A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Status: Recruiting
Location: See all (151) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
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
Arizona
Mayo Clinic Hospital
RECRUITING
Scottsdale
California
Om Research LLC
RECRUITING
Apple Valley
Valley View Internal Medicine
RECRUITING
Garden Grove
Gastro Care Associates
RECRUITING
Lancaster
Florida
Hi Tech and Global Research, LLC
RECRUITING
Coral Gables
The Sister Life Research
RECRUITING
Hialeah
Ambert Medical Research
RECRUITING
Miami
LCC Medical Research Institute, LLC
RECRUITING
Miami
Digestive and Liver Center of Florida
RECRUITING
Orlando
Gastroenterology Institute of Orlando
RECRUITING
Orlando
Advanced Medical Research Center
RECRUITING
Port Orange
Guardian Angel Research Center, LLC
RECRUITING
Tampa
Santos Research Center, CORP
RECRUITING
Tampa
University of South Florida School of Medicine Morsani Center for Advanced Health Care
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Associates
RECRUITING
Atlanta
Illinois
Illinois Gastroenterology Group-Glenview powered by GI Alliance
RECRUITING
Glenview
GI Alliance - Gurnee
RECRUITING
Gurnee
Indiana
Gastro Health Partners, LLC
RECRUITING
New Albany
Kansas
Kansas Gastroenterology, LLC under Clinical Trials Network
RECRUITING
Wichita
Kentucky
One GI: GHP - Gastroenterology Health Partners Louisville
RECRUITING
Louisville
Mississippi
Delta Gastroenterology & Endoscopy Center
RECRUITING
Southaven
North Carolina
Charlotte Gastroenterology and Hepatology, P.L.L.C
RECRUITING
Charlotte
Omega Research North Carolina, LLC
RECRUITING
Fuquay-varina
New York
Ellipsis Research Group
RECRUITING
Brooklyn
DiGiovanna Inst for Med Ed&Res
RECRUITING
North Massapequa
Queens Village Medical Care
RECRUITING
Queens Village
Gastroenterology Group of Rochester under CTNx
RECRUITING
Rochester
Ohio
Dayton Gastroenterology, Inc.
RECRUITING
Beavercreek
University of Cincinnati Hospital
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University
RECRUITING
Hilliard
Pennsylvania
Frontier Clinical Re search, LLC
RECRUITING
Uniontown
South Carolina
Gastroenterology Associates, PA PA of Greenville
RECRUITING
Greenville
Texas
Amel Med LLC
RECRUITING
Georgetown
Cano Medical Center
RECRUITING
Harlingen
Texas Digestive Specialists
RECRUITING
Harlingen
Baylor Scott and White Medical Center
RECRUITING
Temple
Virginia
Emeritas Research Group
RECRUITING
Lansdowne Town Center
Other Locations
Argentina
Hospital Britanico
RECRUITING
Ciudad Autonoma Bs As
Instituto Medico CER
RECRUITING
Quilmes
Australia
Footscray Hospital
RECRUITING
Footscray
Coral Sea Clinical Research Institute
RECRUITING
Mackay
Macquarie University Hospital
RECRUITING
Macquarie Park
Royal Melbourne Hospital
RECRUITING
Parkville
Austria
Ordensklinikum Linz Barmherzige Schwestern
RECRUITING
Linz
Klinikum Wels-Grieskirchen
RECRUITING
Wels
Belgium
AZORG Campus Aalst-Moorselbaan
RECRUITING
Aalst
CHU St Pierre (St Pierre)
RECRUITING
Brussels
Cliniques Universitaires St-Luc
RECRUITING
Brussels
AZ Oostende
RECRUITING
Ostend
Brazil
Newdata Clinical Trials
RECRUITING
Aracaju
CECIP - Centro de Estudos Clínicos do Interior Paulista
RECRUITING
Jaú
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Centro Paulista de Investigacao Clinica - CEPIC
RECRUITING
São Paulo
Instituto Lobus Unimed Volta Redonda
RECRUITING
Volta Redonda
Bulgaria
MC Sveti Ivan Rilski Chudotvorets- 2010
RECRUITING
Plovdiv
City Clinic UMHAC EOOD
RECRUITING
Sofia
Second Multiprofile Hospital For Active Treatment-Sofia
RECRUITING
Sofia Town
Canada
Barrie GI Associates
RECRUITING
Barrie
London Health Sciences Centre Uni Campus
RECRUITING
London
CIUSSS-de-l?Est-de-l?Île-de-Montréal
RECRUITING
Montreal
TIDHI Innovation Inc.
RECRUITING
Toronto
Chile
Centro de Investigación Clínica UC-CICUC
RECRUITING
Santiago
China
Beijing No.6 Hospital
RECRUITING
Beijing
Third Xiangya Hospital Centrel South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Guangzhou First People's Hospital
RECRUITING
Guangzhou
The second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University
RECRUITING
Hangzhou
Huizhou Central People's Hospital
RECRUITING
Huizhou
The First Affilliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliate Hospital of Guangxi Medical University
RECRUITING
Nanning
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
The Affiliated Hospital of Medical College Qingdao University
RECRUITING
Qingdao
Ruijin Hospital Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
Croatia
Borzan Polyclinic
RECRUITING
Osijek
Denmark
Ålborg Universitets Hospital
RECRUITING
Aalborg
France
CHU Tours - Hôpital Trousseau
RECRUITING
Chambray-lès-tours
CHU Clermont Ferrand - Hôtel Dieu
RECRUITING
Clermont-ferrand
Hôpital Henri Mondor
RECRUITING
Créteil
Polyclinique Grand Sud
RECRUITING
Nîmes
Hôpital de Brabois Adultes
RECRUITING
Vandœuvre-lès-nancy
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Medizinisches Zentrum Klinikum Lueneburg
RECRUITING
Lüneburg
Klinikum Ernst von Bergmann
RECRUITING
Potsdam
Hungary
Észak-Pesti Centrumkórház-Honvédkórház
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
RECRUITING
Debrecen
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
RECRUITING
Székesfehérvár
Vas-Oxy Egeszsegugyi Kft
RECRUITING
Szombathely
India
SR Kalla Memorial Gastro & General Hospital
RECRUITING
Jaipur
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
Israel
Soroka Medical Center
RECRUITING
Beersheba
Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
RECRUITING
Bologna
Asst Degli Spedali Civili Di Brescia
RECRUITING
Brescia
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera San Gerardo di Monza
RECRUITING
Monza Mi
IRCCS Ospedale Sacro Cuore Don Calabria
RECRUITING
Negrar
Ospedale Isola Tiberina Gemelli
RECRUITING
Rome
Policlinico Universitario Campus Biomedico Di Roma
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano (mi)
Mexico
Boca Clinical Trials Mexico S.C. (Cd. Mexico)
RECRUITING
Miguel Hidalgo
FAICIC S de R.L. de C.V
RECRUITING
Veracruz
Netherlands
ETZ Elisabeth
RECRUITING
Tilburg
Poland
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
RECRUITING
?ód?
Gastromed Kralisz, Romatowski, Stachurska sp.j.
RECRUITING
Bia?ystok
Medical Center Kermed
RECRUITING
Bydgoszcz
Szpital Miejski sw. Jana Paw?a II w Elblagu
RECRUITING
Elblag
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
WITHDRAWN
Grudzadz
Osrodek Badan Klinicznych Bd Research
RECRUITING
I?awa
MZ Badania Slowik Zymla Sp.j.
RECRUITING
Knurów
Centrum Medyczne Promed
RECRUITING
Krakow
Medrise sp z o.o
RECRUITING
Lublin
EMC Instytut Medyczny SA
RECRUITING
Późna
Gabinety Lekarskie Rivermed
RECRUITING
Późna
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
RECRUITING
Poznan
Endoskopia Sp. z o.o.
RECRUITING
Sopot
Sonomed Sp. z o.o.
RECRUITING
Szczecin
Centrum Zdrowia-MDM
RECRUITING
Warsaw
Medon Clinical Research sp. z o.o
RECRUITING
Warsaw
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
RECRUITING
Warsaw
PlanetMed sp. z o.o.
RECRUITING
Wroc?aw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
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
Puerto Rico
Klinical Investigations Group LLC
RECRUITING
San Juan
Serbia
General Hospital Djordje Joanovic
RECRUITING
Zrenjanin
Slovakia
Accout Center s.r.o.
RECRUITING
Šahy
Spain
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Clinico Univ. Lozano Blesa
RECRUITING
Zaragoza
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Thailand
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
RECRUITING
Chiang Mai
Burapha University Hospital
RECRUITING
Chon Buri
Sunpasitthiprasong Hospital
RECRUITING
Ubonratchathani
United Kingdom
Leicester General Hospital
RECRUITING
Leicester
Bronglais General Hospital
RECRUITING
Llanrhystud
King College Hospital NHS Foundation Trust
RECRUITING
London
Peterborough City Hospital
RECRUITING
Peterborough
Stepping Hill Hospital
RECRUITING
Stockport
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Reference Study ID Number: GA45330 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2024-12-11
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 350
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