Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy (X-ACT)

Novartis

Status and phase: Completed; Phase 3

Conditions: Angioedema; Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Biological: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01723072

CIGE025EDE16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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91 participants in 2 patient groups, including a placebo group

1 Omalizumab

Experimental group

Description:

omalizumab once a month via subcutaneous injection.

Treatment:

Biological: Omalizumab

2 Placebo

Placebo Comparator group

Description:

placebo of omalizumab once a month via subcutaneous injection

Treatment:

Drug: Placebo