Disease and outcomes in CSU patients treated with Omalizumab
Research type
Research Study
Full title
EXPLORE+: Prospective EXamination of Patient characteristics, Levels of disease and Outcomes in chronic spontaneous uRticaria trEatment in Xolair® (omalizumab) patients.
IRAS ID
202514
Contact name
Sinisa Savic
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
This is a Phase IV, multicentre, prospective, non-interventional study to assess the treatment outcomes of omalizumab in CSU patients. Patients will be treated with omazulimab according to routine medical practice and local prescribing. Patients will be required to complete questionnaires either at clinic during their usual visit or by post and their medical treatment information will be collected. There will be no change to the patients' routine treatment and there will be no requirements for any additional visit.
Approximately 250 patients who have chronic spontaneous urticaria that is not being controlled by the use of H1AH treatment and have been prescribed omalizumab will be recruited in the United Kingdom over an approximately 12-month recruitment period. The duration of the study will be 2 years from the first routine treatment with omalizumab.
The study will be divided into 3 phases: an initial treatment phase, a treatment break phase for patients who stop the treatment following a clinical response as recommended by their physician, and a retreatment phase for patients whose CSU symptoms return and their physician prescribes omalizumab again.
REC name
West of Scotland REC 3
REC reference
16/WS/0103
Date of REC Opinion
17 Jun 2016
REC opinion
Further Information Favourable Opinion