USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)
Status:
Recruiting
Trial end date:
2023-09-02
Target enrollment:
Participant gender:
Summary
Phase IV
Trial design : Multicentre, randomized, double-blind, placebo-controlled study
Population : Moderate to severe Crohn's disease with at least one active perianal fistula
track
Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg)
followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo
SC The trial duration for each patient will be 48 weeks.
Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal
Crohn's disease.
Number of patients : A total of 146 patients will be included in 20 sites in France
Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient
last visit: Q3 2023
Phase:
Phase 4
Details
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives