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