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