Clinical Trial

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

Study acronym: USTAP
Unknown Phase 4
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Record status
This record was last updated July 22, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04496063
Lead Sponsor Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators: Janssen, LP
Conditions Crohn's Disease
Enrollment 33 participants
Start Date 2020-11-16
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-07-22