CLOU064A2304: A Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib
Research type
Research Study
Full title
A global, multicenter, randomized, double-blind, double dummy, parallel-group, Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib 25 mg b.i.d. in comparison to placebo with omalizumab 300 mg every 4 weeks as active control over 52 weeks in adult patients with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines
IRAS ID
1007518
Contact name
Barbara Roemer
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
The purpose of this trial is to learn if the trial drug, remibrutinib, is safe, tolerable and reduces the symptoms of chronic spontaneous urticaria, also called CSU. Wheals and hives, also known as itching in CSU, involves a process at the cellular level that allows the release of histamine, proteases and cytokines. This process induces widening of blood vessels and also increases their permeability, leading to the stimulation of sensory nerve endings that are close by. As a consequence, there is swelling, redness and itching in the affected skin. CSU can be debilitating and can have a major impact on patients' quality of life.
Remibrutinib is designed to reduce the severity of itch and hives by inhibiting a protein that can trigger the release of the substances mentioned above.
The trial is designed to find out if remibrutinib is better than placebo (a dummy drug) at controlling or reducing the symptoms of itch and hives associated with CSU. It will also compare how safe remibrutinib use is compared to omalizumab, sometimes known as Xolair®, which is a drug also used to treat CSU.
There are 2 scenarios that are being evaluated depending on how CSU symptoms are analysed in this trial. In the 1st scenario, the symptoms, itch and hives, are combined in the Weekly Urticaria Activity Score (UAS7). In the 2nd scenario, the Weekly Itch Severity Score (ISS7) and Weekly Hives Severity Score (HSS7) are analysed separately. Both consider the symptoms that were present during a week.
468 adults (over 18 years old) from 24 countries are expected to participate in this study. Participation will last for up to 72 weeks, including up to 4 weeks screening period, 52 weeks treatment period and 16 weeks follow-up period. After the 52-week treatment period, participants may have an option to enrol into an extension study to continue to receive treatment. From the UK, approximately 6 participants will take part. The study will take place in 4-5 hospitals in England.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0223
Date of REC Opinion
22 Nov 2023
REC opinion
Further Information Favourable Opinion