drugset / Trial / NCT03451851
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-07-11
- Primary completion
- 2023-07-19
- Completion
- 2026-12-18
Outcome
Met primary endpoint
registry Group 1 (Part 1): Placebo (Week 0-16) vs Group 2 (Part 1): Guselkumab (Week 0-16); p <0.001 NCT03451851 ↗
registry Difference in percentage 49.9 (95% CI 25.9 to 69.4) NCT03451851 ↗
registry Difference in percentage 55.6 (95% CI 32.1 to 74.0) NCT03451851 ↗
Publications
- Crauwels H, Ringold S, Howard S, Van Hartingsveldt B, Smith V, Jett M, Baguet T, Adamson E, Chakravarty SD, Leu JH. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. 2026 Jan;28(1):69-81. doi: 10.1007/s40272-025-00725-2. Epub 2025 Oct 28.
- Prajapati VH, Seyger MMB, Wilsmann-Theis D, Szakos E, Kaszuba A, van Hartingsveldt B, Jett M, Jiang G, Li S, Sinha V, Crauwels H, DeKlotz CMC, Paller AS. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | — |
| Subject | Guselkumab | Monoclonal antibody | — | Subcutaneous |