Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Severe Plaque-type Psoriasis

In brief

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.

Key facts

Study ID

NCT02471144

Run by

Novartis Pharmaceuticals

People needed

162

Starts

2015-09-29

Expected to finish

2023-03-30

Last updated by the study team

2023-10-11

Who can join

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

You may qualify if…

• Must be 6 to less than 18 years of age at the time of randomization
• Plaque-type psoriasis history for at least 3 months.
• Severe plaque-type psoriasis meeting all of the following three criteria:
• PASI score of 20 or greater,
• Investigator's Global Assessment (IGA) score of 4
• Total body surface area (BSA) affected of 10% or greater.
• Patient being regarded by the investigator to be a candidate for systemic therapy because of:
• inadequate control of symptoms with topical treatment, or
• failure to respond to or tolerate previous systemic treatment and/or UV therapy

You may not qualify if…

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization.
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Medellín, Antioquia, Colombia
• Novartis Investigative Site — Bogotá, Colombia
• Novartis Investigative Site — Alexandria, Egypt
• Novartis Investigative Site — Cairo, Egypt
• Novartis Investigative Site — Tartu, Estonia
• Novartis Investigative Site — Amiens, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Bad Bentheim, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Erlangen, Germany
• Novartis Investigative Site — Mainz, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Münster, Germany
• Novartis Investigative Site — Guatemala City, Guatemala
• Novartis Investigative Site — Guatemala City, Guatemala
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Afula, Israel

Full record on ClinicalTrials.gov

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