A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 2/3 – combined trial
Conditions:
Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
trial.available_in:
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Overview
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
Who can participate
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
Locations
32
Argentina (1)
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Buenos Aires
Australia (1)
Emeritus Research
Camberwell
Belgium (1)
AZ Sint Lucas 1
Bruges
Brazil (1)
L2IP Instituto de Pesquisas Clinicas
Brasília
Bulgaria (1)
Medical Centre Asklepii OOD
Dupnitsa
Canada (1)
G I R I GI Research Institute Foundation
Vancouver , British Columbia
China (1)
Capital Medical University, Beijing Friendship Hospital
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