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ACTIVE NOT RECRUITING
NCT06589986
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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

Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis

Key Details

Gender

All

Age Range

16 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2024-09-17

Completion Date

2031-01-30

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

DRUG

Placebo

Placebo matching IV afimkibart. Placebo matching SC afimkibart.

Locations (229)

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

Dothan, Alabama, United States

Arizona Digestive Health, P.C (ADH)

Sun City, Arizona, United States

Om Research LLC

Lancaster, California, United States

UCLA

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Stanford Medicine Outpatient Center

Redwood City, California, United States

Acclaim Clinical Research, Inc.

San Diego, California, United States

UCSF/Medical Center at Mount Zion

San Francisco, California, United States

Amicis Research Center

Santa Clarita, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Peak Gastroenterology Surgery Center

Lone Tree, Colorado, United States

Access Research Institute

Brooksville, Florida, United States

Gastro Florida

Clearwater, Florida, United States

HealthMed Clinical Center Inc.

Coral Gables, Florida, United States

J&A Clinical Research

Doral, Florida, United States

Clinical Research of Osceola, LLC

Kissimmee, Florida, United States

Auzmer Research

Lakeland, Florida, United States

Florida Research Institute - Lakewood

Lakewood Rch, Florida, United States

Homestead Associates in Research, Inc.

Miami, Florida, United States

Allied Biomedical Research Institute, Inc

Miami, Florida, United States

Miami Beach Clinical Research Center

Miami Beach, Florida, United States

Eminat Research Group

Miramar, Florida, United States

Orlando Regional Healthcare

Orlando, Florida, United States

Nodal Medical Center, LLC

Tampa, Florida, United States

Theia Clinical Research Centers, LLC

Tampa, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Florida Medical Clinic

Zephyrhills, Florida, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Next Innovative Clinical Research

Chicago, Illinois, United States

The University of Chicago

Chicago, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, United States

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, United States

Robley Rex VA Medical Center

Louisville, Kentucky, United States

Gastroenterology Health Partners, PLLC

Louisville, Kentucky, United States

Louisiana Research Center - GastroIntestinal Associates

Shreveport, Louisiana, United States

Brigham & Womens Hosp

Boston, Massachusetts, United States

Boston University

Boston, Massachusetts, United States

Michigan Center of Medical Research

Farmington Hills, Michigan, United States

Allied Gastrointestinal Associates, PA

Flowood, Mississippi, United States

BVL Clinical Research

Liberty, Missouri, United States

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, United States

Intercity Gastroenterology

Fresh Meadows, New York, United States

Northwell Health Physician Partners Gastroenterology at Great Neck

Great Neck, New York, United States

Pioneer Clinical Research NY

New York, New York, United States

Mainstreet - Richmond Hill Clinic

Richmond Hill, New York, United States

Digestive Health Partners, PA

Asheville, North Carolina, United States

Peters Medical Research (PMR), LLC

High Point, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Digestive Disease Consultants

Brunswick, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Gastroenterology Group

Columbus, Ohio, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Gastro Intestinal Research Institute of Northern Ohio

Westlake, Ohio, United States

University Gastroenterology

Providence, Rhode Island, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Gastro One

Cordova, Tennessee, United States

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, United States

Quality Medical Research

Nashville, Tennessee, United States

Texas Digestive Disease Consultants - Cedar Park

Cedar Park, Texas, United States

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Proactive El Paso,LLC

El Paso, Texas, United States

GI Alliance

Garland, Texas, United States

Baylor College of Medicine.

Houston, Texas, United States

TDDC dba GI Alliance Research

Mansfield, Texas, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

Digestive System Healthcare - Biopharma Informatic, LLC

Pasadena, Texas, United States

Carta - Clinical Associates In Research Therapeutics Of America;LLC

San Antonio, Texas, United States

Southern Star Research Institute, LLC.

