A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
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.
Key Inclusion Criteria:
Males and females, >/= 18 years of age.
Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).
CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
Normal blood counts and liver function tests.
Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
Willing and able to complete a daily symptom electronic diary and comply with study visits.
Participants with and without prior biologic experience are eligible.
Key Exclusion Criteria:
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Indianapolis, Indiana 46250, United States
North Charleston, South Carolina 29420, United States
Buenos Aires, Buenos Aires C1054, Argentina
Buenos Aires, Buenos Aires C1121ABE, Argentina
CABA, Buenos Aires F.D. 1012, Argentina
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CABA, Buenos Aires F.D. C14141AIF, Argentina
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