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

Last updated: July 15, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RO7790121

Afimkibart

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 Afimkibart (also known as 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, enterovaginal, high output enterocutaneous fistula,enterovesical 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

  • Any past or current evidence of cancer of gastrointestinal tract, definite low-gradeor high-grade colonic dysplasia

  • History of non-gastrointestinal cancer, with the exception of adequately treatednon-metastatic basal cell or squamous cell skin cancer or in situ 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) during screening

  • 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): 3
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

  • Klinikum Wels-Grieskirchen

    Wels, 4600
    Austria

    Active - Recruiting

  • UZ Brussel

    Brussel, 1090
    Belgium

    Active - Recruiting

  • CHU St Pierre (St Pierre)

    Brussels, 1000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Barrie GI Associates

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • London Health Sciences Centre Uni Campus

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Toronto Immune and Digestive Health Institute

    North York, Ontario M6A 3B4
    Canada

    Active - Recruiting

  • Centro de Investigación Clínica UC-CICUC

    Santiago, 8330034
    Chile

    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

  • Jinhua municipal central hospital

    Jinhua, Zhejiang 321013
    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

  • Hainan General Hospital

    Haikou, 570311
    China

    Active - Recruiting

  • Huizhou First Hospital

    Huizhou,
    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

  • The Second Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an City, 710004
    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

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Kralove, 500 12
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52
    Czechia

    Active - Recruiting

  • ISCARE a.s.

    Praha 7, 170 04
    Czechia

    Active - Recruiting

  • CHU Tours - Hôpital Trousseau

    Chambray les Tours, 37170
    France

    Active - Recruiting

  • CHU Clermont Ferrand - Hôpital d'Estaing

    Clermont Ferrand, 63000
    France

    Active - Recruiting

  • CHU Clermont Ferrand - Hôtel Dieu

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Active - Recruiting

  • CH Dptal Les Oudairies

    La Roche Sur Yon, 85925
    France

    Active - Recruiting

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • Hopital Dupuytren

    Limoges, 87042
    France

    Active - Recruiting

  • Hopital Saint-Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • Institut des MICI, Clinique Ambroise Paré

    Neuilly sur Seine, 92200
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75475
    France

    Active - Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • Hôpital de Brabois Adultes

    Vandoeuvre-les-nancy, 54511
    France

    Active - Recruiting

  • Vas-Oxy Egeszsegugyi Kft

    Szombathely, 9700
    Hungary

    Active - Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, Lazio 00168
    Italy

    Active - Recruiting

  • Policlinico Universitario Campus Biomedico Di Roma

    Roma, Lazio 00128
    Italy

    Active - Recruiting

  • Medical Center Kermed

    Bydgoszcz, 85-231
    Poland

    Active - Recruiting

  • MZ Badania Slowik Zymla Sp.j.

    Knurów, 44-190
    Poland

    Active - Recruiting

  • Centrum Medyczne Promed

    Kraków, 31-513
    Poland

    Active - Recruiting

  • Medrise sp z o.o

    Lublin, 20-582
    Poland

    Active - Recruiting

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

    Pozna?, 61-731
    Poland

    Active - Recruiting

  • Gabinety Lekarskie Rivermed

    Pozna?, 61-441
    Poland

    Active - Recruiting

  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Centrum Zdrowia-MDM

    Warszawa, 00-189
    Poland

    Active - Recruiting

  • PlanetMed sp. z o.o.

    Wroc?aw, 52-210
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • Hospital de Sao Joao

    Porto, 4202-451
    Portugal

    Active - Recruiting

  • Hospital Clinico Univ. Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Fairfield General Hospital

    Bury, BL9 7TD
    United Kingdom

    Active - Recruiting

  • Bronglais General Hospital

    Llanrhystud, SY23 1ER
    United Kingdom

    Active - Recruiting

  • Royal London Hospital

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Amicis Research Center

    Santa Clarita, California 91355
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    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

  • Homestead Associates in Research, Inc.

    Miami, Florida 33033
    United States

    Active - Recruiting

  • Miami Beach Clinical Research Center

    Miami Beach, Florida 33141
    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

  • Mercy Medical Center

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

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

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • Intercity Gastroenterology

    Fresh Meadows, New York 11366
    United States

    Active - Recruiting

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

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • Clinical Inquest Center

    Beavercreek, Ohio 45431
    United States

    Active - Recruiting

  • GI Alliance

    Garland, Texas 75044
    United States

    Active - Recruiting

  • Carta - Clinical Associates In Research Therapeutics Of America;LLC

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • University of Texas Health Center at Tyler

    Tyler, Texas 75708
    United States

    Active - Recruiting

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