A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
NCT03451851 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-05-08
Summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
Conditions
Interventions
- DRUG
-
Guselkumab
Participants will receive a weight-based dose of guselkumab subcutaneously.
- DRUG
-
Placebo for guselkumab
Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
- DRUG
-
Etanercept
Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-11
- Primary Completion
- 2023-07-19
- Completion
- 2026-12-18
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Germany
- Hungary
- Italy
- Netherlands
- Poland
Study Locations
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