2. Subcutaneous ustekinumab every 4 weeks for Crohn's Disease (REScUE Trial)

Phase 3

Waitlist Available

Led By Peter Bossuyt, MD

Research Sponsored by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Pivotal Trial

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

Eligible Conditions

Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with steroid free clinical remission and fecal calprotectin<250µg/g at week 48

Secondary study objectives

Proportion of patients with at all time points after baseline ustekinumab trough concentration > 1.4 μg/mL

Proportion of patients with biomarker remission at week 48

Proportion of patients with clinical remission at week 48

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 2. Subcutaneous ustekinumab every 4 weeksActive Control1 Intervention

re-induction (≈6mg/kg) intravenous ustekinumab followed by 90 mg Subcutaneous ustekinumab every 4 weeks (Q4W) for 48 weeks

Group II: 1. Subcutaneous ustekinumab every 8 weeksPlacebo Group1 Intervention

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

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