Status:
TERMINATED
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis
Lead Sponsor:
LEO Pharma
Conditions:
Psoriasis
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04305327
Start Date
December 7 2022
End Date
May 5 2023
Last Update
March 14 2025
Active Locations (35)
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1
LEO Pharma Investigational Site
Brussels, Belgium, 1200
2
LEO Pharma Investigational Site
Liège, Belgium, B-4000
3
LEO Pharma Investigational Site
Toulouse, France, 31059
4
LEO Pharma Investigational Site
Bad Bentheim, Germany, 48455