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

Sponsor
LEO Pharma
Study ID
NCT04305327
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Brodalumab — DRUG
    Solution for subcutaneous injection.
  • Ustekinumab — DRUG
    Solution for subcutaneous injection.
  • Placebo — DRUG
    The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.

Study Details

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.

Key Dates

Start date
Dec 7, 2022
Status verified
Jul 2024
Primary completion
May 5, 2023
Completion
May 5, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brodalumab
    Brodalumab for 52 weeks. The dose will be determined by the participant's body weight.
  • Active Comparator: Ustekinumab
    Ustekinumab for 52 weeks. The dose will be determined by the participant's body weight.
  • Placebo Comparator: Placebo/brodalumab
    Placebo for the first 12 weeks and brodalumab for the following 40 weeks. The dose will be determined by the participant's body weight.
  • Placebo Comparator: Placebo/ustekinumab
    Placebo for the first 12 weeks and ustekinumab for the following 40 weeks. The dose will be determined by the participant's body weight.

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12. [ Time Frame: Baseline to Week 12 ]

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