A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Colitis, Ulcerative
Спонсор: Janssen Research & Development, LLC
Налично на:
БГ
Обобщение
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).
Кой може да участва
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
Места на провеждане
25
Argentina (1)
Cer Instituto Medico
Buenos Aires
Австралия (1)
Royal Adelaide Hospital
Adelaide
Белгия (1)
Onze -Lieve-Vrouwziekenhuis
Aalst
Бразилия (1)
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu
България (1)
Medical centre Asklepion
Sofia
Канада (1)
Fraser Clinical Trials Inc.
New Westminster , British Columbia
Китай (1)
China Japan Friendship Hospital
Beijing
Чехия (1)
Nemocnice Ceske Budejovice a s
České Budějovice
Франция (1)
CHRU Besancon Hopital Jean Minjoz
Besançon
Германия (1)
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau
Унгария (1)
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
Индия (1)
Fortis Memorial Research Institute
Gurugram
Израел (1)
Ha'Emek Medical Center
Afula
Япония (1)
Tokyo Medical and Dental University Hospital
Bunkyō City
Jordan (1)
The Speciality Hospital (TSH) / Advanced Clinical Center
БГ
EN