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ACTIVE NOT RECRUITING
NCT06589986
PHASE3

A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

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 Ulcerative Colitis

Key Details

Gender

All

Age Range

16 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-09-17

Completion Date

2031-01-30

Last Updated

2026-09-14

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. Placebo matching SC afimkibart.

Locations (184)

Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan

Dothan, Alabama, United States

Om Research LLC

Lancaster, California, United States

University of California Irvine

Orange, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Access Research Institute

Brooksville, Florida, United States

Gastro Florida

Clearwater, Florida, United States

Clinical Research of Osceola, LLC

Kissimmee, Florida, United States

Auzmer Research

Lakeland, Florida, United States

Florida Research Institute - Lakewood

Lakewood Rch, Florida, United States

Homestead Associates in Research, Inc.

Miami, Florida, United States

Allied Biomedical Research Institute, Inc

Miami, Florida, United States

Miami Beach Clinical Research Center

Miami Beach, Florida, United States

Theia Clinical Research Centers, LLC

Tampa, Florida, United States

Florida Medical Clinic

Zephyrhills, Florida, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

The University of Chicago

Chicago, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, United States

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, United States

Gastroenterology Health Partners, PLLC

Louisville, Kentucky, United States

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, United States

Brigham & Womens Hosp

Boston, Massachusetts, United States

Boston University

Boston, Massachusetts, United States

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, United States

Intercity Gastroenterology

Fresh Meadows, New York, United States

Pioneer Clinical Research NY

New York, New York, United States

Digestive Health Partners, PA

Asheville, North Carolina, United States

Peters Medical Research (PMR), LLC

High Point, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Gastroenterology Group

Columbus, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, United States

University Gastroenterology

Providence, Rhode Island, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Gastro One

Cordova, Tennessee, United States

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, United States

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

GI Alliance

Garland, Texas, United States

TDDC dba GI Alliance Research

Mansfield, Texas, United States

Carta - Clinical Associates In Research Therapeutics Of America;LLC

San Antonio, Texas, United States

Southern Star Research Institute, 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

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

Chesapeake, Virginia, United States

Gastroenterology Consultants of SWVA

Roanoke, Virginia, United States

CIPREC Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, Argentina

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Lyell McEwin Hospital

Adelaide, South Australia, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medizinische Universität Innsbruck

Innsbruck, Austria

Barmherzige Brüder Wien

Vienna, Austria

CHC MontLégia

Liège, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

Hospital de Clinicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, Brazil

MHAT St. Ivan Rilski

Gorna Oryahovitsa, Bulgaria

South Edmonton Gastroenterology

Edmonton, Alberta, Canada

Hospital Guillermo Grant Benavente

Concepción, Chile

Clinica Universidad de Los Andes

Santiago, Chile

Medwal

Santiago, Chile

Peking University Third Hospital

Beijing, China

Binzhou Medical university hospital

Binzhou, China

the First Hospital of Jilin University

Changchun, China

Sichuan Provincial People's Hospital

Chengdu, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The sixth affiliated hospital of Sun Yat-Sen University

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Huizhou First Hospital

Huizhou, China

Jinhua municipal central hospital

Jinhua, China

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, China

Nanjing 1st Hospital

Nanjing, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Peking University Shenzhen Hospital

Shenzhen, China

Hebei Medical University - The Second Hospital

Shijiazhuang, China

Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Ren Min Hospital Affiliated Wu Han University

Wuhan, China

Wuxi People's Hospital

Wuxi, China

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhuzhou Central Hospital

Zhuzhou, China

Borzan Polyclinic

Osijek, Croatia

SurGal Clinic s.r.o.

Brno, Czechia

Nemocnice Ceske Budejovice a.s.

České Budějovice, Czechia

Gastroenterologie s.r.o.

Hradec Králové, Czechia

Herlev Hospital

Herlev, Denmark

CHU Amiens - Hopital Sud

Amiens, France

CHU Dijon Bourgogne Hôpital François Mitterand

Dijon, France

CH Dptal Les Oudairies

La Roche-sur-Yon, France

CHRU de Lille - Hopital Claude Huriez

Lille, France

Hopital Nord

Marseille, France

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, France

CHU Nice - Hopital de l'Archet 2

Nice, France

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, France

And 84 more locations on ClinicalTrials.gov