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Montpelier Cedex, France

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  • A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

    This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

    Phase

    3

    Span

    147 weeks

    Sponsor

    Celldex Therapeutics

    Villareal

    Recruiting

1-1 of 1
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