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

Completed · Phase 3

Conditions studied: Moderate to Severe Chronic Plaque-type Psoriasis

In brief

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.

Key facts

Study ID

NCT03668613

Run by

Novartis Pharmaceuticals

People needed

84

Starts

2018-08-29

Expected to finish

2023-09-12

Last updated by the study team

2025-05-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed assent and parental permission (age as per local law) obtained at screening before any assessment is performed.
• Must be 6 to less than 18 years of age at the time of randomization
• Moderate to Severe plaque psoriasis, defined as a PASI score ≥ 12, and IGA mod 2011 score of ≥ 3, and BSA involvement of ≥10%, at randomization.
• Subject being regarded by the investigator to be a candidate for systemic therapy.

You may not qualify if…

• Forms of psoriasis other than chronic plaque-type active at randomization
• Drug-induced psoriasis
• Ongoing use of prohibited treatments
• Female subjects of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 16 weeks after stopping study treatment
• Pregnant or nursing (lactating) females
• Subjects with total WBC count <2,500/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL at screening
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor

Where it is running

• First OC Dermatology — Fountain Valley, California, United States
• Private Practice — Jacksonville, Florida, United States
• Novartis Investigative Site — Lebanon, New Hampshire, United States
• Texas Derm and Laser Specialists . — San Antonio, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Hradec Králové, CZE, Czechia
• Novartis Investigative Site — Prague, Prague 1, Czechia
• Novartis Investigative Site — Tartu, Estonia
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Münster, Germany
• Novartis Investigative Site — Lima, Peru
• Novartis Investigative Site — Warsaw, Mazowian, Poland
• Novartis Investigative Site — Rzeszów, Poland
• Novartis Investigative Site — Wroclaw, Poland
• Novartis Investigative Site — Kazan', Russia
• Novartis Investigative Site — Krasnodar, Russia
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Saint Petersburg, Russia
• Novartis Investigative Site — Esplugues de Llobregat, Barcelona, Spain
• Novartis Investigative Site — Sabadell, Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Valencia, Spain

Full record on ClinicalTrials.gov

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