CQGE031C2303: Ligelizumab in the treatment of CSU
Research type
Research Study
Full title
A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines
IRAS ID
262779
Contact name
Sinisa Savic
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-000840-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 27 days
Research summary
Chronic Spontaneous Urticaria (CSU) is defined as the spontaneous occurrence of itchy wheals (hives), angioedema or both lasting for at least 6 weeks. CSU can be
debilitating and is associated with intense itching, having a major impact on patient’s well-being.The purpose of this study is to establish efficacy and safety of ligelizumab, a monoclonal antibody against IgE, in adult and adolescent subjects with CSU, who remain symptomatic despite standard of care treatment by demonstrating better efficacy over Xolair® (omalizumab) when added to H1-antihistamines at approved doses, over 12 months of treatment and a follow-up period of 12 weeks.
Approximately 920 adults patients have been treated with Ligelizumab in clinical studies to date.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0218
Date of REC Opinion
2 Oct 2019
REC opinion
Further Information Favourable Opinion