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

Last Updated: 2016-09-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Spontaneous Uriticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omalizumab 300 mg

Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.

Group Type EXPERIMENTAL

Omalizumab

Intervention Type BIOLOGICAL

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

Omalizumab 150 mg

Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.

Group Type EXPERIMENTAL

Omalizumab

Intervention Type BIOLOGICAL

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

Placebo

Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Omalizumab

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Xolair

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
* Chronic spontaneous urticaria diagnosis for 6 months

Exclusion Criteria

* Weight less than 20 kg
* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
* Evidence of parasitic infection
* Any other skin diseases than chronic spontaneous urticaria with chronic itching
* Previous treatment with omalizumab
* Contraindications to diphenhydramine
* History of anaphylactic shock
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to omalizumab or to drugs of similar chemical classes
* Pregnant or nursing (lactating) women

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers