CLOU064M12301
Research type
Research Study
Full title
A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines
IRAS ID
1009784
Contact name
Morgane Laurent
Contact email
Sponsor organisation
Novartis Pharma UK Ltd
Clinicaltrials.gov Identifier
Research summary
The purpose of the trial is to find out if the trial drug LOU064 (remibrutinib) is safe, how well it is tolerated in the
body, and how well it works in the treatment of chronic inducible urticaria (CINDU) in adults who are taking
antihistamines. Urticaria is another name for itchy hives. When there is a defined trigger that causes the itchy hives
to occur, it is called Chronic inducible urticaria (CINDU). The term ‘CINDU’ groups all types of inducible
urticarias in one group, without regard to the type of trigger that is causing the itchy hives to occur. This trial will
only be treating patients whose urticaria is caused by physical contact such as friction (symptomatic
dermographism), exposure to cold (cold urticaria), or related with an increase in body temperature due to reasons
such as exercise (cholinergic urticaria).
LOU064, the study treatment that is being tested, is for oral use. It is a relatively small molecule that binds to
specific proteins of cells of the immune system. Among these cells are B cells, mast cells, and basophils (all are a
type of white blood cell) which play an important role in the development of CINDU. By acting on these types of
cells, LOU064 may be able to improve signs and symptoms of the disease and may lead to a better quality of life.
This is a multicenter, randomized, double-blind placebo-controlled basket study. There are two parts of this clinical
trial. The first part is called the Core period and the second part is called the Optional Open-Label period.
In the Core period, participants are participating for 52 weeks. The first 24 weeks of the Core period is doubleblind
and placebo controlled. The following 28 weeks, all participants will be on study treatment (LOU064).
The Optional Open-Label period lasts up to 3 years for eligible participants who are benefiting from study
treatment and want to continue receiving study treatment.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0172
Date of REC Opinion
12 Jul 2024
REC opinion
Further Information Favourable Opinion