Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Launched by LEO PHARMA · Mar 10, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Subject was diagnosed with chronic plaque psoriasis at least 6 months before randomisation.
• • Subject has a diagnosis of moderate-to-severe plaque psoriasis as defined by PASI ≥12, sPGA ≥3, and body surface area ≥10% at screening and at baseline.
• • Subject, in whom topical therapy is not adequate, and who is a candidate for systemic therapy.
• • Subject has no evidence of active or latent tuberculosis according to local standard of care.
• Key Exclusion Criteria:
• • Subject is diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions (e.g., eczema).
• • Subject has been vaccinated with a tetanus toxoid-containing vaccine ≤18 months prior to first dose of investigational medicinal product (IMP). For EU and UK: Subject has been vaccinated with a TT-containing vaccine within 5 years prior to the first dose of IMP.
• • Subject has developed or experienced either Guillian-Barre syndrome, encephalopathy, Arthus-type hypersensitivity, or severe allergic reactions in connection with previous Tdap or Td vaccine.
• • Subject with chronic or recurrent infections, or active infection, systemically treated within 4 weeks prior to first dose of IMP.
• • Subject has a known history of Crohn's disease.
• • Subject has any active malignancy or a history of any malignancy within 5 years.
• • Subject has a history of suicidal behaviour and has suicidal ideation with some intent to act or specific plan and intent.
• • Subject has a history of depressive disorder with severe episode(s) within the last 2 years.
• • Subject has received anti-IL-12/23p40 for less than 12 months prior to the first dose of IMP or has previously no response to anti-IL-12/23p40 therapy.
• • Subject has previously received anti-IL-17 therapy.