A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
Phase 3 – large-scale trial before approval
Conditions:
Moderately to Severely Active Crohns Disease
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 induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Who can participate
Inclusion Criteria:
* Confirmed diagnosis of CD
* Moderately to severely active CD
* Bodyweight \>= 40 kilogram (kg)
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
* Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
* Diagnosis of short gut or short bowel syndrome
* Presence of an ileostomy, colostomy or ileoanal pouch
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening
* 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
35
Argentina (1)
Hospital Britanico
Ciudad Autonoma Bs As
Australia (1)
The Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
AZORG Campus Aalst-Moorselbaan
Aalst
Brazil (1)
CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador , Estado de Bahia
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
Colombia (1)
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogota, D.C.
Croatia (1)
Borzan Polyclinic
Osijek
Czech Republic (1)
SurGal Clinic s.r.o.
Brno
Denmark (1)
Herlev Hospital
Herlev
Dominican Republic (1)
CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
Santo Domingo
France (1)
CHU Amiens - Hopital Sud
Amiens
Guatemala (1)
Celan S.A.
Guatemala City
Hungary (1)
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
Békéscsaba
India (1)
Shree Giriraj Multispeciality Hospital
Rajkot , Gujarat
Israel (1)
Soroka University Medical Centre
Beersheba , Negev
Italy (1)
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari , Apulia
Japan (1)
Asahikawa Medical University Hospital
Asahikawa-shi , Hokkaido
Mexico (1)
Boca Clinical Trials Mexico S.C. (Guadalajara)
Guadalajara , Jalisco
Netherlands (1)
Ziekenhuis Rijnstate
Arnhem
Panama (1)
Gastroenterólogos y Asociados
Panama City
Poland (1)
SPZOZ w ??cznej
??czna
Puerto Rico (1)
Klinical Investigations Group LLC
San Juan
Romania (1)
Cantacuzino Clinical Hospital
Bucharest
Serbia (1)
University Hospital Center Dr Dragisa Misovic - Dedinje
Belgrade
Slovakia (1)
Cliniq s.r.o.
Bratislava
South Korea (1)
Inje university Haeundae Paik Hospital
Busan
Spain (1)
Hospital Universitario Marques de Valdecilla
Santander , Cantabria
Taiwan (1)
National Taiwan University Hospital
Taipei , Zhongzheng District
Thailand (1)
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
Bangkok
United Arab Emirates (1)
Sheikh Shakhbout Medical City
Abu Dhabi
United Kingdom (1)
Addenbrookes Hospital
Cambridge
United States (1)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan