Recruiting

Phase 3

RO7790121A 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

Code:

NCT06588855

Conditions

Moderately to Severely Active Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

Afimkibart

Placebo

Study Details

Brief 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).

Conditions

Moderately to Severely Active Ulcerative Colitis

Study ID

NCT06588855

Start date

Dec 11, 2024

Status verified date

Aug, 2026

Completion date

Jan 30, 2031

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Confirmed diagnosis of UC
Moderately to severely active UC assessed by mMS
Bodyweight >= 40 kilogram (kg)
Up to date with colorectal cancer (CRC) screening performed according to local standards
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
Presence of an ostomy or ileoanal pouch
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afimkibart

Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.

placebo comparator: Placebo

Participants will receive placebo IV followed by placebo SC.

Interventions

Afimkibart

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

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Primary outcome measure

Percentage of Participants with Clinical Remission [ Time Frame: At Week 12 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GA45330 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

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

Recruiting

Dothan, Alabama, United States, 36305

Mayo Clinic Hospital

Recruiting

Scottsdale, Arizona, United States, 85259

Arizona Digestive Health, P.C (ADH)

Recruiting

Sun City, Arizona, United States, 85351

Om Research LLC

Recruiting

Apple Valley, California, United States, 92307

Valley View Internal Medicine

Recruiting

Garden Grove, California, United States, 92845

Gastro Care Associates

Recruiting

Lancaster, California, United States, 93534

University of Southern California

Recruiting

Los Angeles, California, United States, 90033-1057

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education

Recruiting

Newport Beach, California, United States, 92663

Stanford Medicine Outpatient Center

Recruiting

Redwood City, California, United States, 94063

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Hi Tech and Global Research, LLC

Recruiting

Coral Gables, Florida, United States, 33134

The Sister Life Research

Recruiting

Hialeah, Florida, United States, 33013

LCC Medical Research Institute, LLC

Recruiting

Miami, Florida, United States, 33126

Allied Biomedical Research Institute

Recruiting

Miami, Florida, United States, 33155

Integrity Trials LLC

Recruiting

Orlando, Florida, United States, 32807

Digestive and Liver Center of Florida

Recruiting

Orlando, Florida, United States, 32825

Advanced Medical Research Center

Recruiting

Port Orange, Florida, United States, 32127

University of South Florida School of Medicine Morsani Center for Advanced Health Care

Recruiting

Tampa, Florida, United States, 33612

Guardian Angel Research Center, LLC

Recruiting

Tampa, Florida, United States, 33614

Santos Research Center, CORP

Recruiting

Tampa, Florida, United States, 33615

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Randomize Now, LLC

Recruiting

Atlanta, Georgia, United States, 30308

Atlanta Gastroenterology Associates

Recruiting

Atlanta, Georgia, United States, 30342

Gastroenterology Associates of Central Georgia

Recruiting

Macon, Georgia, United States, 31201

Grand Teton Research Group, PLLC

Recruiting

Idaho Falls, Idaho, United States, 83404

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Recruiting

Glenview, Illinois, United States, 60026

GI Alliance - Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Gastro Health Partners, LLC

Recruiting

New Albany, Indiana, United States, 47150

Kansas Gastroenterology, LLC under Clinical Trials Network

Recruiting

Wichita, Kansas, United States, 67226

One GI: GHP - Gastroenterology Health Partners Louisville

Recruiting

Louisville, Kentucky, United States, 40218

Louisiana Research Center - GastroIntestinal Associates

Recruiting

Shreveport, Louisiana, United States, 71105

Allied Gastrointestinal Associates, PA

Recruiting

Flowood, Mississippi, United States, 39232

Delta Gastroenterology & Endoscopy Center

Recruiting

Southaven, Mississippi, United States, 38671

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Ellipsis Research Group

Recruiting

Brooklyn, New York, United States, 11215

NYU Inflammatory Bowel Disease Center

Recruiting

New York, New York, United States, 10016

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

DiGiovanna Inst for Med Ed&Res

Recruiting

North Massapequa, New York, United States, 11758

Queens Village Medical Care

Recruiting

Queens Village, New York, United States, 11428

Gastroenterology Group Of Rochester, LLP

Recruiting

Rochester, New York, United States, 14618

James J Peters Veterans Administration Medical Center - NAVREF

Recruiting

The Bronx, New York, United States, 10468

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

Recruiting

Charlotte, North Carolina, United States, 28207

Omega Research North Carolina, LLC

Recruiting

Fuquay-Varina, North Carolina, United States, 27526

Peters Medical Research (PMR), LLC

Recruiting

High Point, North Carolina, United States, 27260

Dayton Gastroenterology, Inc.

Recruiting

Beavercreek, Ohio, United States, 45440

University of Cincinnati Hospital

Recruiting

Cincinnati, Ohio, United States, 45267

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Ohio Gastroenterology Group

Recruiting

Columbus, Ohio, United States, 43202

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Gastro Intestinal Research Institute of Northern Ohio

Recruiting

Westlake, Ohio, United States, 44145

Frontier Clinical Re search, LLC

Recruiting

Uniontown, Pennsylvania, United States, 15401

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02904

Gastroenterology Associates

Recruiting

Greenville, South Carolina, United States, 29607

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

Uni of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

GI Alliance

Recruiting

Garland, Texas, United States, 75044

Amel Med LLC

Recruiting

Georgetown, Texas, United States, 78628

Cano Medical Center

Recruiting

Harlingen, Texas, United States, 78550

Texas Digestive Specialists

Recruiting

Harlingen, Texas, United States, 78550

GI Alliance - Bay Area Gastroenterology

Recruiting

Lubbock, Texas, United States, 79410

TDDC dba GI Alliance Research

Recruiting

Mansfield, Texas, United States, 76063

Southern Star Research Institute, LLC.

Recruiting

San Antonio, Texas, United States, 78229

Baylor Scott and White Medical Center

Recruiting

Temple, Texas, United States, 76508

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

University of Texas Health Center at Tyler

Recruiting

Tyler, Texas, United States, 75708

TDDC GI Alliance research Webster

Recruiting

Webster, Texas, United States, 77598

Gastroenterology Associates of Tidewater

Recruiting

Chesapeake, Virginia, United States, 23320

Emeritas Research Group

Recruiting

Lansdowne Town Center, Virginia, United States, 20176

Gastroenterology Consultants of SWVA

Recruiting

Roanoke, Virginia, United States, 24018

Barrie GI Associates

Recruiting

Barrie, Ontario, Canada, L4M 7G1

London Health Sciences Centre Uni Campus

Recruiting

London, Ontario, Canada, N6A 5A5

LDDI Clinical Trials Inc.

Recruiting

London, Ontario, Canada, N6K 1M6

TIDHI Innovation Inc.

Recruiting

Toronto, Ontario, Canada, M6A 3B4

CIUSSS-de-l?Est-de-l?Île-de-Montréal

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-05.