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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
Sponsor: Hoffmann-La Roche
Summary
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).
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
16 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-03-17
Completion Date
2033-12-31
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Locations (375)
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
Monroe Biomedical Research
Monroe, North Carolina, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
Digestive Disease Consultants
Brunswick, 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
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Gastro Health- Liberty
Liberty Township, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Gastroenterology Associates
Greenville, South Carolina, United States
Gastro One
Germantown, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Proactive El Paso,LLC
El Paso, Texas, United States
Amel Med LLC
Georgetown, Texas, United States
Cano Medical Center
Harlingen, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
TDDC dba GI Alliance Research
Mansfield, Texas, United States
SMS Clinical Research, LLC
Mesquite, Texas, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, United States
GI Alliance - Southlake
Southlake, Texas, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, United States
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, United States
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
Williamsburg, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
Hospital Britanico
Ciudad Autonoma Bs As, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia