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
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Moderately to Severely Active Crohns Disease
Спонсор: Hoffmann-La Roche
Налично на:
БГ
Обобщение
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).
Кой може да участва
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
Места на провеждане
35
Argentina (1)
Hospital Britanico
Ciudad Autonoma Bs As
Австралия (1)
The Canberra Hospital
Garran , Australian Capital Territory
Белгия (1)
AZORG Campus Aalst-Moorselbaan
Aalst
Бразилия (1)
CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador , Estado de Bahia
България (1)
MHAT St. Ivan Rilski
Gorna Oryahovitsa
Канада (1)
South Edmonton Gastroenterology
Edmonton , Alberta
Chile (1)
Hospital Guillermo Grant Benavente
Concepción
Китай (1)
Peking University Third Hospital
Beijing
Colombia (1)
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogota, D.C.
Хърватия (1)
Borzan Polyclinic
Osijek
Чехия (1)
SurGal Clinic s.r.o.
Brno
Дания (1)
Herlev Hospital
Herlev
Dominican Republic (1)
CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
Santo Domingo
Франция (1)
CHU Amiens - Hopital Sud
Amiens
Guatemala (1)
Celan S.A.
Guatemala City
Унгария (1)
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
Békéscsaba
Индия (1)
Shree Giriraj Multispeciality Hospital
Rajkot , Gujarat
Израел (1)
Soroka University Medical Centre
Beersheba , Negev
Италия (1)
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari , Apulia
Япония (1)
Asahikawa Medical University Hospital
Asahikawa-shi , Hokkaido
Mexico (1)
Boca Clinical Trials Mexico S.C. (Guadalajara)
Guadalajara , Jalisco
Нидерландия (1)
Ziekenhuis Rijnstate
Arnhem
Panama (1)
Gastroenterólogos y Asociados
Panama City
Полша (1)
SPZOZ w ??cznej
??czna
Puerto Rico (1)
Klinical Investigations Group LLC
San Juan
Румъния (1)
Cantacuzino Clinical Hospital
Bucharest
Сърбия (1)
University Hospital Center Dr Dragisa Misovic - Dedinje
Belgrade
Словакия (1)
Cliniq s.r.o.
Bratislava
Южна Корея (1)
Inje university Haeundae Paik Hospital
Busan
Испания (1)
Hospital Universitario Marques de Valdecilla
Santander , Cantabria
Taiwan (1)
National Taiwan University Hospital
Taipei , Zhongzheng District
Тайланд (1)
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
Bangkok
United Arab Emirates (1)
Sheikh Shakhbout Medical City
Abu Dhabi
Великобритания (1)
Addenbrookes Hospital
Cambridge
САЩ (1)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan