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Efficacy and Safety of Omalizumab in Patients With Severe Acute Urticaria

NCT02191072 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-07-15

No results posted yet for this study

Summary

Efficacy of omalizumab in chronic spontaneous urticaria had been demonstrated in phase II and phase III studies. Clinical symptoms and signs had been significantly reduced with omalizumab as doses of 150 mg and 300 mg at 4-week intervals in patients with chronic spontaneous urticaria who remained symptomatic despite antihistamine treatment. Omalizumab had an onset of effect within a week after initiation. Thus, the investigators hypothesize that omalizumab will be effective in the treatment of severe acute urticaria as add on therapy with a fast onset of action. Objective:To investigate the efficacy and safety of omalizumab in the treatment of severe acute urticaria Study design: This prospective, interventional, single-arm open label study will recruit patients with severe acute urticaria from emergency departments, hospitalized and outpatient departments. The included patients will receive a single subcutaneous dose of 300mg omalizumab therapy. The efficacy of omalizumab will be evaluated by physical examination and assessed by Urticaria Activity Score (UAS) at baseline, 1 hour, Day 1, Day3, Day 7, and 6 weeks after omalizumab therapy. The frequency and severity of treatment-emergent adverse events will also be evaluated

Conditions

  • Urticaria

Interventions

DRUG

omalizumab

a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Tsai Tsen-Fang · Department of Dermatology, National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02191072 on ClinicalTrials.gov