Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment
Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
open-label treatment
sterile water to mimic benralizumab
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
change in urticarial activity score averaged over 7 days- no units
subject completed form
Time frame: through study completion, up to 7 months
change in blood anti-FCER1 level (kU/l)
specific lab test
Time frame: through study completion, up to 7 months
change in blood anti-TPO level (IU/L)
specific blood test
Time frame: through study completion, up to 7 months
change in Blood ECP level (ug/L)
specific blood test
Time frame: through study completion, up to 7 months
change in blood eotaxin level (pg/ml)
specific blood test
Time frame: through study completion, up to 7 months
change in RNA testing
gene expression profile using RNA-sequencing in skin biopsy samples (lesional vs non-lesional skin) (log 2 fold-change)
Time frame: through study completion, up to 7 months
change in skin biopsy inflammatory cell counts
inflammatory cell count in skin biopsy (number of cells/sq mm)
Time frame: through study completion, up to 7 months
change in cytokine quantification in skin biopsy (units/mL)
skin biopsy
Time frame: through study completion, up to 7 months
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