Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody

Study Overview
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Brief Summary
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Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

Detailed Description
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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

Official Title
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Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody

Conditions
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Chronic Idiopathic Urticaria

Intervention / Treatment
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* Biological: benralizumab
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines Exclusion Criteria: hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo for benralizumab sc given during run-in phase | Biological: placebo<br>* sterile water to mimic benralizumab<br>|
| Experimental: benralizumab<br>benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase | Biological: benralizumab<br>* open-label treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in urticarial activity score averaged over 7 days- no units | subject completed form | through study completion, up to 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in blood anti-FCER1 level (kU/l) | specific lab test | through study completion, up to 7 months | 
| change in blood anti-TPO level (IU/L) | specific blood test | through study completion, up to 7 months | 
| change in Blood ECP level (ug/L) | specific blood test | through study completion, up to 7 months | 
| change in blood eotaxin level (pg/ml) | specific blood test | 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) | 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) | through study completion, up to 7 months | 
| change in cytokine quantification in skin biopsy (units/mL) | skin biopsy | through study completion, up to 7 months |