San Antonio, Texas, United States

GI Alliance - Southlake

Southlake, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

University of Texas Health Center at Tyler

Tyler, Texas, United States

Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater

Chesapeake, Virginia, United States

Gastroenterology Consultants of SWVA

Roanoke, Virginia, United States

The Vancouver Clinic

Vancouver, Washington, United States

Marshall Health

Huntington, West Virginia, United States

Univ of Wisconsin Hosp & Clin

Madison, Wisconsin, United States

CIPREC Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, Argentina

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Lyell McEwin Hospital

Adelaide, South Australia, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medizinische Universität Innsbruck

Innsbruck, Austria

Barmherzige Brüder Wien

Vienna, Austria

Medizinische Universität Wien

Vienna, Austria

AZ Maria Middelares

Ghent, Belgium

CHC MontLégia

Liège, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

Centro Digestivo de Curitiba

Curitiba, Paraná, Brazil

Hospital de Clinicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, Brazil

MHAT St. Ivan Rilski

Gorna Oryahovitsa, Bulgaria

South Edmonton Gastroenterology

Edmonton, Alberta, Canada

Hospital Guillermo Grant Benavente

Concepción, Chile

Clinica Universidad de Los Andes

Santiago, Chile

Medwal

Santiago, Chile

Peking University Third Hospital

Beijing, China

Binzhou Medical university hospital

Binzhou, China

the First Hospital of Jilin University

Changchun, China

Sichuan Provincial People's Hospital

Chengdu, China

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The sixth affiliated hospital of Sun Yat-Sen University

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Huizhou First Hospital

Huizhou, China

Jinhua municipal central hospital

Jinhua, China

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, China

Nanjing 1st Hospital

Nanjing, China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Peking University Shenzhen Hospital

Shenzhen, China

Hebei Medical University - The Second Hospital

Shijiazhuang, China

Tianjin Medical University General Hospital

Tianjin, China

Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Ren Min Hospital Affiliated Wu Han University

Wuhan, China

Wuxi People's Hospital

Wuxi, China

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhuzhou Central Hospital

Zhuzhou, China

Borzan Polyclinic

Osijek, Croatia

SurGal Clinic s.r.o.

Brno, Czechia

Nemocnice Ceske Budejovice a.s.

České Budějovice, Czechia

Gastroenterologie s.r.o.

Hradec Králové, Czechia

Herlev Hospital

Herlev, Denmark

CHU Amiens - Hopital Sud

Amiens, France

CHU Dijon Bourgogne Hôpital François Mitterand

Dijon, France

CH Dptal Les Oudairies

La Roche-sur-Yon, France

CHRU de Lille - Hopital Claude Huriez

Lille, France

Hopital Nord

Marseille, France

Institut des MICI, Clinique Ambroise Paré

Neuilly-sur-Seine, France

CHU Nice - Hopital de l'Archet 2

Nice, France

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Hopital Robert Debre

Reims, France

CHU de Rennes - Hopital de Pontchaillo

Rennes, France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

Hôpital de Rangueil

Toulouse, France

Universitaetsklinikum Jena

Jena, Germany

Clinexpert Kft.

Budapest, Hungary

Obudai Egeszsegugyi Centrum Kft.

Budapest, Hungary

Pannonia Maganorvosi Centrum

Budapest, Hungary

Clinexpert Gyongyos Kft

Gyöngyös, Hungary

Clinfan Szolgaltato Kft.

