REMIX-2
Research type
Research Study
Full title
A multicenter, randomized, double-blind, placebo-controlled Phase 3 study of remibrutinib (LOU064) to investigate the efficacy, safety and tolerability for 52 weeks in adult chronic spontaneous urticaria patients inadequately controlled by H1-antihistamines.
IRAS ID
1003916
Contact name
Barbara Roemer
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000424-35
Research summary
The study is designed to see if remibrutinib (LOU064) is safe and can help patients who have Chronic Spontaneous Urticaria (CSU). Remibrutinib binds to proteins on specific white blood cells ( mast cells and B cells). These cells play an important role in the development of CSU so by targeting these cells it is hoped that remibrutinib will improve CSU signs and symptoms and lead to a better quality of life. 450 adults with CSU will take part in the study.
At the start of the study participants will have a 2 in 3 possibility of receiving the remibrutinib study treatment for the first 6 months and a 1 in 3 possibility of receiving a placebo (a treatment designed to look like the study drug but has no active effect). Neither the participant nor the study doctor will know what treatment patients are receiving . After 6 months all participants will be given remibrutinib. In addition, all participants will take H1-antihistamine during the entire study. Additional rescue medication, is provided for CSU flare ups.
The study will last for approximately 14 months with 13 study visits. Most visits will last for about 1 hour but some will be longer. Patients will be required to sign a consent form at the start of the study and they will then be examined to see if they meet the entry requirements. This screening process can last up to 4 weeks in this study. Eligible patients will then be randomised to receive either remibrutinib or placebo. Patients will be given an eDiary device (like a tablet) to record information about CSU symptoms and to document any rescue medication taken. The eDiary must be completed daily in the morning and evening throughout the study. At all visits patients will have their pulse and blood pressure measured, blood and urine samples taken and pregnancy tests if applicable. At some visits patients have an electrocardiogram (ECG) and complete patient questionnaires to assess patient reported symptoms and their impact on patients' quality of life.REC name
Wales REC 5
REC reference
21/WA/0296
Date of REC Opinion
15 Nov 2021
REC opinion
Further Information Favourable Opinion