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

Phase 4

Completed

• Conditions: Chronic Idiopathic Urticaria
• Interventions: Biological: placebo; Biological: benralizumab

• Registration Number: NCT03183024
• Lead Sponsor: Jonathan A. Bernstein, MD

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-09-12
• Primary Completion: 2018-11-06
• Study Completion: 2018-11-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo for benralizumab sc given during run-in phase
benralizumab	benralizumab	benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase

Primary Outcome Measures

Name	Time	Method
change in urticarial activity score averaged over 7 days- no units	through study completion, up to 7 months	subject completed form

Secondary Outcome Measures

Name	Time	Method
change in blood eotaxin level (pg/ml)	through study completion, up to 7 months	specific blood test
change in blood anti-TPO level (IU/L)	through study completion, up to 7 months	specific blood test
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
change in blood anti-FCER1 level (kU/l)	through study completion, up to 7 months	specific lab test
change in Blood ECP level (ug/L)	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)

Trial Locations

Locations (1)

Bernstein Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States