Szekszárd, Hungary

Jávorszky Ödön Kórház

Vác, Hungary

Surat Institute of Digestive Sciences Hospitals

Surat, Gujarat, India

Gujarat Gastro and Vascular Hospital

Surat, Gujarat, India

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Shaare Zedek Medical Center

Jerusalem, Bayit Vegan, Israel

Ospedale Madonna delle Grazie

Matera, Basilicate, Italy

Universita'degli Studi di Napoli Federico II

Naples, Campania, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, Italy

ASST Rhodense - Ospedale di Rho

Rho, Lombardy, Italy

Tsujinaka Hospital Kashiwanoha

Chiba, Japan

Fukuoka University Hospital

Fukuoka, Japan

Hidaka Coloproctology Clinic

Fukuoka, Japan

Japanese Red Cross Takayama Hospital

Gifu, Japan

Aoyama Clinic;GI Endoscopy & IBD Center

Hyōgo, Japan

Kagawa Prefectural Central Hospital

Kagawa, Japan

Sameshima Hospital

Kagoshima, Japan

Gokeikai Ofuna Chuo Hospital

Kanagawa, Japan

Nagasaki University Hospital

Nagasaki, Japan

National Hospital Organization Osaka National Hospital

Osaka, Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, Japan

Saga-ken Medical Centre Koseikan

Saga, Japan

Saga University Hospital

Saga, Japan

National Hospital Organization Shizuoka Medical Center

Shizuoka, Japan

Matsuda Hospital

Shizuoka, Japan

Kitasato University Kitasato Institute Hospital

Tokyo, Japan

JCHO Tokyo Yamate Medical Center

Tokyo, Japan

Tokai University Hachioji Hospital

Tokyo, Japan

Yokohama City University Medical Center

Yokohama, Japan

Boca Clinical Trials Mexico S.C. (Guadalajara)

Guadalajara, Jalisco, Mexico

Accelerium S. de R.L. de C.V.

Monterrey, Nuevo León, Mexico

Hospital General de Mexico

Mexico, Tlaxcala, Mexico

Medical Care & Research SA de CV

Mérida, Yucatán, Mexico

SPZOZ w ??cznej

??czna, Poland

Clinical Trials UMED Sp. z o. o.

?ód?, Poland

Centrum Medyczne "Medis"

Bydgoszcz, Poland

Centrum Medyczne Lukamed Joanna Luka-Wendrowska

Chojnice, Poland

Endo-Med Sp. z o.o.

Karczew, Poland

Allmedica Badania Kliniczne Sp z o.o. Sp K.

Nowy Targ, Poland

Wojewodzki Specjalistyczny Szpital w Olsztynie

Olsztyn, Poland

NZOZ Eskulap Pabianice

Pabianice, Poland

SOLUMED Centrum Medyczne

Późna, Poland

Centrum Medyczne "MEDYK"

Rzeszów, Poland

Kiepury Clinic

Sosnowiec, Poland

Gastromed Sp. z o.o.

Toru?, Poland

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

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

Wroc?aw, Poland

Penta Hospitals Przychodnie, Wroclaw Wejherowska

Wroc?aw, Poland

Melita Medical

Wroclaw, Poland

ETG Zamosc

Zamo??, Poland

Hospital de Braga

Braga, Portugal

Hospital da Luz Lisboa

Lisbon, Portugal

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, Portugal

Hospital de Sao Joao

Porto, Portugal

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

Santa Maria da Feira, Portugal

Hospital Sao Teotonio

Viseu, Portugal

University of Puerto Rico - Medical Science Campus

San Juan, Puerto Rico

Colentina Clinical Hospital

Bucharest, Romania

Cantacuzino Clinical Hospital

Bucharest, Romania

University Hospital Center Dr Dragisa Misovic - Dedinje

Belgrade, Serbia

Clinical Hospital Center Zemun

Belgrade, Serbia

University Hospital Medical Center Bezanijska Kosa

Belgrade, Serbia

University Hospital Medical Center Zvezdara

Belgrade, Serbia

Clinical Center Kragujevac

Kragujevac, Serbia

Clinical Center of Vojvodina

Novi Sad, Serbia

Cliniq s.r.o.

Bratislava, Slovakia

Endomed, s.r.o.

Košice, Slovakia

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Changhua County, Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University

Bangkok, Thailand

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

Bangkok, Thailand

Liver Research Unit, Srinagarind Hospital

Khon Kaen, Thailand

Thammasat University Hospital

Pathum Thani, Thailand

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

Songkhla, Thailand

Surin hospital

Surin, Thailand

Addenbrookes Hospital

Cambridge, United Kingdom

Royal Liverpool University Hospital

Liverpool, United Kingdom

Guy's Hospital

London, United Kingdom