The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
Males and females, >/= 18 years of age.
Diagnosis of cold induced urticaria or symptomatic dermographism >/= 3 months.
The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
Women who are pregnant or nursing.
Clearly defined cause for chronic urticaria.
Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.
Medical condition that would cause additional risk or interfere with study procedures.
Celldex Therapeutics
Lead sponsor