A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT06819891 · 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 (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
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 CD
- Moderately to severely active CD
- Bodyweight \>= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion criteria
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
- 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 26 US states.
- Digestive Health Specialists of the Southeast - Dothan, Alabama, United States
- Sun City Clinical Research - Glendale, Arizona, United States
- Om Research LLC - Lancaster, California, United States
- Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education - Newport Beach, California, United States
- Empire Clinical Research - Pomona, California, United States
- Stanford Medicine Outpatient Center - Redwood City, California, United States
- Clinical Applications Laboratories, Inc. - San Diego, California, United States
- Amicis Research Center - Santa Clarita, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- J&A Clinical Research - Doral, Florida, United States
- Auzmer Research - Lakeland, Florida, United States
- Galenus Group Inc - Lehigh Acres, Florida, United States
- Homestead Associates in Research, Inc. - Miami, Florida, United States
- Allied Biomedical Research Institute, Inc - Miami, Florida, United States
- Rejuvaline Medical Research - Miami, Florida, United States
- Miami Beach Clinical Research Center - Miami Beach, Florida, United States
- Eminat Research Group - Miramar, Florida, United States
- Digestive and Liver Center of Florida - Orlando, Florida, United States
- Advanced Medical Research Center - Port Orange, Florida, United States
- Santos Research Center, CORP - Tampa, Florida, United States
- Cleveland Clinic Florida - Weston, Florida, United States
- Morehouse School Of Medicine - Atlanta, Georgia, United States
- The University of Chicago - Chicago, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Robley Rex VA Medical Center - Louisville, Kentucky, United States
- One GI: GHP - Gastroenterology Health Partners Louisville - Louisville, Kentucky, United States
- Baton Rouge General Medical Center - Baton Rouge, Louisiana, United States
- Louisiana Research Center - GastroIntestinal Associates - Shreveport, Louisiana, United States
- Mercy Medical Center - Baltimore, Maryland, United States
- Chevy Chase Clinical Research - Chevy Chase, Maryland, United States
- University of Massachusetts Memorial Medical Center - North Worcester, Massachusetts, United States
- Gastroenterology Associates of Western Michigan, P.L.C. - Wyoming, Michigan, United States
- Gastrointestinal Associates Research - Flowood, Mississippi, United States
- Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital - Columbia, Missouri, United States
- Specialists in Gastroenterology - St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center - Lebanon, New Hampshire, United States
- Virtua Crohns and Colitis Center - Moorestown, New Jersey, United States
- Robert Wood Johnson University Hospital - New Brunswick, New Jersey, United States
- Ellipsis Research Group - Brooklyn, New York, United States
- Intercity Gastroenterology - Fresh Meadows, New York, United States
- James J Peters Veterans Affairs Medical Center - The Bronx, New York, United States
- Digestive Disease Medicine of Central New York - Utica, New York, United States
- Charlotte Gastroenterology and Hepatology, P.L.L.C - Charlotte, North Carolina, United States
- Peters Medical Research (PMR), LLC - High Point, North Carolina, United States
- Clinical Inquest Center - Beavercreek, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- University Gastroenterology - Providence, Rhode Island, United States
- Gastro One - Cordova, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center - Dallas, Texas, United States
- GI Alliance - Fort Worth - Fort Worth, Texas, United States
- GI Alliance - Garland, Texas, United States
- Integrity Advanced Therapeutics PLLC - Houston, Texas, United States
- Texas Digestive Disease Consultants-Lubbock powered by GI Alliance - Lubbock, Texas, United States
- Carta - Clinical Associates In Research Therapeutics Of America;LLC - San Antonio, Texas, United States
- University of Texas Health Center at Tyler - Tyler, Texas, United States
- TDDC GI Alliance research Webster - Webster, Texas, United States
- GI Alliance-Richmond - Richmond, Virginia, United States
- University Physicians and Surgeons Inc, dba Marshall Health - Huntington, West Virginia, United States
Showing 60 of 199 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →