This clinical study is designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to <18 years of age, with chronic spontaneous urticaria.
The study will generate data to be analyzed in a separate modelling and simulation study with the objective of i) estimating the relative potency of ligelizumab in adolescent patients compared with adults and ii) proposing a posology for the future treatment of adolescent patients.
The patient population will be treated with ligelizumab as an add-on therapy to approved doses of H1- antihistamines following the guideline on treatment of CSU .
The study consists of 3 distinct study periods: Screening period (up to 4 weeks) Treat period: Day 1 patients are randomized into one of the three treatment arms in 1:2:1 fashion to ligelizumab high dose q4w vs. ligelizumab low dose q4w vs. placebo. During the 24 weeks of treatment, doses are administered on Day 1 then 4, 8, 12, 16, and 20 weeks after randomization. Subjects randomized to placebo will receive placebo on Day 1, Weeks 4 and 8; thereafter they will receive ligelizumab (high dose) at Weeks 12, 16 and 20 such that the same number of patients will, by the end of the study, receive the high dose as the low dose. Safety is assessed every 4 weeks; efficacy is primarily assessed using daily itch and hives scores summed into the weekly UAS7. The treatment period (24 weeks) is followed by a follow-up period of 16 weeks to a maximum of Week 40.
| Condition | Chronic Spontaneous Urticaria |
|---|---|
| Treatment | Placebo, Ligelizumab |
| Clinical Study Identifier | NCT03437278 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 29 May 2023 |
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