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
Status: Recruiting
Location: See all (299) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
RECRUITING
Dothan
Arizona
Sun City Clinical Research
RECRUITING
Glendale
Arizona Digestive Health, P.C (ADH)
RECRUITING
Sun City
University of Arizona-CATS Research Center
RECRUITING
Tucson
California
310 Clinical Research
RECRUITING
Inglewood
Om Research LLC
RECRUITING
Lancaster
University of California Irvine
RECRUITING
Orange
Acclaim Clinical Research, Inc.
RECRUITING
San Diego
UCSF/Medical Center at Mount Zion
RECRUITING
San Francisco
Amicis Research Center
RECRUITING
Santa Clarita
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Peak Gastroenterology Surgery Center
RECRUITING
Lone Tree
Florida
Access Research Institute
RECRUITING
Brooksville
Gastro Florida
RECRUITING
Clearwater
HealthMed Clinical Center Inc.
RECRUITING
Coral Gables
J&A Clinical Research
RECRUITING
Doral
Clinical Research of Osceola, LLC
RECRUITING
Kissimmee
Auzmer Research
RECRUITING
Lakeland
Florida Research Institute - Lakewood
RECRUITING
Lakewood Rch
Allied Biomedical Research Institute, Inc
RECRUITING
Miami
Homestead Associates in Research, Inc.
RECRUITING
Miami
Miami Beach Clinical Research Center
RECRUITING
Miami Beach
Eminat Research Group
RECRUITING
Miramar
Orlando Regional Healthcare
RECRUITING
Orlando
Nodal Medical Center, LLC
RECRUITING
Tampa
Theia Clinical Research Centers, LLC
RECRUITING
Tampa
Florida Medical Clinic
RECRUITING
Zephyrhills
Georgia
Gastroenterology Associates of Central Georgia
RECRUITING
Macon
Idaho
Grand Teton Research Group, PLLC
RECRUITING
Idaho Falls
Illinois
Next Innovative Clinical Research
RECRUITING
Chicago
The University of Chicago
RECRUITING
Chicago
Indiana
Indiana University Health University Hospital
RECRUITING
Indianapolis
Gastroenterology Health Partners, PLLC
RECRUITING
New Albany
Kentucky
Tri-State Gastroenterology Associates
RECRUITING
Crestview Hills
Gastroenterology Health Partners, PLLC
RECRUITING
Louisville
Robley Rex VA Medical Center
RECRUITING
Louisville
Louisiana
Louisiana Research Center - GastroIntestinal Associates
RECRUITING
Shreveport
Massachusetts
Boston University
RECRUITING
Boston
Brigham & Womens Hosp
RECRUITING
Boston
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Michigan
Michigan Center of Medical Research
RECRUITING
Farmington Hills
Missouri
BVL Clinical Research
RECRUITING
Liberty
Mississippi
Allied Gastrointestinal Associates, PA
RECRUITING
Flowood
Gastroenterology Associates and Endoscopy Center of North Mississippi
RECRUITING
Oxford
North Carolina
Digestive Health Partners, PA
RECRUITING
Asheville
Peters Medical Research (PMR), LLC
RECRUITING
High Point
Monroe Biomedical Research
RECRUITING
Monroe
Nevada
Las Vegas Clinical Trials, LLC
RECRUITING
North Las Vegas
New York
Intercity Gastroenterology
RECRUITING
Fresh Meadows
New York-Presbyterian Hospital-Columbia University Medical Center
RECRUITING
New York
Pioneer Clinical Research NY
RECRUITING
New York
Mainstreet - Richmond Hill Clinic
RECRUITING
Richmond Hill
Ohio
Digestive Disease Consultants
RECRUITING
Brunswick
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio Gastroenterology Group
RECRUITING
Columbus
Great Lakes Gastroenterology Research, LLC
RECRUITING
Mentor
Gastro Intestinal Research Institute of Northern Ohio
RECRUITING
Westlake
Oklahoma
Central Sooner Research
RECRUITING
Norman
Rhode Island
University Gastroenterology
RECRUITING
Providence
South Carolina
Medical University of South Carolina (MUSC)
RECRUITING
Charleston
Tennessee
Gastro One
RECRUITING
Cordova
Gastrointestinal Associates of Northeast Tennessee
RECRUITING
Johnson City
Quality Medical Research
RECRUITING
Nashville
Texas
Texas Clinical Research Institute, LLC
RECRUITING
Arlington
Texas Digestive Disease Consultants - Cedar Park
RECRUITING
Cedar Park
The University of Texas Southwestern Medical Center at Dallas
RECRUITING
Dallas
Proactive El Paso,LLC
RECRUITING
El Paso
GI Alliance
RECRUITING
Garland
Baylor College of Medicine.
RECRUITING
Houston
Integrity Advanced Therapeutics PLLC
RECRUITING
Houston
TDDC dba GI Alliance Research
RECRUITING
Mansfield
SMS Clinical Research, LLC
RECRUITING
Mesquite
Digestive System Healthcare - Biopharma Informatic, LLC
RECRUITING
Pasadena
Carta - Clinical Associates In Research Therapeutics Of America;LLC
RECRUITING
San Antonio
Southern Star Research Institute, LLC.
RECRUITING
San Antonio
GI Alliance - Southlake
RECRUITING
Southlake
Tyler Research Institute, LLC
RECRUITING
Tyler
University of Texas Health Center at Tyler
RECRUITING
Tyler
Virginia
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
RECRUITING
Chesapeake
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
RECRUITING
Roanoke
Washington
The Vancouver Clinic
RECRUITING
Vancouver
West Virginia
Marshall Health
RECRUITING
Huntington
Other Locations
Argentina
CIPREC Centro de Investigacion y Prevencion Cardiovascular
RECRUITING
Ciudad Autonoma Buenos Aires
Expertia S.A- Mautalen Salud e Investigación
RECRUITING
Ciudad Autonoma Buenos Aires
Australia
Flinders Medical Center
RECRUITING
Adelaide
Lyell McEwin Hospital
RECRUITING
Adelaide
Northern Hospital
RECRUITING
Epping
The Canberra Hospital
RECRUITING
Garran
Fiona Stanley Hospital
RECRUITING
Murdoch
Mater Misericordiae Limited
RECRUITING
South Brisbane
Royal Prince Alfred Hospital
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Barmherzige Brüder Wien
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
Cliniques Universitaires St-Luc
RECRUITING
Brussels
AZ Maria Middelares
RECRUITING
Ghent
CHC MontLégia
RECRUITING
Liège
CHU de Liège (Sart Tilman)
RECRUITING
Liège
AZ Delta (Campus Rumbeke)
RECRUITING
Roeselare
Vitaz
RECRUITING
Sint-niklaas
Brazil
Centro Digestivo de Curitiba
RECRUITING
Curitiba
Hospital de Clinicas de Porto Alegre X
RECRUITING
Porto Alegre
BR Trials - Pesquisa Clínica
RECRUITING
São Paulo
CPQuali Pesquisa Clinica Ltda
RECRUITING
São Paulo
Bulgaria
MHAT St. Ivan Rilski
RECRUITING
Gorna Oryahovitsa
MHAT Kaspela
RECRUITING
Plovdiv
Canada
South Edmonton Gastroenterology
RECRUITING
Edmonton
Queen Elizabeth II Health Sciences Centre
RECRUITING
Halifax
TDDA Specialty Research
RECRUITING
Woodbridge
Chile
Hospital Guillermo Grant Benavente
RECRUITING
Concepción
Clinica Universidad de Los Andes
RECRUITING
Santiago
Medwal
RECRUITING
Santiago
China
Peking University Third Hospital
RECRUITING
Beijing
Binzhou Medical university hospital
RECRUITING
Binzhou
the First Hospital of Jilin University
RECRUITING
Changchun
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
The Second Affiliated Hospital, Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital Of Fujian Medical University
RECRUITING
Fuzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The sixth affiliated hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huizhou First Hospital
RECRUITING
Huizhou
Jinhua municipal central hospital
RECRUITING
Jinhua
The 1st Affiliated Hospital of Nanchang Unversity
RECRUITING
Nanchang
Nanjing 1st Hospital
RECRUITING
Nanjing
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
Hebei Medical University - The Second Hospital
RECRUITING
Shijiazhuang
The First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Ren Min Hospital Affiliated Wu Han University
RECRUITING
Wuhan
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
The Second Affiliated Hospital of Xi'an Jiao Tong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Zhuzhou Central Hospital
RECRUITING
Zhuzhou
Croatia
Borzan Polyclinic
RECRUITING
Osijek
Denmark
Herlev Hospital
RECRUITING
Herlev
Sjaellands Universitetshospital, Køge
RECRUITING
Køge
France
CHU Amiens - Hopital Sud
RECRUITING
Amiens
CHU Dijon Bourgogne Hôpital François Mitterand
RECRUITING
Dijon
CH Dptal Les Oudairies
RECRUITING
La Roche-sur-yon
CHRU de Lille - Hopital Claude Huriez
RECRUITING
Lille
Hopital Nord
RECRUITING
Marseille
Institut des MICI, Clinique Ambroise Paré
RECRUITING
Neuilly-sur-seine
CHU Nice - Hopital de l'Archet 2
RECRUITING
Nice
CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITING
Pessac
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Hopital Robert Debre
RECRUITING
Reims
CHU de Rennes - Hopital de Pontchaillo
RECRUITING
Rennes
CHU Saint Etienne - Hôpital Nord
RECRUITING
Saint-etienne
Hôpital de Rangueil
RECRUITING
Toulouse
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
WITHDRAWN
Berlin
AGAPLESION Markus-Krankenhaus
WITHDRAWN
Frankfurt
Klinik Johann Wolfgang von Goethe Uni
WITHDRAWN
Frankfurt
Universitaetsklinikum Halle (Saale)
RECRUITING
Halle
Universitaetsklinikum Jena
RECRUITING
Jena
Klinikum Mannheim GmbH Universitätsklinikum
ACTIVE_NOT_RECRUITING
Mannheim
Universitätsklinikum Ulm
RECRUITING
Ulm
Hungary
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
RECRUITING
Békéscsaba
Clinexpert Kft.
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft.
RECRUITING
Budapest
Pannonia Maganorvosi Centrum
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Heves County Markhot Ferenc Teaching Hospital
RECRUITING
Eger
Clinexpert Gyongyos Kft
RECRUITING
Gyöngyös
Gyöngyösi Bugát Pál Kórház
WITHDRAWN
Gyöngyös
Clinfan Szolgaltato Kft.
RECRUITING
Szekszárd
Jávorszky Ödön Kórház
RECRUITING
Vác
India
SR Kalla Memorial Gastro & General Hospital
RECRUITING
Jaipur
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
Surat Institute of Digestive Sciences Hospitals
RECRUITING
Surat
Israel
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro
RECRUITING
Catanzaro
Ospedale Madonna delle Grazie
RECRUITING
Matera
Asst Santi Paolo E Carlo
RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Cagliari
RECRUITING
Monserrato
Universita'degli Studi di Napoli Federico II
RECRUITING
Napoli
Azienda Ospedaliera di Padova
RECRUITING
Padua
Fondazione IRCCS Policlinico San Matteo di Pavia
RECRUITING
Pavia
ASST Rhodense - Ospedale di Rho
RECRUITING
Rho
Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Rome
Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
I.R.C.C.S Policlinico San Donato
RECRUITING
San Donato Milanese (mi)
IRCCS Ospedale Casa Sollievo della Soffenza
RECRUITING
San Giovanni Rotondo
Ospedale Mauriziano Umberto I
RECRUITING
Turin
Japan
Nagoya City University Hospital
RECRUITING
Aichi
National Hospital Organization Hirosaki General Medical Center
RECRUITING
Aomori
Toho University Sakura Medical Center
RECRUITING
Chiba
Tsujinaka Hospital Kashiwanoha
RECRUITING
Chiba
Fukuoka University Chikushi Hospital
RECRUITING
Chikushino-shi
Fukuoka University Hospital
RECRUITING
Fukuoka
Hidaka Coloproctology Clinic
RECRUITING
Fukuoka
Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital
RECRUITING
Fukuoka
Kurume University Hospital
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center
RECRUITING
Fukuoka
St. Mary?s Hospital
RECRUITING
Fukuoka
Japanese Red Cross Takayama Hospital
RECRUITING
Gifu
Ogaki Municipal Hospital
RECRUITING
Gifu
Hiroshima University Hospital
RECRUITING
Hiroshima
Medical Corporation Sapporo IBD Clinic
RECRUITING
Hokkaido
Sapporo Kosei General Hospital
RECRUITING
Hokkaido
Sapporo Medical University Hospital
RECRUITING
Hokkaido
Aoyama Clinic;GI Endoscopy & IBD Center
RECRUITING
Hyōgo
Hyogo Medical University Hospital
RECRUITING
Hyōgo
Kagawa Prefectural Central Hospital
RECRUITING
Kagawa
Sameshima Hospital
RECRUITING
Kagoshima
Gokeikai Ofuna Chuo Hospital
RECRUITING
Kanagawa
Yokohama City University Medical Center
RECRUITING
Kanagawa
Nagasaki University Hospital
RECRUITING
Nagasaki
Ishida Clinic of IBD and Gastroenterology
RECRUITING
Ōita
Okayama University Hospital
RECRUITING
Okayama
Ome medical center
RECRUITING
Ome-shi
Kansai Medical University Hospital
RECRUITING
Osaka
Kinshukai Infusion Clinic
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Sai Gastroenterology/Proctology Clinic
RECRUITING
Osaka
Toyonaka Municipal Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
Saga-ken Medical Centre Koseikan
RECRUITING
Saga
Tokitokai Tokito Clinic
RECRUITING
Saitama
Matsuda Hospital
RECRUITING
Shizuoka
National Hospital Organization Shizuoka Medical Center
RECRUITING
Shizuoka
Institute of Science Tokyo Hospital
RECRUITING
Tokyo
JCHO Tokyo Yamate Medical Center
RECRUITING
Tokyo
Keio University Hospital
RECRUITING
Tokyo
Kitasato University Kitasato Institute Hospital
RECRUITING
Tokyo
NTT Medical Center Tokyo
RECRUITING
Tokyo
The Jikei University Hospital
RECRUITING
Tokyo
Tokai University Hachioji Hospital
RECRUITING
Tokyo
Yamagata University Hospital
RECRUITING
Yamagata
Mexico
Boca Clinical Trials Mexico S.C. (Guadalajara)
RECRUITING
Guadalajara
Medical Care & Research SA de CV
RECRUITING
Mérida
Hospital General de Mexico
RECRUITING
Mexico
Accelerium S. de R.L. de C.V.
