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An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study

NCT05299931 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-02-05

No results posted yet for this study

Summary

The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the REScUE study (NCT04245215) because of secondary loss of response to a ustekinumab 90mg SC every 8 weeks (Q8w) regimen.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

dose escalation from every 8 weeks to every 4 weeks only in arm 2

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    collaborator INDUSTRY

  • Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    lead OTHER

Principal Investigators

  • Lieven Pouillon, MD · BIRD VZW

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT05299931 on ClinicalTrials.gov