A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Фаза 2/3 – комбинирано изпитване
Заболявания:
Ulcerative Colitis
Спонсор: Janssen Research & Development, LLC
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Кой може да участва
Inclusion Criteria:
* Documented diagnosis of ulcerative colitis (UC)
* Moderately to severely active UC, defined by modified Mayo score
* Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
* Screening laboratory test results within the parameters specified in the protocol
Exclusion Criteria:
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
* UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Presence of a stoma
* Presence or history of a fistula
* Receiving prohibited medications and/or treatment
Места на провеждане
32
Argentina (1)
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires
Австралия (1)
Emeritus Research
Camberwell
Белгия (1)
AZ Sint Lucas 1
Bruges
Бразилия (1)
L2IP Instituto de Pesquisas Clinicas
Brasília
България (1)
Medical Centre Asklepii OOD
Dupnitsa
Канада (1)
G I R I GI Research Institute Foundation
Vancouver , British Columbia
Китай (1)
Capital Medical University, Beijing Friendship Hospital