QGE031 dose finding study in CSU patients
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Spontaneous Urticaria (CSU)
IRAS ID
178843
Contact name
Sinisa Savic
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2014-005559-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Treatment of CSU is a challenge and H1 antihistamines (H1-AH) are the mainstay of symptomatic therapy of CSU.While H1-AH at approved doses provide relief for some patients, more than 50% of patients do not respond to H1-AH at regular doses.
This study is designed to determine if QGE031 is superior to placebo as an add on therapy to H1-AH alone at approved or increased doses following the current guideline on treatment in CSU, or in combination with H2-AH and /or a LTRA. The study will also allow comparison of the safety and efficacy of QGE031 to omalizumab in this population.
This study is a Phase 2b, multicentre, randomized, double blind, active and placebo controlled, dose range finding study with the aim to establish a dose response relationship, and, based on the selected dose-response model, to identify a dose which has a benefit to patients with uncontrolled CSU versus omalizumab 300mg, the only alternative anti IgE medication that is currently marketed in many countries.
The study will include a screening period of 2 weeks (Day -14 to Day 1), a treatment period of 20 weeks ( Day 1- to Day 141) during which patients will be administered treatment 5 times at 4 week intervals. Post treatment follow up will consist of a total of 24 weeks with 6 visits 4 weeks apart. There will be 6 treatment arms consisting of QGE031 24mg, 72mg, 120mg and 240mg, Omalizumab (Xolair) 300mg and placebo.
Approximately 360 patients who have been diagnosed with CSU will be enrolled worldwide and it is anticipated that the UK will enrol 25 of these patients.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0735
Date of REC Opinion
16 Jul 2015
REC opinion
Further Information Favourable Opinion