Recruiting

Phase 3

RO7790121A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease

Sponsor:

Hoffmann-La Roche

Code:

NCT06819878

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 treat-through study will evaluate the efficacy and safety of induction and maintenance 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

NCT06819878

Start date

Mar 17, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 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
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, definite low-grade or high-grade colonic dysplasia
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

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Afimkibart

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

experimental: Arm 2: Afimkibart

Participants will receive afimkibart IV followed by afimkibart SC injection.

placebo comparator: Arm 3: Placebo

Participants will receive placebo IV followed by placebo SC.

Interventions

Afimkibart

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

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Primary outcome measure

Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [ Time Frame: At Week 52 ]
Percentage of Participants with Endoscopic Response [ Time Frame: At Week 52 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GA45331 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

Phoenix, Arizona, United States, 85054

Arizona Digestive Health, P.C (ADH)

Recruiting

Sun City, Arizona, United States, 85351

University of Arizona-CATS Research Center

Recruiting

Tucson, Arizona, United States, 85724

Valley View Internal Medicine

Recruiting

Garden Grove, California, United States, 92845-2006

310 Clinical Research

Recruiting

Inglewood, California, United States, 90301

UCSD Medical Center

Recruiting

La Jolla, California, United States, 92037-0897

Gastro Care Associates

Recruiting

Lancaster, California, United States, 93534

Om Research LLC

Recruiting

Lancaster, California, United States, 93534

United Gastroenterologists

Recruiting

Los Alamitos, California, United States, 90720

Acclaim Clinical Research, Inc.

Recruiting

San Diego, California, United States, 92120

Kaiser Permanente

Recruiting

San Francisco, California, United States, 94115

UCSF/Medical Center at Mount Zion

Recruiting

San Francisco, California, United States, 94115

Rocky Mountain Gastroenterology

Recruiting

Littleton, Colorado, United States, 80120

Peak Gastroenterology Surgery Center

Recruiting

Lone Tree, Colorado, United States, 80124

Access Research Institute

Recruiting

Brooksville, Florida, United States, 34613

Gastro Florida

Recruiting

Clearwater, Florida, United States, 33756

HealthMed Clinical Center Inc.

Recruiting

Coral Gables, Florida, United States, 33134

Hi Tech and Global Research, LLC

Recruiting

Coral Gables, Florida, United States, 33134

The Sister Life Research

Recruiting

Hialeah, Florida, United States, 33013

NeoClinical Research

Recruiting

Hialeah, Florida, United States, 33016

Clinical Research of Osceola, LLC

Recruiting

Kissimmee, Florida, United States, 34741

Florida Research Institute - Lakewood

Recruiting

Lakewood Rch, Florida, United States, 34211

LCC Medical Research Institute, LLC

Recruiting

Miami, Florida, United States, 33126

Orlando Regional Healthcare

Recruiting

Orlando, Florida, United States, 32806

Nodal Medical Center Research - NMC

Recruiting

Tampa, Florida, United States, 33607

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

Theia Clinical Research Centers, LLC

Recruiting

Temple Terrace, Florida, United States, 33617

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Florida Medical Clinic - Orlando Health

Recruiting

Zephyrhills, Florida, United States, 33542

Digestive Healthcare of Georgia

Recruiting

Atlanta, Georgia, United States, 30327

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

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Recruiting

Glenview, Illinois, United States, 60026

GI Alliance - Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Gastroenterology Health Partners, PLLC

Recruiting

New Albany, Indiana, United States, 47150

Kansas Gastroenterology, LLC under Clinical Trials Network

Recruiting

Wichita, Kansas, United States, 67226

Tri-State Gastroenterology Associates

Recruiting

Crestview Hills, Kentucky, United States, 41017-3409

Gastroenterology Health Partners, PLLC

Recruiting

Louisville, Kentucky, United States, 40218

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Boston University

Recruiting

Boston, Massachusetts, United States, 02118

Michigan Center of Medical Research

Recruiting

Farmington Hills, Michigan, United States, 48334

Gastroenterology Associates and Endoscopy Center of North Mississippi

Recruiting

Oxford, Mississippi, United States, 38655

Delta Gastroenterology & Endoscopy Center

Recruiting

Southaven, Mississippi, United States, 38671

Las Vegas Clinical Trials, LLC

Recruiting

North Las Vegas, Nevada, United States, 89030

Mount Sinai Hospital - IBD Clinical Center

Recruiting

New York, New York, United States, 10029

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

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

Mainstreet - Richmond Hill Clinic

Recruiting

Richmond Hill, New York, United States, 11418

Gastroenterology Group Of Rochester, LLP

Recruiting

Rochester, New York, United States, 14618

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Atrium Health, Carolinas Healthcare System

Recruiting

Charlotte, North Carolina, United States, 28204

Omega Research North Carolina, LLC

Recruiting

Fuquay-Varina, North Carolina, United States, 27526

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Dayton Gastroenterology, Inc.

Recruiting

Beavercreek, Ohio, United States, 45440

Digestive Disease Consultants

Recruiting

Brunswick, Ohio, United States, 44212

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

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Gastro Health- Liberty

Recruiting

Liberty Township, Ohio, United States, 45044

Gastro Intestinal Research Institute of Northern Ohio

Recruiting

Westlake, Ohio, United States, 44145

Central Sooner Research

Recruiting

Norman, Oklahoma, United States, 73071

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Frontier Clinical Re search, LLC

Recruiting

Uniontown, Pennsylvania, United States, 15401-9069

University Gastroenterology

Recruiting

Providence, Rhode Island, United States, 02904

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Gastroenterology Associates

Recruiting

Greenville, South Carolina, United States, 29607

Gastro One

Recruiting

Germantown, Tennessee, United States, 38138

Quality Medical Research

Recruiting

Nashville, Tennessee, United States, 37211

Texas Clinical Research Institute, LLC

Recruiting

Arlington, Texas, United States, 76012

Proactive El Paso,LLC

Recruiting

El Paso, Texas, United States, 79902

Amel Med LLC

Recruiting

Georgetown, Texas, United States, 78628

Cano Medical Center

Recruiting

Harlingen, Texas, United States, 78550

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

TDDC dba GI Alliance Research

Recruiting

Mansfield, Texas, United States, 76063

SMS Clinical Research, LLC

Recruiting

Mesquite, Texas, United States, 75149

Gastroenterology Research of America, LLC

Recruiting

San Antonio, Texas, United States, 78229

GI Alliance - Southlake

Recruiting

Southlake, Texas, United States, 76092

Baylor Scott and White Medical Center

Recruiting

Temple, Texas, United States, 76508

Tyler Research Institute, LLC

Recruiting

Tyler, Texas, United States, 75701

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

Recruiting

Chesapeake, Virginia, United States, 23320

Emeritas Research Group

Recruiting

Lansdowne Town Center, Virginia, United States, 20176

Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia

Recruiting

Lynchburg, Virginia, United States, 24502

Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

Recruiting

Roanoke, Virginia, United States, 24014

Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg

Recruiting

Williamsburg, Virginia, United States, 23188

The Vancouver Clinic

Recruiting

Vancouver, Washington, United States, 98664

South Edmonton Gastroenterology

Recruiting

Edmonton, Alberta, Canada, T6K 4B2

TDDA Specialty Research

Recruiting

Vaughan, Ontario, Canada, L4L 4Y7

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-20.