Burke Pharmaceutical Research | Hot Springs, AR
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Males and females, >/= 18 years of age.
Diagnosis of chronic spontaneous urticaria (CSU) >/= 6 months.
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.
Primary purpose
Allocation
Interventional model
Masking
915 participants in 4 patient groups
There are currently no registered sites for this trial.
Central trial contact
Celldex Therapeutics
Start date
Jul 19, 2024 • 5 months ago
Today
Jan 08, 2025
End date
Oct 01, 2026 • in 1 year and 8 months
Lead Sponsor
Data sourced from clinicaltrials.gov
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