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Набира участници Фаза 3 NCT06819891

A Study to Assess the Efficacy and Safety of Induction 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 study will evaluate the efficacy and safety of induction 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 * Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * 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 23
Argentina (1)
Instituto Medico CER
Quilmes
Австралия (1)
Macquarie University Hospital
Macquarie Park , New South Wales
Белгия (1)
CHU St Pierre (St Pierre)
Brussels
Бразилия (1)
Instituto Lobus Unimed Volta Redonda
Volta Redonda , Rio de Janeiro
България (1)
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv
Канада (1)
Barrie GI Associates
Barrie , Ontario
Chile (1)
Medicina de Precisión - Celerity
Las Condes
Китай (1)
First Affiliated Hospital of Gannan Medical University
Ganzhou , Jiangxi
Colombia (1)
Hospital Universitario San Ignacio
Bogotá
Хърватия (1)
Borzan Polyclinic
Osijek
Чехия (1)
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové
Франция (1)
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours
Германия (1)
Universitätsklinikum Heidelberg
Heidelberg
Унгария (1)
Észak-Pesti Centrumkórház-Honvédkórház
Budapest
Индия (1)
Shree Giriraj Multispeciality Hospital
Rajkot , Gujarat
Израел (1)
Shaare Zedek Medical Center
Jerusalem
Италия (1)
Ospedale Madonna delle Grazie
Matera , Basilicate
Полша (1)
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok
Румъния (1)
Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
Cluj-Napoca
Словакия (1)
ABAWI spol. s r.o.
Bratislava
Испания (1)
Fundacion Hospital de Alcorcon
Alcorcón , Madrid
Великобритания (1)
Fairfield General Hospital
Bury
САЩ (1)
Sun City Clinical Research
Glendale , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
12.05.2025
Крайна дата
30.04.2033
Регистрационен номер
NCT06819891
Източник
anzctr
Запитване за медицински туризъм

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