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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Urticaria
• Intervention / Treatment: Biological: placebo; Biological: benralizumab

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo; placebo for benralizumab sc given during run-in phase	Biological: placebo; sterile water to mimic benralizumab
EXPERIMENTAL: benralizumab; benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase	Biological: benralizumab; open-label treatment

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events	adverse events	through study completion, up to 7 months
change in blood pressure	blood pressure- mm Hg	through study completion, up to 7 months
change in pulse rate	pulse rate- bpm	through study completion, up to 7 months
change in blood urea nitrogen	blood urea nitrogen lab test - mg/dl	through study completion, up to 7 months

Collaborators and Investigators

• Sponsor: Jonathan A. Bernstein, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2017
• Primary Completion (ACTUAL): November 6, 2018
• Study Completion (ACTUAL): November 6, 2018

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (ACTUAL): June 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: SAIRB-17-0036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No