RECRUITING
Monterrey
Netherlands
UMC St Radboud
RECRUITING
Nijmegen
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
SPZOZ w ??cznej
RECRUITING
??czna
Clinical Trials UMED Sp. z o. o.
RECRUITING
?ód?
Uniwersytecki Szpital Kliniczny W Bia?Ymstoku
RECRUITING
Bia?ystok
Centrum Medyczne Medis
RECRUITING
Bydgoszcz
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
RECRUITING
Chojnice
Endo-Med Sp. z o.o.
RECRUITING
Karczew
Allmedica Badania Kliniczne Sp z o.o. Sp K.
RECRUITING
Nowy Targ
Wojewodzki Specjalistyczny Szpital w Olsztynie
RECRUITING
Olsztyn
NZOZ Eskulap Pabianice
RECRUITING
Pabianice
Trialmed CRS
RECRUITING
Piotrkow Trybunalski
SOLUMED Centrum Medyczne
RECRUITING
Późna
Centrum Medyczne MEDYK
RECRUITING
Rzeszów
Kiepury Clinic
RECRUITING
Sosnowiec
Gastromed Sp. z o.o.
RECRUITING
Toru?
Centralny Szpital Kliniczny MSW w Warszawie
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Przychodnia EuroMediCare
RECRUITING
Wroc?aw
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
RECRUITING
Wroc?aw
Melita Medical
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamo??
Portugal
Hospital de Braga
RECRUITING
Braga
Hospital da Luz Lisboa
RECRUITING
Lisbon
Centro Hospitalar do Algarve - Hospital de Portimao
RECRUITING
Portimão
Hospital de Sao Joao
RECRUITING
Porto
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
RECRUITING
Santa Maria Da Feira
Hospital Sao Teotonio
RECRUITING
Viseu
Romania
Cantacuzino Clinical Hospital
RECRUITING
Bucharest
Colentina Clinical Hospital
RECRUITING
Bucharest
Serbia
Clinical Hospital Center Zemun
RECRUITING
Belgrade
University Hospital Center Dr Dragisa Misovic - Dedinje
RECRUITING
Belgrade
University Hospital Medical Center Bezanijska Kosa
RECRUITING
Belgrade
University Hospital Medical Center Zvezdara
RECRUITING
Belgrade
Clinical Center Kragujevac
RECRUITING
Kragujevac
Clinical Center of Vojvodina
RECRUITING
Novi Sad
Slovakia
ABAWI spol. s r.o.
RECRUITING
Bratislava
Cliniq s.r.o.
RECRUITING
Bratislava
Nemocnica Bory -Penta Hospitals
RECRUITING
Bratislava
Endomed, s.r.o.
RECRUITING
Košice
Nemocnica AGEL Kosice-Saca a.s.
RECRUITING
Košice
Ustredna vojenska nemocnica SNP Ruzomberok ? FN
RECRUITING
Ružomberok
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
RECRUITING
Changhua
E-Da Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Thailand
Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
RECRUITING
Bangkok
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
RECRUITING
Bangkok
Liver Research Unit, Srinagarind Hospital
RECRUITING
Khon Kaen
Thammasat University Hospital
RECRUITING
Pathum Thani
Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
RECRUITING
Songkhla
Surin hospital
RECRUITING
Surin
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
Russells Hall Hospital
RECRUITING
Dudley
St Mark's Hospital & Imperial College
RECRUITING
Harrow
Royal Liverpool University Hospital
RECRUITING
Liverpool
Guy's Hospital
RECRUITING
London
Queen Anne Street Medical Centre
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Reference Study ID Number: GA45329 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 400
Treatments
Experimental: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Placebo_comparator: Placebo
Participants will receive placebo IV followed by placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical