Overview

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

Status:
Recruiting

Trial end date:
2025-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Collaborator:

Janssen Cilag N.V./S.A.

Treatments:

Ustekinumab