A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT06819878 · 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 treat-through study will evaluate the efficacy and safety of induction and maintenance 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
- 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, definite low-grade or high-grade colonic dysplasia
- 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 (Gastroenterology Associates of Dothan) - Dothan - Dothan, Alabama, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Arizona Digestive Health, P.C (ADH) - Sun City, Arizona, United States
- University of Arizona-CATS Research Center - Tucson, Arizona, United States
- Valley View Internal Medicine - Garden Grove, California, United States
- 310 Clinical Research - Inglewood, California, United States
- UCSD Medical Center - La Jolla, California, United States
- University of California San Diego - La Jolla, California, United States
- Gastro Care Associates - Lancaster, California, United States
- Om Research LLC - Lancaster, California, United States
- United Gastroenterologists - Los Alamitos, California, United States
- Acclaim Clinical Research, Inc. - San Diego, California, United States
- Kaiser Permanente - San Francisco, California, United States
- UCSF/Medical Center at Mount Zion - San Francisco, California, United States
- Rocky Mountain Gastroenterology - Littleton, Colorado, United States
- Peak Gastroenterology Surgery Center - Lone Tree, Colorado, United States
- Access Research Institute - Brooksville, Florida, United States
- Gastro Florida - Clearwater, Florida, United States
- HealthMed Clinical Center Inc. - Coral Gables, Florida, United States
- Hi Tech and Global Research, LLC - Coral Gables, Florida, United States
- The Sister Life Research - Hialeah, Florida, United States
- NeoClinical Research - Hialeah, Florida, United States
- Clinical Research of Osceola, LLC - Kissimmee, Florida, United States
- Florida Research Institute - Lakewood - Lakewood Rch, Florida, United States
- LCC Medical Research Institute, LLC - Miami, Florida, United States
- Ambert Medical Research - Miami, Florida, United States
- Orlando Regional Healthcare - Orlando, Florida, United States
- Nodal Medical Center Research - NMC - Tampa, 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
- Theia Clinical Research Centers, LLC - Temple Terrace, Florida, United States
- Cleveland Clinic Florida - Weston, Florida, United States
- Florida Medical Clinic - Orlando Health - Zephyrhills, Florida, United States
- Digestive Healthcare of Georgia - 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
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Illinois Gastroenterology Group-Glenview powered by GI Alliance - Glenview, Illinois, United States
- GI Alliance - Gurnee - Gurnee, Illinois, United States
- Indiana University Health University Hospital - Indianapolis, Indiana, United States
- Gastroenterology Health Partners, PLLC - New Albany, Indiana, United States
- Kansas Gastroenterology, LLC under Clinical Trials Network - Wichita, Kansas, United States
- Tri-State Gastroenterology Associates - Crestview Hills, Kentucky, United States
- Gastroenterology Health Partners, PLLC - Louisville, Kentucky, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Boston University - Boston, Massachusetts, United States
- Michigan Center of Medical Research - Farmington Hills, Michigan, United States
- Gastroenterology Associates and Endoscopy Center of North Mississippi - Oxford, Mississippi, United States
- Delta Gastroenterology & Endoscopy Center - Southaven, Mississippi, United States
- Las Vegas Clinical Trials, LLC - North Las Vegas, Nevada, United States
- Mount Sinai Hospital - IBD Clinical Center - New York, New York, United States
- Lenox Hill Hospital - 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
- Mainstreet - Richmond Hill Clinic - Richmond Hill, New York, United States
- Gastroenterology Group Of Rochester, LLP - Rochester, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- Atrium Health, Carolinas Healthcare System - Charlotte, North Carolina, United States
- Omega Research North Carolina, LLC - Fuquay-Varina, North Carolina, United States
Showing 60 of 374 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →