Loss of RESponse to Ustekinumab Treated by Dose Escalation

Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Study ID
NCT04245215
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    re-induction and dose escalation form every 8 weeks to every 4 weeks only in arm 2

Study Details

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

Key Dates

Start date
Mar 11, 2020
Status verified
Mar 2026
Primary completion
Sep 25, 2024
Completion
Sep 25, 2024

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 1. Subcutaneous ustekinumab every 8 weeks
    re-induction (≈6mg/kg) intravenous ustekinumab followed by 90 mg Subcutaneous ustekinumab every 8 weeks (Q8W) for 48 weeks - receiving Q8W placebo to mimic Q4W injections
  • Active Comparator: 2. Subcutaneous ustekinumab every 4 weeks
    re-induction (≈6mg/kg) intravenous ustekinumab followed by 90 mg Subcutaneous ustekinumab every 4 weeks (Q4W) for 48 weeks

Primary Outcome Measure

Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48 [ Time Frame: week 48 ]

Related Studies