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

Jonathan A. Bernstein, MD

Status and phase: Completed; Phase 4

Conditions: Chronic Idiopathic Urticaria

Treatments: Biological: benralizumab; Biological: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03183024

SAIRB-17-0036

Details and patient eligibility

About

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

Full 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

Enrollment: 12 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo for benralizumab sc given during run-in phase

Treatment:

Biological: placebo

benralizumab

Experimental group

Description:

benralizumab sc once a month for 3 months for subjects who meet inclusion/exclusion criteria after run-in phase

Treatment:

Biological: benralizumab