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ACTIVE NOT RECRUITING
NCT06588855
PHASE3

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) 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 study will evaluate the efficacy and safety of induction therapy with 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 Study to Assess the Efficacy and Safety of Induction 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

350

Start Date

2024-12-11

Completion Date

2031-01-30

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

Afimkibart

Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.

DRUG

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Locations (168)

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

Dothan, Alabama, United States

Mayo Clinic Hospital

Scottsdale, Arizona, United States

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, United States

Om Research LLC

Apple Valley, California, United States

Valley View Internal Medicine

Garden Grove, California, United States

Gastro Care Associates

Lancaster, California, United States

Stanford Medicine Outpatient Center

Redwood City, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Hi Tech and Global Research, LLC

Coral Gables, Florida, United States

The Sister Life Research

Hialeah, Florida, United States

LCC Medical Research Institute, LLC

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

Integrity Trials LLC

Orlando, Florida, United States

Digestive and Liver Center of Florida

Orlando, Florida, United States

Advanced Medical Research Center

Port Orange, 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

Santos Research Center, CORP

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Randomize Now, LLC

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Glenview, Illinois, United States

GI Alliance - Gurnee

Gurnee, Illinois, United States

Gastro Health Partners, LLC

New Albany, Indiana, United States

Kansas Gastroenterology, LLC under Clinical Trials Network

Wichita, Kansas, United States

One GI: GHP - Gastroenterology Health Partners Louisville

Louisville, Kentucky, United States

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, United States

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, United States

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Ellipsis Research Group

Brooklyn, New York, United States

NYU Inflammatory Bowel Disease Center

New York, New York, United States

Weill Cornell Medical College

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

Gastroenterology Group Of Rochester, LLP

Rochester, New York, United States

Charlotte Gastroenterology and Hepatology, P.L.L.C

Charlotte, North Carolina, United States

Omega Research North Carolina, LLC

Fuquay-Varina, North Carolina, United States

Peters Medical Research (PMR), LLC

High Point, North Carolina, United States

Dayton Gastroenterology, Inc.

Beavercreek, 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

Ohio State University

Columbus, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, United States

Frontier Clinical Re search, LLC

Uniontown, Pennsylvania, United States

University Gastroenterology

Providence, Rhode Island, United States

Gastroenterology Associates

Greenville, South Carolina, United States

Gastro One

Cordova, Tennessee, United States

Uni of Texas Medical Branch

Galveston, Texas, United States

GI Alliance

Garland, Texas, United States

Amel Med LLC

Georgetown, Texas, United States

Cano Medical Center

Harlingen, Texas, United States

Texas Digestive Specialists

Harlingen, Texas, United States

GI Alliance - Bay Area Gastroenterology

Lubbock, Texas, United States

TDDC dba GI Alliance Research

Mansfield, Texas, United States

Southern Star Research Institute, LLC.

San Antonio, Texas, United States

Baylor Scott and White Medical Center

Temple, 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

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Emeritas Research Group

Lansdowne Town Center, Virginia, United States

Gastroenterology Consultants of SWVA

Roanoke, Virginia, United States

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

Instituto Medico CER

Quilmes, Argentina

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

CHU St Pierre (St Pierre)

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

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, Brazil

MC " Sveti Ivan Rilski Chudotvorets- 2010

Plovdiv, Bulgaria

"City Clinic UMHAC" EOOD

Sofia, Bulgaria

Barrie GI Associates

Barrie, Ontario, Canada

London Health Sciences Centre Uni Campus

London, Ontario, Canada

LDDI Clinical Trials Inc.

London, Ontario, Canada

TIDHI Innovation Inc.

Toronto, Ontario, Canada

CIUSSS-de-l?Est-de-l?Île-de-Montréal

Montreal, Quebec, Canada

Centro de Investigación Clínica UC-CICUC

Santiago, Chile

Beijing No.6 Hospital

Beijing, Beijing Municipality, China

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Third Xiangya Hospital Centrel South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Guangzhou First People's Hospital

Guangzhou, China

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, China

Huizhou Central People's Hospital

Huizhou, China

The First Affiliate Hospital of Guangxi Medical University

Nanning, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

The Affiliated Hospital of Medical College Qingdao University

Qingdao, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

First Affiliated Hospital of Soochow University

Suzhou, China

Zhongshan Hospital Xiamen University

Xiamen, China

And 68 more locations on ClinicalTrials.gov