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

Last updated: April 23, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RO7790121

Placebo

Clinical Study ID

NCT06819878
GA45331
2024-513053-69-00
  • Ages 16-80
  • All Genders

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).

Eligibility Criteria

Inclusion

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 leastone protocol-specified conventional or advanced CD therapy

  • Males and females of childbearing potential must meet protocol criteria forcontraception requirements

Exclusion

Exclusion Criteria:

  • Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemiccolitis, infectious colitis, radiation colitis, microscopic colitis

  • Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5following segments: terminal ilelium, right colon, transverse colon, sigmoid andleft 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 toxicmegacolon

  • Presence of abdominal or perianal abscess

  • Presence of rectovaginal 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

  • Past or current evidence of definite low-grade or high-grade colonic dysplasia oradenomas or neoplasia not completely removed

  • History of malignancy within 5 years, with the exception of malignancies adequatelytreated with resection for non-metastatic basal cell or squamous cell cancer or insitu cervical cancer

  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known asClostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV),Hepatitis B (HBV), Hepatitis C (HCV)

  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (perlocal guidance) or inadequately treated TB

  • Has received protocol-specified prohibited medicines, including known exposure toany type of anti-TL1A therapy

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: RO7790121
Phase: 3
Study Start date:
March 17, 2025
Estimated Completion Date:
December 31, 2033

Connect with a study center

  • Wuxi People's Hospital

    Wuxi, 214023
    China

    Active - Recruiting

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

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • Valley View Internal Medicine

    Garden Grove, California 92845-2006
    United States

    Active - Recruiting

  • Gastro Care Associates

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Peak Gastroenterology Surgery Center

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Access Research Institute

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Ambert Medical Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Guardian Angel Research Center, LLC

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • Nodal Medical Center Research - NMC

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Theia Clinical Research Centers, LLC

    Temple Terrace, Florida 33617-1666
    United States

    Active - Recruiting

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Digestive Healthcare of Georgia

    Atlanta, Georgia 30327
    United States

    Active - Recruiting

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Illinois Gastroenterology Group-Glenview powered by GI Alliance

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • GI Alliance - Gurnee

    Gurnee, Illinois 60031
    United States

    Active - Recruiting

  • Gastro Health Partners, LLC

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Kansas Gastroenterology, LLC under Clinical Trials Network

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Tri-State Gastroenterology Associates

    Crestview Hills, Kentucky 41017-3409
    United States

    Active - Recruiting

  • Gastroenterology Health Partners, PLLC

    Louisville, Kentucky 40218
    United States

    Active - Recruiting

  • Gastroenterology Associates and Endoscopy Center of North Mississippi

    Oxford, Mississippi 38655
    United States

    Active - Recruiting

  • Delta Gastroenterology & Endoscopy Center

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York 11758
    United States

    Active - Recruiting

  • Gastroenterology Group of Rochester under CTNx

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Dayton Gastroenterology, Inc.

    Beavercreek, Ohio 45440
    United States

    Active - Recruiting

  • Ohio Gastroenterology Group

    Columbus, Ohio 43202
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Active - Recruiting

  • University Gastroenterology

    Providence, Rhode Island 02904
    United States

    Active - Recruiting

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Texas Clinical Research Institute, LLC

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Amel Med LLC

    Georgetown, Texas 78628
    United States

    Active - Recruiting

  • Cano Medical Center

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • TDDC dba GI Alliance Research

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Gastroenterology Research of America, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • GI Alliance - Southlake

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Active - Recruiting

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

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

  • Emeritas Research Group

    Lansdowne Town Center, Virginia 20176
    United States

    Active - Recruiting

  • Gastroenterology Consultants and Endoscopy Center of Southwest Virginia

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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