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

Chronic Idiopathic Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183024
• Other study ID #: SAIRB-17-0036
• Status: Completed
• Phase: Phase 4
• Start date: September 12, 2017
• Est. completion date: November 6, 2018

Study information

• Verified date: July 2019
• Source: Bernstein Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 6, 2018
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

Intervention

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

Locations

Country	Name	City	State
United States	Bernstein Clinical Research Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jonathan A. Bernstein, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	adverse events	through study completion, up to 7 months
Other	change in blood pressure	blood pressure- mm Hg	through study completion, up to 7 months
Other	change in pulse rate	pulse rate- bpm	through study completion, up to 7 months
Other	change in blood urea nitrogen	blood urea nitrogen lab test - mg/dl	through study completion, up to 7 months
Primary	change in urticarial activity score averaged over 7 days- no units	subject completed form	through study completion, up to 7 months
Secondary	change in blood anti-FCER1 level (kU/l)	specific lab test	through study completion, up to 7 months
Secondary	change in blood anti-TPO level (IU/L)	specific blood test	through study completion, up to 7 months
Secondary	change in Blood ECP level (ug/L)	specific blood test	through study completion, up to 7 months
Secondary	change in blood eotaxin level (pg/ml)	specific blood test	through study completion, up to 7 months
Secondary	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
Secondary	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
Secondary	change in cytokine quantification in skin biopsy (units/mL)	skin biopsy	through study completion, up to 7 months