Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

Summary

This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity.

Timeline

Start

2018-08-29

Primary completion

2019-09-19

Completion

2023-09-12

Outcome

Met primary endpoint

registry analysis (superiority test); AIN457 Low Dose; Predicted Log-OR 4.862 (95% CI 3.422 to 6.782); Bayesian method using (MAP) NCT03668613 ↗

registry analysis (superiority test); AIN457 Low Dose; Predicted log -OR 4.292 (95% CI 2.638 to 6.513); Bayesian method using (MAP) NCT03668613 ↗

Publications

• Kingo K, Papanastasiou P, Beissert S, Lazareva S, Villa AV, Bartonova J, Ballona R, Bansal A, Martin R, Fan H, O'Doherty C, Ravichandran S, Magnolo N. Long-Term Efficacy and Safety of Secukinumab in Children and Adolescents with Moderate-to-Severe Chronic Plaque Psoriasis: Four-Year Results of a Randomized, Phase III, Open-Label Trial. Paediatr Drugs. 2025 Nov;27(6):749-759. doi: 10.1007/s40272-025-00715-4. Epub 2025 Aug 28.
• 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.
• Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Papanastasiou P, Bao W, Forrer P, Patekar M. Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study. Paediatr Drugs. 2022 Jul;24(4):377-387. doi: 10.1007/s40272-022-00507-0. Epub 2022 Jun 13.
• Magnolo N, Kingo K, Laquer V, Browning J, Reich A, Szepietowski JC, Keefe D, Mazur R, Ghelani P, Forrer P, Wraith L, Patekar M. A phase 3 open-label, randomized multicenter study to evaluate efficacy and safety of secukinumab in pediatric patients with moderate to severe plaque psoriasis: 24-week results. J Am Acad Dermatol. 2022 Jan;86(1):122-130. doi: 10.1016/j.jaad.2021.08.066. Epub 2021 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	75 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous

Indications