Back to Trials
NCT06588855PHASE3Recruiting

A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Hoffmann-La Roche

Start Date

12/11/2024

Completion Date

1/30/2031

Summary

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Eligibility Criteria

Age Range: 16 years to 80 years

Inclusion Criteria: * Confirmed diagnosis of UC * Moderately to severely active UC assessed by mMS * Bodyweight \>= 40 kilogram (kg) * Up to date with colorectal cancer (CRC) screening performed according to local standards * Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy * Males and females of childbearing potential must meet protocol criteria for contraception requirements Exclusion Criteria: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon) * Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis * Presence of an ostomy or ileoanal pouch * 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 or adenomas or neoplasia not completely removed * History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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) * 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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Moderately to Severely Active Ulcerative Colitis

Locations

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

Dothan, Alabama 36305

United States

Mayo Clinic Hospital

Scottsdale, Arizona 85259

United States

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona 85351

United States

Om Research LLC

Apple Valley, California 92307

United States

Valley View Internal Medicine

Garden Grove, California 92845

United States

Gastro Care Associates

Lancaster, California 93534

United States

University of Southern California

Los Angeles, California 90033-1057

United States

Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education

Newport Beach, California 92663

United States

Stanford Medicine Outpatient Center

Redwood City, California 94063

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Hi Tech and Global Research, LLC

Coral Gables, Florida 33134

United States

The Sister Life Research

Hialeah, Florida 33013

United States

LCC Medical Research Institute, LLC

Miami, Florida 33126

United States

Allied Biomedical Research Institute

Miami, Florida 33155

United States

Ambert Medical Research

Miami, Florida 33176

United States

Integrity Trials LLC

Orlando, Florida 32807

United States

Digestive and Liver Center of Florida

Orlando, Florida 32825

United States

Advanced Medical Research Center

Port Orange, Florida 32127

United States

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

Tampa, Florida 33612

United States

Guardian Angel Research Center, LLC

Tampa, Florida 33614

United States

Santos Research Center, CORP

Tampa, Florida 33615

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Randomize Now, LLC

Atlanta, Georgia 30308

United States

Atlanta Gastroenterology Associates

Atlanta, Georgia 30342

United States

Gastroenterology Associates of Central Georgia

Macon, Georgia 31201

United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho 83404

United States

Illinois Gastroenterology Group-Glenview powered by GI Alliance

Glenview, Illinois 60026

United States

GI Alliance - Gurnee

Gurnee, Illinois 60031

United States

Gastro Health Partners, LLC

New Albany, Indiana 47150

United States

Kansas Gastroenterology, LLC under Clinical Trials Network

Wichita, Kansas 67226

United States

One GI: GHP - Gastroenterology Health Partners Louisville

Louisville, Kentucky 40218

United States

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana 71105

United States

Allied Gastrointestinal Associates, PA

Flowood, Mississippi 39232

United States

Delta Gastroenterology & Endoscopy Center

Southaven, Mississippi 38671

United States

Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center

Lebanon, New Hampshire 03756

United States

Ellipsis Research Group

Brooklyn, New York 11215

United States

NYU Inflammatory Bowel Disease Center

New York, New York 10016

United States

Weill Cornell Medical College

New York, New York 10021

United States

DiGiovanna Inst for Med Ed&Res

North Massapequa, New York 11758

United States

Queens Village Medical Care

Queens Village, New York 11428

United States

Gastroenterology Group Of Rochester, LLP

Rochester, New York 14618

United States

James J Peters Veterans Administration Medical Center - NAVREF

The Bronx, New York 10468

United States

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

Charlotte, North Carolina 28207

United States

Omega Research North Carolina, LLC

Fuquay-Varina, North Carolina 27526

United States

Peters Medical Research (PMR), LLC

High Point, North Carolina 27260

United States

Dayton Gastroenterology, Inc.

Beavercreek, Ohio 45440

United States

University of Cincinnati Hospital

Cincinnati, Ohio 45267

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Ohio Gastroenterology Group

Columbus, Ohio 43202

United States

Ohio State University

Columbus, Ohio 43210

United States

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio 44145

United States

Frontier Clinical Re search, LLC

Uniontown, Pennsylvania 15401

United States

University Gastroenterology

Providence, Rhode Island 02904

United States

Gastroenterology Associates

Greenville, South Carolina 29607

United States

Gastro One

Cordova, Tennessee 38018

United States

Uni of Texas Medical Branch

Galveston, Texas 77555

United States

GI Alliance

Garland, Texas 75044

United States

Amel Med LLC

Georgetown, Texas 78628

United States

Cano Medical Center

Harlingen, Texas 78550

United States

Texas Digestive Specialists

Harlingen, Texas 78550

United States

Integrity Advanced Therapeutics PLLC

Houston, Texas 77090

United States

GI Alliance - Bay Area Gastroenterology

Lubbock, Texas 79410

United States

TDDC dba GI Alliance Research

Mansfield, Texas 76063

United States

Southern Star Research Institute, LLC.

San Antonio, Texas 78229

United States

Baylor Scott and White Medical Center

Temple, Texas 76508

United States

Tyler Research Institute, LLC

Tyler, Texas 75701

United States

University of Texas Health Center at Tyler

Tyler, Texas 75708

United States

TDDC GI Alliance research Webster

Webster, Texas 77598

United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia 23320

United States

Emeritas Research Group

Lansdowne Town Center, Virginia 20176

United States

Gastroenterology Consultants of SWVA

Roanoke, Virginia 24018

United States

Hospital Britanico

Ciudad Autonoma Bs As, C1280AEB

Argentina

Instituto Medico CER

Quilmes, B1878DVB

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

AZORG Campus Aalst-Moorselbaan

Aalst, 9300

Belgium

CHU St Pierre (St Pierre)

Brussels, 1000

Belgium

Cliniques Universitaires St-Luc

Brussels, 1200

Belgium

AZ Oostende

Ostend, 8400

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 Sírio-Libanês

São Paulo, São Paulo 01308-050

Brazil

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo 04266-010

Brazil

Second Multiprofile Hospital For Active Treatment-Sofia

Sofia Town, Sofia 1202

Bulgaria

MC " Sveti Ivan Rilski Chudotvorets- 2010

Plovdiv, 4003

Bulgaria

"City Clinic UMHAC" EOOD

Sofia, 1407

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

TIDHI Innovation Inc.

Toronto, Ontario M6A 3B4

Canada

CIUSSS-de-l?Est-de-l?Île-de-Montréal

Montreal, Quebec H1T 2M4

Canada

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034

Chile

Beijing No.6 Hospital

Beijing, Beijing Municipality 100007

China

The First Affilliated Hospital of Kunming Medical University

Kunming, Yunnan 650032

China

Third Xiangya Hospital Centrel South University

Changsha, 410013

China

West China Hospital of Sichuan University

Chengdu, 610041

China

Guangzhou First People's Hospital

Guangzhou, 510180

China

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260

China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016

China

Huizhou Central People's Hospital

Huizhou, 516001

China

The Second Affiliated Hospital of Nanchang University

Nanchang, 330008

China

The First Affiliate Hospital of Guangxi Medical University

Nanning, 530021

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315000

China

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266000

China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025

China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092

China

Shengjing Hospital of China Medical University

Shenyang, 110004

China

First Affiliated Hospital of Soochow University

Suzhou, 215006

China

The First Affiliated Hospital of Xiamen University

Xiamen, 361003

China

Zhongshan Hospital Xiamen University

Xiamen, 361004

China

Borzan Polyclinic

Osijek, 31000

Croatia

Clinical Hospital Center Sestre Milosrdnice

Zagreb, 10000

Croatia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, 500 12

Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, 708 52

Czechia

ISCARE a.s.

Prague, 170 04

Czechia

Ålborg Universitets Hospital

Aalborg, 9000

Denmark

CHU Tours - Hôpital Trousseau

Chambray-lès-Tours, 37170

France

CHU Clermont Ferrand - Hôtel Dieu

Clermont-Ferrand, 63000

France

Hôpital Henri Mondor

Créteil, 94000

France

Polyclinique Grand Sud

Nîmes, 30900

France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511

France

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, 21339

Germany

Klinikum Ernst von Bergmann

Potsdam, 14467

Germany

Észak-Pesti Centrumkórház-Honvédkórház

Budapest, 1062

Hungary

Semmelweis Egyetem

Budapest, 1082

Hungary

Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

Debrecen, 4025

Hungary

Fejer Varmegyei Szent György Egyetemi Oktatokorhaz

Székesfehérvár, 8000

Hungary

Vas-Oxy Egeszsegugyi Kft

Szombathely, 9700

Hungary

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat 395002

India

Gujarat Gastro and Vascular Hospital

Surat, Gujarat 395009

India

Kingsway Hospital

Nagpur (urban), Maharashtra 440001

India

MIDAS Multispeciality Hospital

Nagpur (urban), Maharashtra 440018

India

Sahyadri Super Speciality Hospital

Nashik, Maharashtra 422001

India

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan 302006

India

SMS Superspeciality Hospital

Jaipur, Rajasthan 302007

India

AIG Hospitals

Gachibowli, Telangana 500032

India

Yashoda Hospitals

Secunderabad, Telangana 500003

India

Soroka Medical Center

Beersheba, 8410101

Israel

The Chaim Sheba Medical Center

Ramat Gan, 5265601

Israel

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

Ospedale Isola Tiberina Gemelli

Rome, Lazio 00186

Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy 25123

Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy 20132

Italy

Azienda Ospedaliera San Gerardo di Monza

Monza MI, Lombardy 20900

Italy

Istituto Clinico Humanitas

Rozzano (MI), Lombardy 20089

Italy

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Veneto 37024

Italy

Boca Clinical Trials Mexico S.C. (Cd. Mexico)

Miguel Hidalgo, Mexico CITY (federal District) 01120

Mexico

FAICIC S de R.L. de C.V

Veracruz, 91900

Mexico

ETZ Elisabeth

Tilburg, 5022 GC

Netherlands

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.

?ód?, 93-357

Poland

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

Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska

Grudzadz, 86-300

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

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

Centrum Medyczne Oporow

Wroclaw, 52-416

Poland

Hospital de Braga

Braga, 4710-243

Portugal

Hospital da Luz Lisboa

Lisbon, 1500-650

Portugal

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, 8500-338

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

Klinical Investigations Group LLC

San Juan, 00909

Puerto Rico

General Hospital "Djordje Joanovic"

Zrenjanin, 23000

Serbia

KM Management spol. s r.o.

Nitra, 949 01

Slovakia

Accout Center s.r.o.

Šahy, 936 01

Slovakia

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid 28222

Spain

Hospital Clinico Univ. Lozano Blesa

Zaragoza, 50009

Spain

Hospital Universitario Miguel Servet

Zaragoza, 50009

Spain

China Medical University Hospital

Taichung, 40447

Taiwan

Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University

Chiang Mai, 50200

Thailand

Burapha University Hospital

Chon Buri, 20131

Thailand

Sunpasitthiprasong Hospital

Ubonratchathani, 34000

Thailand

Leicester General Hospital

Leicester, LE5 4PW

United Kingdom

Bronglais General Hospital

Llanrhystud, SY23 1ER

United Kingdom

King College Hospital NHS Foundation Trust

London, SE5 9RS

United Kingdom

Peterborough City Hospital

Peterborough, PE 3 9GZ

United Kingdom

Stepping Hill Hospital

Stockport, SK2 7JE

United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP

United Kingdom