A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT06588855 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
AfimkibartPlacebo
What this trial is about
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Who can take part
Age range
16 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan - Dothan, Alabama, United States
- Mayo Clinic Hospital - Scottsdale, Arizona, United States
- Arizona Digestive Health, P.C (ADH) - Sun City, Arizona, United States
- Om Research LLC - Apple Valley, California, United States
- Valley View Internal Medicine - Garden Grove, California, United States
- Gastro Care Associates - Lancaster, California, United States
- University of Southern California - Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education - Newport Beach, California, United States
- Stanford Medicine Outpatient Center - Redwood City, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Hi Tech and Global Research, LLC - Coral Gables, Florida, United States
- The Sister Life Research - Hialeah, Florida, United States
- LCC Medical Research Institute, LLC - Miami, Florida, United States
- Allied Biomedical Research Institute - Miami, Florida, United States
- Ambert Medical Research - Miami, Florida, United States
- Integrity Trials LLC - Orlando, Florida, United States
- Digestive and Liver Center of Florida - Orlando, Florida, United States
- Advanced Medical Research Center - Port Orange, Florida, United States
- University of South Florida School of Medicine Morsani Center for Advanced Health Care - Tampa, Florida, United States
- Guardian Angel Research Center, LLC - Tampa, Florida, United States
- Santos Research Center, CORP - Tampa, Florida, United States
- Cleveland Clinic Florida - Weston, Florida, United States
- Randomize Now, LLC - Atlanta, Georgia, United States
- Atlanta Gastroenterology Associates - Atlanta, Georgia, United States
- Gastroenterology Associates of Central Georgia - Macon, Georgia, United States
- Grand Teton Research Group, PLLC - Idaho Falls, Idaho, United States
- Illinois Gastroenterology Group-Glenview powered by GI Alliance - Glenview, Illinois, United States
- GI Alliance - Gurnee - Gurnee, Illinois, United States
- Gastro Health Partners, LLC - New Albany, Indiana, United States
- Kansas Gastroenterology, LLC under Clinical Trials Network - Wichita, Kansas, United States
- One GI: GHP - Gastroenterology Health Partners Louisville - Louisville, Kentucky, United States
- Louisiana Research Center - GastroIntestinal Associates - Shreveport, Louisiana, United States
- Allied Gastrointestinal Associates, PA - Flowood, Mississippi, United States
- Delta Gastroenterology & Endoscopy Center - Southaven, Mississippi, United States
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center - Lebanon, New Hampshire, United States
- Ellipsis Research Group - Brooklyn, New York, United States
- NYU Inflammatory Bowel Disease Center - New York, New York, United States
- Weill Cornell Medical College - New York, New York, United States
- DiGiovanna Inst for Med Ed&Res - North Massapequa, New York, United States
- Queens Village Medical Care - Queens Village, New York, United States
- Gastroenterology Group Of Rochester, LLP - Rochester, New York, United States
- James J Peters Veterans Administration Medical Center - NAVREF - The Bronx, New York, United States
- Charlotte Gastroenterology and Hepatology, P.L.L.C - Charlotte, North Carolina, United States
- Omega Research North Carolina, LLC - Fuquay-Varina, North Carolina, United States
- Peters Medical Research (PMR), LLC - High Point, North Carolina, United States
- Dayton Gastroenterology, Inc. - Beavercreek, Ohio, United States
- University of Cincinnati Hospital - Cincinnati, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Ohio Gastroenterology Group - Columbus, Ohio, United States
- Ohio State University - Columbus, Ohio, United States
- Gastro Intestinal Research Institute of Northern Ohio - Westlake, Ohio, United States
- Frontier Clinical Re search, LLC - Uniontown, Pennsylvania, United States
- University Gastroenterology - Providence, Rhode Island, United States
- Gastroenterology Associates - Greenville, South Carolina, United States
- Gastro One - Cordova, Tennessee, United States
- Uni of Texas Medical Branch - Galveston, Texas, United States
- GI Alliance - Garland, Texas, United States
- Amel Med LLC - Georgetown, Texas, United States
- Cano Medical Center - Harlingen, Texas, United States
- Texas Digestive Specialists - Harlingen, Texas, United States
Showing 60 of 200 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →