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
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 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).
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
27
Argentina (1)
Hospital Britanico
Ciudad Autonoma Bs As
Australia (1)
Macquarie University Hospital
Macquarie Park , New South Wales
Belgium (1)
AZORG Campus Aalst-Moorselbaan
Aalst
Brazil (1)
Instituto Lobus Unimed Volta Redonda
Volta Redonda , Rio de Janeiro
Bulgaria (1)
Second Multiprofile Hospital For Active Treatment-Sofia
Sofia Town , Sofia
WITHDRAWN
Canada (1)
Barrie GI Associates
Barrie , Ontario
Chile (1)
Centro de Investigación Clínica UC-CICUC
Santiago
China (1)
Beijing No.6 Hospital
Beijing , Beijing Municipality
Croatia (1)
Borzan Polyclinic
Osijek
Czech Republic (1)
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové
Denmark (1)
Ålborg Universitets Hospital
Aalborg
France (1)
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours
Hungary (1)
Észak-Pesti Centrumkórház-Honvédkórház
Budapest
WITHDRAWN
India (1)
Surat Institute of Digestive Sciences Hospitals
Surat , Gujarat
Israel (1)
Soroka Medical Center
Beersheba
Italy (1)
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna , Emilia-Romagna
Mexico (1)
Boca Clinical Trials Mexico S.C. (Cd. Mexico)
Miguel Hidalgo , Mexico CITY (federal District)
Netherlands (1)
ETZ Elisabeth
Tilburg
ACTIVE_NOT_RECRUITING
Poland (1)
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
?ód?
Puerto Rico (1)
Klinical Investigations Group LLC
San Juan
Serbia (1)
General Hospital "Djordje Joanovic"
Zrenjanin
Slovakia (1)
KM Management spol. s r.o.
Nitra
WITHDRAWN
Spain (1)
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
ACTIVE_NOT_RECRUITING
Taiwan (1)
China Medical University Hospital
Taichung
Thailand (1)
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
Chiang Mai
United Kingdom (1)
Leicester General Hospital
Leicester
United States (1)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan