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
Phase 3 – large-scale trial before approval
Conditions:
Moderately to Severely Active Ulcerative Colitis
Sponsor: Hoffmann-La Roche
trial.available_in:
БГ
Overview
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).
Who can participate
Inclusion Criteria:
* 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
Exclusion Criteria:
* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Locations
28
Argentina (1)
CIPREC Centro de Investigacion y Prevencion Cardiovascular
Ciudad Autonoma Buenos Aires
Australia (1)
The Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
AZ Maria Middelares
Ghent
Brazil (1)
Centro Digestivo de Curitiba
Curitiba , Paraná
Bulgaria (1)
MHAT St. Ivan Rilski
Gorna Oryahovitsa
Canada (1)
South Edmonton Gastroenterology
Edmonton , Alberta
Chile (1)
Hospital Guillermo Grant Benavente
Concepción
China (1)
Peking University Third Hospital
Beijing
Croatia (1)
Borzan Polyclinic
Osijek
Czech Republic (1)
SurGal Clinic s.r.o.
Brno
Denmark (1)
Herlev Hospital
Herlev
France (1)
CHU Amiens - Hopital Sud
Amiens
Hungary (1)
Clinexpert Kft.
Budapest
India (1)
Surat Institute of Digestive Sciences Hospitals
Surat , Gujarat
Israel (1)
Shaare Zedek Medical Center
Jerusalem , Bayit Vegan
Italy (1)
Ospedale Madonna delle Grazie
Matera , Basilicate
Japan (1)
Tsujinaka Hospital Kashiwanoha
Chiba
Mexico (1)
Boca Clinical Trials Mexico S.C. (Guadalajara)
Guadalajara , Jalisco
Poland (1)
SPZOZ w ??cznej
??czna
Puerto Rico (1)
University of Puerto Rico - Medical Science Campus
San Juan
Romania (1)
Colentina Clinical Hospital
Bucharest
Serbia (1)
University Hospital Center Dr Dragisa Misovic - Dedinje
Belgrade
Slovakia (1)
Cliniq s.r.o.
Bratislava
Spain (1)
Hospital Universitario Marques de Valdecilla
Santander , Cantabria
Taiwan (1)
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua , Changhua County
Thailand (1)
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
Bangkok
United Kingdom (1)
Addenbrookes Hospital
Cambridge
United States (1)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan