Study of efficacy and safety of secukinumab in pediatric patients with severe plaque psoriasis

A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223229

Enrollment

Registered

2016-06-03

Start date

2016-07-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Chronic Pediatric Plaque Psoriasis

Interventions

Experimental: Secukinumab low dose Depending on weight group subject will receive per dose a) 75 mg if weighing less than 50 kg b) 150 mg if weighing 50 kg or more. Secukinumab injections (one or two

thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232. Experimental: Secukinumab high dose Depending on weight group subject will receive per dose a) 75 mg if we

thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232. Placebo Comparator: Placebo Placebo secukinumab (one or two subcutaneous injections per dose, depending on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *PASI score of 20 or greater at the time of randomization (Wash-out: Other systemic immunomodulating treatments: 4weeks, Phototherapy: 2weeks, Biological immunomodulating agents: 12weeks)

Exclusion criteria

Exclusion criteria: *Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization *Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
efficacy PASI 75 and IGA 0/1	—

Secondary

Measure	Time frame
efficacy PASI 50, 90, 100	—

Countries

Belgium, Colombia, Egypt, Estonia, France, Germany, Guatemala, Hungary, Israel, Italy, Latvia, Poland, Rumania, Russia, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma K. K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026