A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 3 – large-scale trial before approval
Conditions:
Colitis, Ulcerative
Sponsor: Janssen Research & Development, LLC
trial.available_in:
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Overview
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Who can participate
Inclusion Criteria:
* Signed informed consent form
* 18 years of age or older
* Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
* Moderately to severely active UC as per the modified Mayo score
* Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
Exclusion Criteria:
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
* Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
* Receiving prohibited medications and treatments
* UC limited to the rectum only
* Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
Locations
25
Argentina (1)
Cer Instituto Medico
Buenos Aires
Australia (1)
Royal Adelaide Hospital
Adelaide
Belgium (1)
Onze -Lieve-Vrouwziekenhuis
Aalst
Brazil (1)
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu
Bulgaria (1)
Medical centre Asklepion
Sofia
Canada (1)
Fraser Clinical Trials Inc.
New Westminster , British Columbia
China (1)
China Japan Friendship Hospital
Beijing
Czech Republic (1)
Nemocnice Ceske Budejovice a s
České Budějovice
France (1)
CHRU Besancon Hopital Jean Minjoz
Besançon
Germany (1)
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau
Hungary (1)
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
India (1)
Fortis Memorial Research Institute
Gurugram
Israel (1)
Ha'Emek Medical Center
Afula
Japan (1)
Tokyo Medical and Dental University Hospital
Bunkyō City
Jordan (1)
The Speciality Hospital (TSH) / Advanced Clinical Center
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