Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-23

Study Completion Date

2014-05-09

Brief Summary

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This study will assess the impact of omalizumab on the quality of life improvement when added to the standard therapy in refractory patients suffering from chronic spontaneous urticaria and angioedema.

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Detailed Description

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This study will be conducted using a double-blind, placebo-controlled, randomized, multicenter design to investigate the impact of omalizumab on Quality of Life (QoL) in Chronic Spontaneous Urticaria (CSU) and will assess its effectiveness in reducing and/or inhibiting the occurrence, time-course and severity of angioedema episodes.

Omalizumab is administered subcutaneously every 4 weeks as an add-on therapy to the current approved treatment of adult CSU patients. The treatment period is 28 weeks which is followed by an 8-week follow-up. The study aims to enroll approximately 70 patients.

The study is divided into a 2-week screening period, a 28-week double-blind treatment phase with omalizumab or placebo-omalizumab, and an 8-week follow-up phase.

Conditions

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Chronic Spontaneous Urticaria Angioedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1 Omalizumab

omalizumab once a month via subcutaneous injection.

Group Type EXPERIMENTAL

Omalizumab

Intervention Type BIOLOGICAL

Humanized monoclonal antibody against human IgE

2 Placebo

placebo of omalizumab once a month via subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to omalizumab

Interventions

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Omalizumab

Humanized monoclonal antibody against human IgE

Intervention Type BIOLOGICAL

Placebo

Placebo to omalizumab

Intervention Type DRUG

Other Intervention Names

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IGE025 Placebo for Omalizumab

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine treatment
* Presence of itch an hives for more than 6 weeks
* UAS7 score of more than 14 (range 0-42)
* Patient has history of insufficient response to 4x of the approved dose of H1-antihistamines
* CSU diagnosis for more than 6 months
* Angioedema at least 4x in the last 6 months

Exclusion Criteria

* Patients with non urticaria associated angioedema
* History of hypersensitivity to omalizumab or the rescue medication or to drugs of similar chemical structure
* Evidence of parasitic infection
* Previous treatment with omalizumab within the last 6 months prior to screening
* History of anaphylactic shock
* Woman who are pregnant or breast feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No