A 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

Last updated: July 14, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

RO7790121

Placebo

Afimkibart

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 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

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

Connect with a study center

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB
    Argentina

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • Mater Misericordiae Limited

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Barmherzige Brüder Wien

    Wien, 1020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Active - Recruiting

  • AZORG Campus Aalst-Moorselbaan

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Active - Recruiting

  • AZ Sint Lucas (Sint Lucas)

    Gent, 9000
    Belgium

    Active - Recruiting

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • CHC MontLégia

    Liege, 4000
    Belgium

    Active - Recruiting

  • CHU de Liège (Sart Tilman)

    Liège, 4000
    Belgium

    Active - Recruiting

  • CHU HELORA - Hôpital de Mons - Site Kennedy

    Mons, 7000
    Belgium

    Active - Recruiting

  • Vitaz

    Sint Niklaas, 9100
    Belgium

    Active - Recruiting

  • South Edmonton Gastroenterology

    Edmonton, Alberta T6K 4B2
    Canada

    Active - Recruiting

  • C.I.C. Mauricie

    Trois-rivieres, Quebec G8T 7A1
    Canada

    Active - Recruiting

  • Hospital Guillermo Grant Benavente

    Concepcion, 4030000
    Chile

    Active - Recruiting

  • Clinica Universidad de Los Andes

    Santiago, DUMMY_VALUE
    Chile

    Active - Recruiting

  • Medwal

    Santiago, 7500000
    Chile

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Third Xiangya Hospital Centrel South University

    Changsha, 410013
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu City, 610041
    China

    Active - Recruiting

  • Chongqing General Hospital

    Chongqing City, 401147
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou City, 350005
    China

    Active - Recruiting

  • The second Affiliated Hospital of Guangzhou Medical University

    Guangzhou City, 510260
    China

    Active - Recruiting

  • The sixth affiliated hospital of Sun Yat-Sen University

    Guangzhou City, 510655
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou City, 310016
    China

    Active - Recruiting

  • Zhejiang Province Traditional Chinese Medical Hospital

    Hangzhou City, 310006
    China

    Active - Recruiting

  • Anhui Provincial Hospital

    Hefei, 230001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

    Active - Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001
    China

    Active - Recruiting

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang City, 330006
    China

    Active - Recruiting

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo City, 315000
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai City, 200126
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, 518036
    China

    Active - Recruiting

  • Taizhou Hospital Of Zhejiang Province

    Taizhou City, 318050
    China

    Active - Recruiting

  • Ren Min Hospital Affiliated Wu Han University

    Wuhan, 430060
    China

    Active - Recruiting

  • The Central Hospital of Wuhan

    Wuhan City, 430014
    China

    Active - Recruiting

  • Wuxi People's Hospital

    Wuxi, 214023
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, DUMMY_VALUE
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, 412007
    China

    Active - Recruiting

  • SurGal Clinic s.r.o.

    Brno, 602 00
    Czechia

    Active - Recruiting

  • Gastroenterologie s.r.o.

    Hradec Kralove, 500 02
    Czechia

    Active - Recruiting

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

  • CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)

    Santo Domingo, 10134
    Dominican Republic

    Active - Recruiting

  • CHU Amiens - Hopital Sud

    Amiens, 80054
    France

    Active - Recruiting

  • Hopital Nord

    Marseille, 13015
    France

    Active - Recruiting

  • CHU Nice - Hopital de l'Archet 2

    Nice, 06202
    France

    Active - Recruiting

  • Hopital Robert Debre

    Reims, 51092
    France

    Active - Recruiting

  • CHU de Rennes - Hopital de Pontchaillo

    Rennes, 35033
    France

    Active - Recruiting

  • CHU Saint Etienne - Hôpital Nord

    Saint Etienne, 42055
    France

    Active - Recruiting

  • Charite - Campus Benjamin Franklin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt, 60590
    Germany

    Active - Recruiting

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Jena

    Jena, 77430
    Germany

    Active - Recruiting

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036
    Hungary

    Active - Recruiting

  • Pannonia Maganorvosi Centrum

    Budapest, 1136
    Hungary

    Active - Recruiting

  • Clinexpert Gyongyos Kft

    Gyongyos, 3200
    Hungary

    Active - Recruiting

  • Clinfan Szolgaltato Kft.

    Szekszard, 7100
    Hungary

    Active - Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Ospedale Isola Tiberina Gemelli

    Roma, Lazio 00186
    Italy

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Chiba, 277-0871
    Japan

    Active - Recruiting

  • Boca Clinical Trials Mexico S.C. (Guadalajara)

    Guadalajara, Jalisco 44600
    Mexico

    Active - Recruiting

  • Medical Care & Research SA de CV

    Mérida, Yucatan 97000
    Mexico

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-229
    Poland

    Active - Recruiting

  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600
    Poland

    Active - Recruiting

  • Endo-Med Sp. z o.o.

    Karczew, DUMMY_VALUE
    Poland

    Active - Recruiting

  • SOLUMED Centrum Medyczne

    Pozna?, 60-529
    Poland

    Active - Recruiting

  • Gastromed Sp. z o.o.

    Toru?, 87-100
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny MSW w Warszawie

    Warszawa, 02-507
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Active - Recruiting

  • Przychodnia EuroMediCare

    Wroc?aw, 50-220
    Poland

    Active - Recruiting

  • Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?

    Wroc?aw, 53-149
    Poland

    Active - Recruiting

  • ETG Zamosc

    Zamosc, 22-400
    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

  • Klinical Investigations Group LLC

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Murcia, 30003
    Spain

    Active - Recruiting

  • China Medical University Hospital

    Taichung City, 40447
    Taiwan

    Active - Recruiting

  • Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni

    Bangkok, 10700
    Thailand

    Active - Recruiting

  • Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University

    Songkhla, 90110
    Thailand

    Active - Recruiting

  • King College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Queen Anne Street Medical Centre

    London, W1T 6AH
    United Kingdom

    Active - Recruiting

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

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • Arizona Digestive Health, P.C (ADH)

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Valley View Internal Medicine

    Garden Grove, California 92845-2006
    United States

    Active - Recruiting

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Active - Recruiting

  • Gastro Care Associates

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • United Gastroenterologists

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Acclaim Clinical Research, Inc.

    San Diego, California 92120
    United States

    Active - Recruiting

  • UCSF/Medical Center at Mount Zion

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology

    Littleton, Colorado 80120
    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

  • Gastro Florida

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • NeoClinical Research

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • The Sister Life Research

    Hialeah, Florida 33013
    United States

    Active - Recruiting

  • Clinical Research of Osceola, LLC

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Florida Research Institute - Lakewood

    Lakewood Ranch, Florida 34211
    United States

    Active - Recruiting

  • Ambert Medical Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • LCC Medical Research Institute, LLC

    Miami, Florida 33126
    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

  • University of South Florida School of Medicine Morsani Center for Advanced Health Care

    Tampa, Florida 33612
    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

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Michigan Center of Medical Research

    Farmington Hills, Michigan 48334
    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

  • Las Vegas Clinical Trials, LLC

    North Las Vegas, Nevada 89030
    United States

    Active - Recruiting

  • DiGiovanna Inst for Med Ed&Res

    North Massapequa, New York 11758
    United States

    Active - Recruiting

  • Queens Village Medical Care

    Queens Village, New York 11428
    United States

    Active - Recruiting

  • Gastroenterology Group of Rochester under CTNx

    Rochester, New York 14618
    United States

    Active - Recruiting

  • Omega Research North Carolina, LLC

    Fuquay-Varina, North Carolina 27526
    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

  • Frontier Clinical Re search, LLC

    Uniontown, Pennsylvania 15401-9069
    United States

    Active - Recruiting

  • University Gastroenterology

    Providence, Rhode Island 02904
    United States

    Active - Recruiting

  • Gastroenterology Associates, PA PA of Greenville

    Greenville, South Carolina 29607
    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

  • The Vancouver Clinic

    Vancouver, Washington 98664
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.