Conditions: Chronic Spontaneous Urticaria Angioedema
Keywords: Chronic spontanous urticaria, refractory CSU, Angioedema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: omalizumab once a month via subcutaneous injection. arm 2: placebo of omalizumab once a month via subcutaneous injection

Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Humanized monoclonal antibody against human IgE intervention 2: Placebo to omalizumab

Protocol document: