QGE031 long term safety study in CSU patients E1
Research type
Research Study
Full title
An open label, multicenter, extension study to evaluate the long term safety of QGE031 240mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201
IRAS ID
203698
Contact name
Sinisa Savic
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2015-003636-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
Treatment of Chronic Spontaneous Urticaria (CSU) is a challenge and H1 antihistamines (H1-AH) are the main treatment for CSU. While H1-AH can provide relief for some patients, more than 50% of patients do not find that H1-AH treatment helps enough. Novartis have developed a research drug that may help the symptoms of CSU.
The purpose of this study is to look at how safe QGE031 is over a 52 week period and how effective it is. QGE031 240 mg will be injected under the skin every 4 weeks for 52 weeks in patients with CSU who completed the core QGE031C2201 study. Patients will need to visit the clinic and assessments will be conducted during the 52 week treatment period and the 48-week follow-up period after treatment. The retreatment of patients who received QGE031 in the core study will also be investigated to see how effective retreatment is. In this study, QGE031 is given as an additional treatment to patients that are already receiving H1-AH alone at approved or increased doses or in combination with H2-Antihistamines (H2AH) and/or a Leukotriene Receptor Antagonist (LTRA).
Approximately 240 patients who have been diagnosed with CSU will be enrolled worldwide and it is anticipated that the UK will enrol 15-20 of these patients.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0779
Date of REC Opinion
6 Jul 2016
REC opinion
Further Information Favourable Opinion