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A Study to Assess the Efficacy and Safety of Induction 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 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).
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction 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
425
Start Date
2025-05-12
Completion Date
2033-04-30
Last Updated
2026-10-26
Healthy Volunteers
No
Interventions
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo
Placebo matching IV afimkibart.
Locations (208)
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
FOMAT Medical Research - 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
NYU Langone Long Island Clinical Research Associates
Lake Success, 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
Tyler Research Institute, LLC
Tyler, 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
Virginia Mason Medical Center
Seattle, Washington, United States
Washington Gastroenterology
Tacoma, Washington, United States
University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, United States
Instituto Medico CER
Quilmes, Argentina
CICE 9 de Julio
San Miguel de Tucumán, Argentina
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Coral Sea Clinical Research Institute
Mackay, Queensland, Australia
Lyell McEwin Hospital
Adelaide, South Australia, Australia
Footscray Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
CHU St Pierre (St Pierre)
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Newdata Clinical Trials
Aracaju, Sergipe, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
Panagyurishte, Bulgaria
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, Bulgaria
Barrie GI Associates
Barrie, Ontario, Canada
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
London Health Sciences Centre Uni Campus
London, Ontario, Canada
LDDI Clinical Trials Inc.
London, Ontario, Canada
Toronto Immune and Digestive Health Institute
North YORK, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Medicina de Precisión - Celerity
Las Condes, Chile
Medwal
Santiago, Chile
Centro de Investigación Clínica UC-CICUC
Santiago, Chile
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Jinhua municipal central hospital
Jinhua, Zhejiang, China
Beijing Union Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
Guangzhou First People's Hospital
Guangzhou, China
Zhujiang Hospital, Southern Medical University
Guangzhou, China