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Clinical trial

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients (OPTIMA)

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Last updated:1st Aug 2014
Identifier: NCT02161562

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

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