Overview

Loss of RESponse to Ustekinumab Treated by Dose Escalation

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time
Phase:
Phase 3
Details
Lead Sponsor:
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborator:
Janssen Cilag N.V./S.A.
Treatments:
Ustekinumab