USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT04496063
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
  • Placebo — DRUG
    Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Study Details

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

Key Dates

Start date
Nov 16, 2020
Status verified
Jul 2024
Primary completion
Jun 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 Ustekinumab
    Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
  • Placebo Comparator: Group 2 Placebo
    Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Primary Outcome Measure

Combined clinical and radiological remission [ Time Frame: Week 12 ]

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