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
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
Interventions
Afimkibart
Placebo
Conditions
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