USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) — USTAP  

Crohn's Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

• NCT number: NCT04496063
• Study type: Interventional
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Benjamin PARIENTE, MD PhD
• Phone: + 33 20 44 47 97
• Email: Benjamin.PARIENTE@CHRU-LILLE.FR
• Status: Recruiting
• Phase: Phase 4
• Start date: November 16, 2020
• Completion date: June 30, 2025