A Phase 4 interventional study of benralizumab and placebo in Chronic Idiopathic Urticaria, sponsored by Jonathan A. Bernstein, MD. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-10.
Sponsored by Jonathan A. Bernstein, MD · Phase 4, Interventional, and Treatment
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
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's enrollment of 12 is below the median of 61 across 174 interventional studies indexed under Urticaria.
Browse Urticaria studies →Jonathan A. Bernstein, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo for benralizumab sc given during run-in phase
Biological: placebo
benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase
Biological: benralizumab
open-label treatment
sterile water to mimic benralizumab
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
adverse events
adverse events
Time frame: through study completion, up to 7 months
change in blood pressure
blood pressure- mm Hg
Time frame: through study completion, up to 7 months
change in pulse rate
pulse rate- bpm
Time frame: through study completion, up to 7 months
change in blood urea nitrogen
blood urea nitrogen lab test - mg/dl
Time frame: through study completion, up to 7 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Jonathan A. Bernstein, MD