Iatros International | Bloemfontein, South Africa
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About
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria
Full description
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria.
There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
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.
Diagnosis of 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.
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
208 participants in 6 patient groups
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Central trial contact
Celldex Therapeutics
Data sourced from clinicaltrials.gov
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