OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients (OPTIMA)
This trial will assess the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in patients with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab (150mg or 300mg).
Will also assess the benefit of uptitrating to 300mg dose those patients who are not well-controlled following their first course of treatment with omalizumab 150mg.
Study Type: Interventional
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in CSU Patients
Enrollment: 295
Study Start Date: August 2014
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms:
- Experimental: omalizumab 150mg
- Experimental: omalizumab 300mg
Category | Value |
---|---|
Date last updated at source | 2016-11-27 |
Study type(s) | Interventional |
Expected enrolment | 295 |
Study start date | 2014-08-01 |
Estimated primary completion date | 2016-11-01 |