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.
Parallel
Barzolvolimab
DrugSubcutaneous Administration
Matching Placebo
DrugSubcutaneous Administration
Complete response to provocation testing at Week 12
Proportion of Cold Induced Urticaria \[ColdU\] participants with complete response in Critical Temperature Threshold (CTT) or proportion of Symptomatic Dermographism \[SD\] participants with complete response in Critical Friction Threshold at Week 12. * For ColdU patients, a complete response is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest® * For SD patients, a complete response test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
Complete response to provocation testing at Week 24 for Cold Induced Urticaria participants
Proportion of Cold Induced Urticaria participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Complete response to provocation testing at Week 24 for Symptomatic Dermographism
Proportion of Symptomatic Dermographism participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 24. Temperature Threshold (CTT) following the TempTest® 4.0 at Week 24.
Improvement in clinical symptoms of itch at Week 12
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 12 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
Improvement in clinical symptoms of itch at Week 24
Change from baseline in worst itch-numerical rating scale (WI-NRS) at Week 24 (on a scale of 0-10 in which no itch/burning/pain = 0 and worst ever is = 10).
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