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Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

NCT02329223 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2016-09-21

Study results available
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Summary

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.

Conditions

  • Chronic Spontaneous Uriticaria

Interventions

BIOLOGICAL

Omalizumab

Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.

OTHER

Placebo

Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Companies

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 NCT02329223 on ClinicalTrials.gov