Recruiting

Phase 3

RO7790121A 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

Code:

NCT06819891

Conditions

Moderately to Severely Active Crohns Disease

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 (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).

Conditions

Moderately to Severely Active Crohns Disease

Study ID

NCT06819891

Start date

May 12, 2025

Status verified date

Aug, 2026

Completion date

Apr 30, 2033

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Confirmed diagnosis of CD
Moderately to severely active CD
Bodyweight >= 40 kilogram (kg)
Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
Diagnosis of short gut or short bowel syndrome
Presence of an ileostomy, colostomy or ileoanal pouch
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Presence of abdominal or perianal abscess
Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
Current diagnosis or suspicion of primary sclerosing cholangitis
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Any past or current evidence of cancer of gastrointestinal tract, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
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

425 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 afimkibart SC injection.

Interventions

Afimkibart

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

Placebo

Placebo matching IV afimkibart.

Primary outcome measure

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [ Time Frame: At Week 12 ]
Percentage of Participants with Endoscopic Response [ Time Frame: At Week 12 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GA45332 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

Recruiting

Dothan, Alabama, United States, 36305

Sun City Clinical Research

Recruiting

Glendale, Arizona, United States, 85304

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

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

Clinical Applications Laboratories, Inc.

Recruiting

San Diego, California, United States, 92103

Amicis Research Center

Recruiting

Santa Clarita, California, United States, 91355

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

J&A Clinical Research

Recruiting

Doral, Florida, United States, 33126

Auzmer Research

Recruiting

Lakeland, Florida, United States, 33813

Galenus Group Inc

Recruiting

Lehigh Acres, Florida, United States, 33936

Homestead Associates in Research, Inc.

Recruiting

Miami, Florida, United States, 33033

Allied Biomedical Research Institute, Inc

Recruiting

Miami, Florida, United States, 33155

Rejuvaline Medical Research

Recruiting

Miami, Florida, United States, 33155

Miami Beach Clinical Research Center

Recruiting

Miami Beach, Florida, United States, 33141

Eminat Research Group

Recruiting

Miramar, Florida, United States, 33027

Digestive and Liver Center of Florida

Recruiting

Orlando, Florida, United States, 32825

Advanced Medical Research Center

Recruiting

Port Orange, Florida, United States, 32127

Santos Research Center, CORP

Recruiting

Tampa, Florida, United States, 33615

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Morehouse School Of Medicine

Recruiting

Atlanta, Georgia, United States, 30310-1495

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Robley Rex VA Medical Center

Recruiting

Louisville, Kentucky, United States, 40206

One GI: GHP - Gastroenterology Health Partners Louisville

Recruiting

Louisville, Kentucky, United States, 40218

Baton Rouge General Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Louisiana Research Center - GastroIntestinal Associates

Recruiting

Shreveport, Louisiana, United States, 71105

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Chevy Chase Clinical Research

Recruiting

Chevy Chase, Maryland, United States, 20815

University of Massachusetts Memorial Medical Center

Recruiting

North Worcester, Massachusetts, United States, 01655

Gastroenterology Associates of Western Michigan, P.L.C.

Recruiting

Wyoming, Michigan, United States, 49519

Gastrointestinal Associates Research

Recruiting

Flowood, Mississippi, United States, 39232

Va Heartland Network - Harry S. Truman Memorial Veterans' Hospital

Recruiting

Columbia, Missouri, United States, 65201-5275

Specialists in Gastroenterology

Recruiting

St Louis, Missouri, United States, 63141

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Virtua Crohns and Colitis Center

Recruiting

Moorestown, New Jersey, United States, 08057

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Ellipsis Research Group

Recruiting

Brooklyn, New York, United States, 11215

Intercity Gastroenterology

Recruiting

Fresh Meadows, New York, United States, 11366

James J Peters Veterans Affairs Medical Center

Recruiting

The Bronx, New York, United States, 10468

Digestive Disease Medicine of Central New York

Recruiting

Utica, New York, United States, 13502

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

Recruiting

Charlotte, North Carolina, United States, 28207

Peters Medical Research (PMR), LLC

Recruiting

High Point, North Carolina, United States, 27260

Clinical Inquest Center

Recruiting

Beavercreek, Ohio, United States, 45431

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02904

Gastro One

Recruiting

Cordova, Tennessee, United States, 38018

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212-1375

University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center

Recruiting

Dallas, Texas, United States, 75390-8565

GI Alliance - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

GI Alliance

Recruiting

Garland, Texas, United States, 75044

Integrity Advanced Therapeutics PLLC

Recruiting

Houston, Texas, United States, 77090

Texas Digestive Disease Consultants-Lubbock powered by GI Alliance

Recruiting

Lubbock, Texas, United States, 79410

Carta - Clinical Associates In Research Therapeutics Of America;LLC

Recruiting

San Antonio, Texas, United States, 78212

University of Texas Health Center at Tyler

Recruiting

Tyler, Texas, United States, 75708

TDDC GI Alliance research Webster

Recruiting

Webster, Texas, United States, 77598

GI Alliance-Richmond

Recruiting

Richmond, Virginia, United States, 23229

University Physicians and Surgeons Inc, dba Marshall Health

Recruiting

Huntington, West Virginia, United States, 25701

Barrie GI Associates

Recruiting

Barrie, Ontario, Canada, L4M 7G1

GNRR Digestive Clinics and Research Center Inc.

Recruiting

Brampton, Ontario, Canada, L6S 0E2

LDDI Clinical Trials Inc.

Recruiting

London, Ontario, Canada, N6K 1M6

Toronto Immune and Digestive Health Institute

Recruiting

North YORK, Ontario, Canada, M6A 3B4

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-31.