Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
Summary
This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to \<18 years were enrolled, of which at least 30 were 6 years to \<12 years old. Subjects were enrolled at approximately 70 study sites worldwide.
Timeline
- Start
- 2015-09-29
- Primary completion
- 2018-12-13
- Completion
- 2023-03-30
Outcome
Met primary endpoint
registry analysis (superiority test); AIN457 Low Dose; p <.0001; Odds Ratio (OR) 25.78 (95% CI 7.08 to 114.66); Regression, Logistic NCT02471144 ↗
registry analysis (superiority test); AIN457 High Dose; p <.0001; Odds Ratio (OR) 22.65 (95% CI 6.31 to 98.93); Regression, Logistic NCT02471144 ↗
registry analysis (superiority test); AIN457 Low Dose; p <.0001; Odds Ratio (OR) 51.77 (95% CI 10.02 to 538.64); Regression, Logistic NCT02471144 ↗
registry analysis (superiority test); AIN457 High Dose; p <.0001; Odds Ratio (OR) 32.52 (95% CI 6.48 to 329.52); Regression, Logistic NCT02471144 ↗
Publications
- Sticherling M, Nikkels AF, Hamza AM, Kwong P, Szepietowski JC, El Sayed M, Ghislain PD, Khotko AA, Patekar M, Ortmann CE, Forrer P, Papanastasiou P, Keefe D. Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials. Am J Clin Dermatol. 2023 Sep;24(5):821-835. doi: 10.1007/s40257-023-00782-8. Epub 2023 Jun 21.
- Krasowska D, Gambichler T, Cortes C, Horev A, Compagno N, Dahale SS, Papanastasiou P, Keefe D. Long-term efficacy, safety and tolerability of secukinumab in children and adolescents with severe chronic plaque psoriasis: Two-year results from a Phase III double-blind, randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Mar 27. doi: 10.1111/jdv.19063. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 0.8 mg/kg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |