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

Last updated: May 16, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RO7790121

Placebo

Clinical Study ID

NCT06819891
GA45332
2024-513054-30-00
  • Ages 16-80
  • All Genders

Study Summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction 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

  • Participants with symptomatic bowel strictures, fulminant colitis, or toxicmegacolon

  • 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: 425
Treatment Group(s): 2
Primary Treatment: RO7790121
Phase: 3
Study Start date:
May 12, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Macquarie University Hospital

    Macquarie Park, New South Wales 2109
    Australia

    Active - Recruiting

  • Coral Sea Clinical Research Institute

    Mackay, Queensland 4740
    Australia

    Active - Recruiting

  • London Health Sciences Centre Uni Campus

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Active - Recruiting

  • The First Affilliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Beijing Union Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, 510180
    China

    Active - Recruiting

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, 510280
    China

    Active - Recruiting

  • Huizhou First Hospital

    Huizhou,
    China

    Active - Recruiting

  • Jinhua municipal central hospital

    Jinhua,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang City, 330008
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    ShenYang, 110004
    China

    Active - Recruiting

  • Hebei Medical University - The Second Hospital

    Shijiazhuang City, 050004
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001
    China

    Active - Recruiting

  • Hospital Universitario San Ignacio

    Bogota, 000472
    Colombia

    Active - Recruiting

  • Oncomedica S.A.

    Monteria, 230002
    Colombia

    Active - Recruiting

  • CHU Clermont Ferrand - Hôtel Dieu

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • Hopital Dupuytren

    Limoges, 87042
    France

    Active - Recruiting

  • Hopital Saint-Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Pozna?, 61-731
    Poland

    Active - Recruiting

  • Centrum Zdrowia-MDM

    Warszawa, 00-189
    Poland

    Active - Recruiting

  • Royal London Hospital

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • J&A Clinical Research

    Doral, Florida 33173
    United States

    Active - Recruiting

  • Allied Biomedical Research Institute, Inc

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Eminat Research Group

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • Digestive and Liver Center of Florida

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Louisiana Research Center - GastroIntestinal Associates

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

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

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

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