Back to resultsTreatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
Primary Purpose
Chronic Idiopathic Urticaria
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
benralizumab
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Urticaria
Eligibility Criteria
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
Sites / Locations
- Bernstein Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
benralizumab
Arm Description
placebo for benralizumab sc given during run-in phase
benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase
Outcomes
Primary Outcome Measures
change in urticarial activity score averaged over 7 days- no units
subject completed form
Secondary Outcome Measures
change in blood anti-FCER1 level (kU/l)
specific lab test
change in blood anti-TPO level (IU/L)
specific blood test
change in Blood ECP level (ug/L)
specific blood test
change in blood eotaxin level (pg/ml)
specific blood test
change in RNA testing
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
inflammatory cell count in skin biopsy (number of cells/sq mm)
change in cytokine quantification in skin biopsy (units/mL)
skin biopsy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183024
Brief Title
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
Official Title
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan A. Bernstein, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
single-blind
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo for benralizumab sc given during run-in phase
Arm Title
benralizumab
Arm Type
Experimental
Arm Description
benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase
Intervention Type
Biological
Intervention Name(s)
benralizumab
Intervention Description
open-label treatment
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
sterile water to mimic benralizumab
Primary Outcome Measure Information:
Title
change in urticarial activity score averaged over 7 days- no units
Description
subject completed form
Time Frame
through study completion, up to 7 months
Secondary Outcome Measure Information:
Title
change in blood anti-FCER1 level (kU/l)
Description
specific lab test
Time Frame
through study completion, up to 7 months
Title
change in blood anti-TPO level (IU/L)
Description
specific blood test
Time Frame
through study completion, up to 7 months
Title
change in Blood ECP level (ug/L)
Description
specific blood test
Time Frame
through study completion, up to 7 months
Title
change in blood eotaxin level (pg/ml)
Description
specific blood test
Time Frame
through study completion, up to 7 months
Title
change in RNA testing
Description
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
Title
change in skin biopsy inflammatory cell counts
Description
inflammatory cell count in skin biopsy (number of cells/sq mm)
Time Frame
through study completion, up to 7 months
Title
change in cytokine quantification in skin biopsy (units/mL)
Description
skin biopsy
Time Frame
through study completion, up to 7 months
Other Pre-specified Outcome Measures:
Title
adverse events
Description
adverse events
Time Frame
through study completion, up to 7 months
Title
change in blood pressure
Description
blood pressure- mm Hg
Time Frame
through study completion, up to 7 months
Title
change in pulse rate
Description
pulse rate- bpm
Time Frame
through study completion, up to 7 months
Title
change in blood urea nitrogen
Description
blood urea nitrogen lab test - mg/dl
Time Frame
through study completion, up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
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