CLOU064A2201E1 - Extension study to evaluate LOU064 in CSU
Research type
Research Study
Full title
An open-label, multicenter, extension study to evaluate the long-term safety and tolerability of LOU064 in eligible subjects with CSU who have participated in preceding studies with LOU064
IRAS ID
231951
Contact name
John Reed
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2019-001074-29
Duration of Study in the UK
2 years, 6 months, 13 days
Research summary
This study will evaluate long-term safety and tolerability as well as efficacy
of LOU064 in patients who have completed a preceding study with LOU064 in CSU.Treatment of CSU is a challenge and H1 antihistamines (H1AH)are the recommended first line treatment of CSU. While H1AH at approved doses provide relief for some patients, less than 40% of patients respond to H1AH at regular doses. Omalizumab is the only other licensed treatment for CSU. Omalizumab is a highly effective third line therapy for CSU subjects, however, less than 50% of subjects treated with Omalizumab reach a complete control of signs and symptoms of CSU. Therefore, there is high medical need for new treatment options for patients with CSU.
The purpose of this study is to evaluate whether long-term treatment (1 year) with LOU064 is safe and well tolerated when administered to adult patients suffering from CSU who have completed a preceding study with LOU064 in CSU. Additionally, the time to relapse after the interruption of treatment with LOU064 will be assessed.
Depending on the severity of patients CSU, study participation will last from 12 weeks minimum to 1.5 years maximum.
Approximately 250 patients will participate in this study across 15 countries worldwide. 8 patients will participate in the UK.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0260
Date of REC Opinion
10 Oct 2019
REC opinion
Further Information Favourable Opinion