Loss of RESponse to Ustekinumab Treated by Dose Escalation

  • STATUS
    Recruiting
  • End date
    Oct 1, 2022
  • participants needed
    108
  • sponsor
    Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Updated on 1 August 2021
ustekinumab
abdominal pain
crohn's disease
ulceration
ileitis
faecal calprotectin

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

Description

The study is a prospective double blind interventional study in patients with Crohn Disease treated with ustekinumab that show an objective secondary loss of response to ustekinumab after induction treatment (>Week 16). Patients can be screened during a four week period. The screening includes a clinical, biochemical and endoscopic assessment. Patients will be randomized 8 weeks after the last subcutaneous injection with ustekinumab. All patient will receive an intravenous re-induction with ustekinumab 6mg/kg at baseline (8 weeks after last subcutaneous administration). After the intravenous re-induction, the patients receive either ustekinumab 90 mg subcutaneous Q4W or Q8W (altered with q8w placebo to mimic Q4W injections) till week 48. Clinical and biochemical evaluation will be planned every 8 weeks until week36 with a final evaluation at week48. Primary endpoint will be assessed at week 48. Final assessment at week 48 will include clinical, biochemical and endoscopic evaluation.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment ustekinumab
Clinical Study IdentifierNCT04245215
SponsorBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Last Modified on1 August 2021

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