Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

NCT04533737 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-03-14

Study results available
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Summary

The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.

Conditions

Interventions

BIOLOGICAL

Brodalumab

Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection

OTHER

Placebo

The placebo solution is similar to the active guselkumab (Dummy 1) or brodalumab (Dummy 2) solution except that it does not contain any active substance

BIOLOGICAL

Guselkumab

Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Medical Expert · LEO Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2022-09-08
Completion
2022-12-07
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT04533737 on ClinicalTrials.gov