Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
NCT01723072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2020-09-09
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.
Conditions
- Chronic Spontaneous Urticaria
- Angioedema
Interventions
- BIOLOGICAL
-
Omalizumab
Humanized monoclonal antibody against human IgE
- DRUG
-
Placebo to omalizumab
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-23
- Primary Completion
- 2014-05-09
- Completion
- 2014-05-09
Countries
- Germany
Study Locations
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