Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02166151

Enrollment

Registered

2014-06-18

Start date

2014-07-31

Completion date

2016-06-30

Last updated

2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Urticaria

Brief summary

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.

Interventions

DRUGOmalizimab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with ≥ 50% Decrease in Urticaria Activity Score (UAS)	3 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026