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

NCT03183024 — Phase 4, Completed, 12 participants, Jonathan A. Bernstein, MD

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

Registry	NCT03183024
Status	Completed
Phase	Phase 4
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	12 (Actual)
Sponsor	Jonathan A. Bernstein, MD (Other)
Conditions	Chronic Idiopathic Urticaria
Interventions	benralizumab, placebo (Biological)
Dates	start 2017-09-12, primary completion 2018-11-06, completion 2018-11-06, first posted 2017-06-09, last updated 2019-07-10
Locations	1 site in United States

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
placebo	Placebo comparator	Biological: placebo	placebo for benralizumab sc given during run-in phase
benralizumab	Experimental	Biological: benralizumab	benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase

benralizumab (Biological): open-label treatment
placebo (Biological): sterile water to mimic benralizumab

+Outcome measures

Primary outcomes

change in urticarial activity score averaged over 7 days- no units [through study completion, up to 7 months]: subject completed form

Secondary outcomes

change in blood anti-FCER1 level (kU/l) [through study completion, up to 7 months]: specific lab test
change in blood anti-TPO level (IU/L) [through study completion, up to 7 months]: specific blood test
change in Blood ECP level (ug/L) [through study completion, up to 7 months]: specific blood test
change in blood eotaxin level (pg/ml) [through study completion, up to 7 months]: specific blood test
change in RNA testing [through study completion, up to 7 months]: gene expression profile using RNA-sequencing in skin biopsy samples (lesional vs non-lesional skin) (log 2 fold-change)
change in skin biopsy inflammatory cell counts [through study completion, up to 7 months]: inflammatory cell count in skin biopsy (number of cells/sq mm)
change in cytokine quantification in skin biopsy (units/mL) [through study completion, up to 7 months]: skin biopsy

Other outcomes

adverse events [through study completion, up to 7 months]: adverse events
change in blood pressure [through study completion, up to 7 months]: blood pressure- mm Hg
change in pulse rate [through study completion, up to 7 months]: pulse rate- bpm
change in blood urea nitrogen [through study completion, up to 7 months]: blood urea nitrogen lab test - mg/dl

+Eligibility

Sex: All, ages: 19 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Bernstein Clinical Research Center	Cincinnati, Ohio	United States

My Notes

Public

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