CLOU064F12301: LOU064 in adolescent patients with chronic spontaneous urticaria (CSU)
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled trial to evaluate the efficacy, pharmacokinetics and safety of remibrutinib (LOU064) for 24 weeks in adolescents from 12 to less than 18 years of age with chronic spontaneous urticaria inadequately controlled by H1-antihistamines followed by an optional open-label extension for up to another 3 years and an optional safety long-term treatment-free follow-up period for up to an additional 3 years
IRAS ID
1006342
Contact name
Barbara Roemer
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
The purpose of this trial is to learn if the drug remibrutinib can improve symptoms and is safe to use in adolescents with chronic spontaneous urticaria. The study will also evaluate how the study drug is eliminated from the body in this population.
Chronic spontaneous urticaria (also called CSU) is a chronic skin condition that manifests in hives. Chronic means recurring and lasting for 6 weeks or more. Spontaneous means that there is no known trigger. Urticaria is a medical word for hives, a skin reaction that causes red or white itchy welts. The welts vary in size and appear and fade repeatedly as the reaction runs its course. CSU is often associated with the swelling of the deeper layers of the skin, caused by a build-up of fluid, called angioedema. The symptoms of angioedema can affect any part of the body, but swelling usually affects the eyes, lips and genitals.
Remibrutinib is a drug which can eliminate or lower the CSU symptoms by blocking a protein involved in the events leading to itchy hives and angioedema.
This trial is designed to find out if remibrutinib can reduce the number of itchy hives and episodes of angioedema of CSU. The disease activity is measured by questionnaires the participants have to complete daily. The questionnaires are: Weekly Hives Severity Score (HSS7), Weekly Itch Severity Score (ISS7), Weekly Urticaria Activity Score (UAS7) and Weekly Angioedema Activity Score (AAS7). This trial is also designed to learn (more) about the long-term safety of remibrutinib.
Approximately 84 male and female adolescents (12-17 years of age) with CSU symptoms for >=6 months despite antihistamines treatment will take part in the study. Participation will last around 34 weeks for the main part of the study. Then participants will have the option of continuing with an observation period and receiving further treatment if their symptoms are not controlled. This will last 1-3 years.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0490
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion