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NCT06819891PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

5/12/2025

Completion Date

4/30/2033

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

Age Range: 16 years to 80 years

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 * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * 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

Interventions

DRUG

Afimkibart

DRUG

Placebo

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Conditions

Moderately to Severely Active Crohns Disease

Locations

Sun City Clinical Research

Glendale, Arizona 85304

United States

Om Research LLC

Lancaster, California 93534

United States

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education

Newport Beach, California 92663

United States

Empire Clinical Research

Pomona, California 91767

United States

Stanford Medicine Outpatient Center

Redwood City, California 94063

United States

Clinical Applications Laboratories, Inc.

San Diego, California 92103

United States

Amicis Research Center

Santa Clarita, California 91355

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

J&A Clinical Research

Doral, Florida 33126

United States

Auzmer Research

Lakeland, Florida 33813

United States

Galenus Group Inc

Lehigh Acres, Florida 33936

United States

Homestead Associates in Research, Inc.

Miami, Florida 33033

United States

Allied Biomedical Research Institute, Inc

Miami, Florida 33155

United States

Rejuvaline Medical Research

Miami, Florida 33155

United States

Miami Beach Clinical Research Center

Miami Beach, Florida 33141

United States

Eminat Research Group

Miramar, Florida 33027

United States

Digestive and Liver Center of Florida

Orlando, Florida 32825

United States

Advanced Medical Research Center

Port Orange, Florida 32127

United States

Santos Research Center, CORP

Tampa, Florida 33615

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

The University of Chicago

Chicago, Illinois 60637

United States

Robley Rex VA Medical Center

Louisville, Kentucky 40206

United States

Baton Rouge General Medical Center

Baton Rouge, Louisiana 70809

United States

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana 71105

United States

Mercy Medical Center

Baltimore, Maryland 21202

United States

Chevy Chase Clinical Research

Chevy Chase, Maryland 20815

United States

University of Massachusetts Memorial Medical Center

North Worcester, Massachusetts 01655

United States

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

Wyoming, Michigan 49519

United States

Gastrointestinal Associates Research

Flowood, Mississippi 39232

United States

Harry S. Truman Memorial Veterans Hospital

Columbia, Missouri 65201-5275

United States

Virtua Crohns and Colitis Center

Moorestown, New Jersey 08057

United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States

Ellipsis Research Group

Brooklyn, New York 11215

United States

Intercity Gastroenterology

Fresh Meadows, New York 11366

United States

James J Peters Veterans Affairs Medical Center

The Bronx, New York 10468

United States

Digestive Disease Medicine of Central New York

Utica, New York 13502

United States

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

Charlotte, North Carolina 28207

United States

Peters Medical Research (PMR), LLC

High Point, North Carolina 27260

United States

Clinical Inquest Center

Beavercreek, Ohio 45431

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Gastro One

Cordova, Tennessee 38018

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37212-1375

United States

University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center

Dallas, Texas 75390-8565

United States

GI Alliance - Fort Worth

Fort Worth, Texas 76104

United States

GI Alliance

Garland, Texas 75044

United States

Integrity Advanced Therapeutics PLLC

Houston, Texas 77090

United States

Texas Digestive Disease Consultants-Lubbock powered by GI Alliance

Lubbock, Texas 79410

United States

Carta - Clinical Associates In Research Therapeutics Of America;LLC

San Antonio, Texas 78212

United States

University of Texas Health Center at Tyler

Tyler, Texas 75708

United States

TDDC GI Alliance research Webster

Webster, Texas 77598

United States

GI Alliance-Richmond

Richmond, Virginia 23229

United States

University Physicians and Surgeons Inc, dba Marshall Health

Huntington, West Virginia 25701

United States

Instituto Medico CER

Quilmes, B1878DVB

Argentina

CICE 9 de Julio

San Miguel de Tucumán, T4000DPK

Argentina

Macquarie University Hospital

Macquarie Park, New South Wales 2109

Australia

Coral Sea Clinical Research Institute

Mackay, Queensland 4740

Australia

Footscray Hospital

Footscray, Victoria 3011

Australia

Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010

Austria

Klinikum Wels-Grieskirchen

Wels, 4600

Austria

CHU St Pierre (St Pierre)

Brussels, 1000

Belgium

UZ Brussel

Brussels, 1090

Belgium

Cliniques Universitaires St-Luc

Brussels, 1200

Belgium

Instituto Lobus Unimed Volta Redonda

Volta Redonda, Rio de Janeiro 27258-000

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul 90035-000

Brazil

Newdata Clinical Trials

Aracaju, Sergipe 49055-000

Brazil

CECIP - Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo 17210-190

Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Hospital Sírio-Libanês

São Paulo, São Paulo 01308-050

Brazil

Multiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.

Panagyurishte, 4500

Bulgaria

MC " Sveti Ivan Rilski Chudotvorets- 2010

Plovdiv, 4003

Bulgaria

Barrie GI Associates

Barrie, Ontario L4M 7G1

Canada

GNRR Digestive Clinics and Research Center Inc.

Brampton, Ontario L6S 0E2

Canada

London Health Sciences Centre Uni Campus

London, Ontario N6A 5A5

Canada

LDDI Clinical Trials Inc.

London, Ontario N6K 1M6

Canada

Toronto Immune and Digestive Health Institute

North YORK, Ontario M6A 3B4

Canada

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Montreal, Quebec H1T 2M4

Canada

Medicina de Precisión - Celerity

Las Condes, 7560908

Chile

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034

Chile

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi 341000

China

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

Jinhua municipal central hospital

Jinhua, Zhejiang 321013

China

Beijing Union Hospital

Beijing, 100730

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

Guangzhou First People's Hospital

Guangzhou, 510180

China

Zhujiang Hospital, Southern Medical University

Guangzhou, 510280

China

Hainan General Hospital

Haikou, 570311

China

Huizhou First Hospital

Huizhou,

China

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008

China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092

China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200127

China

Shengjing Hospital of China Medical University

Shenyang, 110004

China

Hebei Medical University - The Second Hospital

Shijiazhuang, 050004

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, 710004

China

The First Affiliated Hospital of Xiamen University

Xiamen, 361003

China

Affiliated Hospital of Jiangsu University

Zhenjiang, 212001

China

Hospital Universitario San Ignacio

Bogotá, 000472

Colombia

Clínica de la Mujer

Bogotá, 110221

Colombia

Clinica Colsanitas S.A. - Sede Clinica Reina Sofia

Bogotá, 111071

Colombia

Oncomedica S.A.

Montería, 230002

Colombia

Borzan Polyclinic

Osijek, 31000

Croatia

Clinical Hospital Centre Zagreb

Zagreb, 10000

Croatia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52

Czechia

Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie

Prague, 140 21

Czechia

ISCARE a.s.

Prague, 170 04

Czechia

Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

Ústí nad Labem, 401 13

Czechia

Centre hospitalier Lyon Sud

Pierre-Bénite, Rhône 69310

France

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170

France

CHU Clermont Ferrand - Hôpital d'Estaing

Clermont-Ferrand, 63000

France

Hôpital Henri Mondor

Créteil, 94000

France

CH Dptal Les Oudairies

La Roche-sur-Yon, 85925

France

CHRU de Lille - Hopital Claude Huriez

Lille, 59037

France

Hopital Dupuytren

Limoges, 87042

France

Hopital Saint-Eloi

Montpellier, 34295

France

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, 92200

France

Hôpital Saint-Louis

Paris, 75475

France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511

France

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Klinikum Ernst von Bergmann

Potsdam, 14467

Germany

Észak-Pesti Centrumkórház-Honvédkórház

Budapest, 1062

Hungary

Geomedical Orvosi Kft

Budapest, 1066

Hungary

Semmelweis Egyetem

Budapest, 1082

Hungary

Endomedix Kft.

Budapest, 1139

Hungary

Vas-Oxy Egeszsegugyi Kft

Szombathely, 9700

Hungary

Kurnool Medical College

Kurnool, Andhra Pradesh 518002

India

Shree Giriraj Multispeciality Hospital

Rajkot, Gujarat 360005

India

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat 395002

India

Gujarat Gastro and Vascular Hospital

Surat, Gujarat 395009

India

Amrita Institute of Medical Sciences

Kochi, Kerala 682041

India

MIDAS Multispeciality Hospital

Nagpur (urban), Maharashtra 440018

India

All India Institute Of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi 110029

India

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan 302006

India

SMS Superspeciality Hospital

Jaipur, Rajasthan 302007

India

AIG Hospitals

Gachibowli, Telangana 500032

India

Gandhi Hospital

Secunderabad, Telangana 500003

India

Yashoda Hospitals

Secunderabad, Telangana 500003

India

Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital

Kolkata, West Bengal 700020

India

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah Medical Center

Jerusalem, 9112001

Israel

Ospedale Madonna delle Grazie

Matera, Basilicate 75100

Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti

Bologna, Emilia-Romagna 40138

Italy

Policlinico Universitario Campus Biomedico Di Roma

Rome, Lazio 00128

Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio 00168

Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy 25123

Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy 20132

Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardy 20097

Italy

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Veneto 37024

Italy

Gastromed Kralisz, Romatowski, Stachurska sp.j.

Bia?ystok, 15-322

Poland

Medical Center Kermed

Bydgoszcz, 85-231

Poland

Szpital Miejski sw. Jana Paw?a II w Elblagu

Elblag, 82-300

Poland

Osrodek Badan Klinicznych Bd Research

I?awa, 14-200

Poland

MZ Badania Slowik Zymla Sp.j.

Knurów, 44-190

Poland

Centrum Medyczne Promed

Krakow, 31-513

Poland

Amicare Sp. z o.o. S.K.

Lodz, 91-495

Poland

Medrise sp z o.o

Lublin, 20-582

Poland

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

Poznan, 61-731

Poland

EMC Instytut Medyczny SA

Późna, 60-309

Poland

Gabinety Lekarskie Rivermed

Późna, 61-441

Poland

Endoskopia Sp. z o.o.

Sopot, 81-756

Poland

Sonomed Sp. z o.o.

Szczecin, 71-685

Poland

Centrum Zdrowia-MDM

Warsaw, 00-189

Poland

Medon Clinical Research sp. z o.o

Warsaw, 02-679

Poland

Vivamed Spolka Z Ograniczona Odpowiedzialnoscia

Warsaw, 03-580

Poland

PlanetMed sp. z o.o.

Wroc?aw, 52-210

Poland

Hospital de Braga

Braga, 4710-243

Portugal

Hospital de Santa Maria

Lisbon, 1649-035

Portugal

Hospital de Sao Joao

Porto, 4202-451

Portugal

Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião

Santa Maria da Feira, 4520-211

Portugal

Hospital Sao Teotonio

Viseu, 3504-509

Portugal

Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive

Cluj-Napoca,

Romania

ABAWI spol. s r.o.

Bratislava, 821 07

Slovakia

KM Management spol. s r.o.

Nitra, 949 01

Slovakia

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do 15355

South Korea

Yeungnam University Medical Center

Daegu, 42415

South Korea

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, 03312

South Korea

Fundacion Hospital de Alcorcon

Alcorcón, Madrid 28922

Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid 28222

Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28040

Spain

Hospital Clinico Univ. Lozano Blesa

Zaragoza, 50009

Spain

Southmead Hospital

Bristol, BS10 5NB

United Kingdom

Fairfield General Hospital

Bury, BL9 7TD

United Kingdom

Bronglais General Hospital

Llanrhystud, SY23 1ER

United Kingdom

Royal London Hospital

London, E1 1FR

United Kingdom

Stepping Hill Hospital

Stockport, SK2 7JE

United Kingdom