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Loss of RESponse to Ustekinumab Treated by Dose Escalation

NCT04245215 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-04-13

Study results available
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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

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

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

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    collaborator INDUSTRY

  • Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    lead OTHER

Principal Investigators

  • Peter Bossuyt, MD · BIRD (Belgian IBD Research and Development) vzw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2024-09-25
Completion
2024-09-25

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245215 on ClinicalTrials.gov