Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Chronic Idiopathic Urticaria

Treatments: Drug: Omalizimab

Study type: Interventional

Funder types: Other

Identifiers

NCT02166151

0550-31 -RMC

Details and patient eligibility

About

The study is designed to assess the efficacy and safety of monthly injections of Omalizumab 150 mg for 3 consecutive months, in patients with chronic idiopathic urticaria, unresponsive to convetional therapy by antihistamins or oral corticosteroids.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of chronic idiopathic urticaria for 3 months
• failure on treatment with at least 2 antihistamins and systemic corticosteroids or cyclosporin

Exclusion criteria

• physical or cholinergic urticaria
• past treatment in Omalizumab i nprevious year
• parasitic infection
• malignancy in last 5 years
• known sensitivity to Omalizumab

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Omalizumab

Experimental group

Description:

Omalizimab 150 mg S.C. once a month for consecutive 3 months

Treatment:

Drug: Omalizimab