NCT04496063

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Main endpoint: The primary endpoint will be combined remission at week 12 defined as: * 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression) And * absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI Patient requiring UST optimization will be considered in failure but will be followed until week 48 Secondary endpoints: Definition * Clinical remission: 100% of the fistula tracts without any drainage by the external openings (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) * Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) * Radiological remission: absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI * Combined clinical and radiological remission at week 24 and 48. * Clinical remission (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) at week 12, 24 and 48 * Absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI at week 12, 24 and 48 * Evaluation of the magnetic resonance novel index for fistula imaging in CD at week 12, 24 and 48 * Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) at week 12, 24 and 48 * Combined clinical response and radiological remission at week 48 * Perineal Disease Activity Index (PDAI), Crohn Disease Activity Index (CDAI) at week 12, 24 and 48 * Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire (IBDQ) scores at week 24 and 48 * Correlation between response and remission and UST trough levels and antidrug (UST) antibodies at week 12, 24, 48 * Clinical response of UST optimization at week 48 (closure of at least 50% of all treated external openings that were draining at week 12) * Clinical response at week 48 of UST introduction at W12 (closure of at least 50% of all treated external

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Ustekinumab	Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
DRUG	Placebo	Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Timeline

• Start date: 2020-11-16
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2020-08-03
• Last updated: 2024-07-22

Locations

20 sites across 1 country: France