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RECRUITING
NCT06819891
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

DRUG

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

And 108 more locations on ClinicalTrials.gov