Chesapeake, Virginia, United States
Santiago, , Chile
Bydgoszcz, , Poland
Belgrade, , Serbia
Beograd, , Serbia
Roma, Lazio, Italy
Hokkaido, , Japan
Louisville, Kentucky, United States
Plovdiv, , Bulgaria
Belgrade, , Serbia
Bangkok, , Thailand
Bangkok, , Thailand
Khon Kaen, , Thailand
Songkhla, , Thailand
Santa Maria Da Feira, , Portugal
San Francisco, California, United States
Lone Tree, Colorado, United States
Doral, Florida, United States
Miramar, Florida, United States
Tampa, Florida, United States
High Point, North Carolina, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Ciudad Autonoma Buenos Aires, , Argentina
Binzhou, , China
Guangzhou City, , China
Køge, , Denmark
Békéscsaba, , Hungary
Eger, , Hungary
Karczew, , Poland
Chiba, , Japan
Doral, Florida, United States
Flowood, Mississippi, United States
Concepcion, , Chile
Matera, Basilicata, Italy
Napoli, Campania, Italy
Rho, Lombardia, Italy
San Giovanni Rotondo, Lombardia, Italy
Gifu, , Japan
Pabianice, , Poland
Zamo??, , Poland
Viseu, , Portugal
Novi Sad, , Serbia
Osijek, , Croatia
Chicago, Illinois, United States
Zhengzhou, , China
Kanagawa, , Japan
Osaka, , Japan
??Czna, , Poland
Bia?Ystok, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Lakewood Ranch, Florida, United States
Guadalajara, Jalisco, Mexico
Wien, , Austria
Jerusalem, Bayit Vegan, Israel
Catanzaro, Calabria, Italy
Aomori, , Japan
Fukuoka, , Japan
Kagoshima Shi, , Japan
Ome Shi, , Japan
Osaka, , Japan
Tokyo, , Japan
Toru?, , Poland
Bratislava, , Slovakia
Ružomberok, , Slovakia
Liège, , Belgium
Fukuoka, , Japan
Fukuoka, , Japan
Hokkaido, , Japan
Hyogo, , Japan
Košice, , Slovakia
Changhua City, Changhua County, Taiwan
Surat City, Gujarat, India
Beijing City, , China
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported