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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses.

The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma
• Treatments: Antibodies, Monoclonal; Brodalumab; Ustekinumab

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's immunisations are up-to-date according to national immunisation programme schedule as specified by country-specific paediatric health authorities. Missing an adolescent dose of combined tetanus, diphtheria, and pertussis (Tdap) or combined tetanus and diphtheria (Td) vaccine is accepted.

• Subject does not have active or history of active tuberculosis, or previously inadequately treated for latent tuberculosis.

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).

• 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.