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USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

NCT04496063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-07-22

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Janssen, LP

    collaborator INDUSTRY

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496063 on ClinicalTrials.gov