Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Condition(s) studied
Investigational drug(s) / intervention(s)
Remibrutinib: Active treatment
Placebo to remibrutinib: Placebo followed by active treatment
Placebo to omalizumab: Placebo followed by active comparator
Omalizumab: Active comparator
Study summary
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).
The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.
Eligibility
Primary outcome measure(s)
- Absolute change from baseline in Weekly Urticaria Activity Score (UAS7) — Week 12
The UAS7 is the sum of the Weekly Hives Severity Score (HSS7 score) and the Weekly Itch Severity Score (ISS7 score). The possible range of the weekly UAS7 score is 0 - 42 (highest activity).
Trial sites (110)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | |
| Novartis Investigative Site | Mendoza | Mendoza Province | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | Bahía Blanca | Argentina | |
| Novartis Investigative Site | CABA | Argentina | |
| Novartis Investigative Site | Capital Federal | Argentina | |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | |
| Novartis Investigative Site | Alphaville Barueri | São Paulo | |
| Novartis Investigative Site | Santo André | São Paulo | |
| Novartis Investigative Site | Sorocaba | São Paulo | |
| Novartis Investigative Site | Sofia | Bulgaria | |
| Novartis Investigative Site | Sofia | Bulgaria | |
| Novartis Investigative Site | Varna | Bulgaria | |
| Novartis Investigative Site | Edmonton | Alberta | |
| Novartis Investigative Site | Hamilton | Ontario | |
| Novartis Investigative Site | Hamilton | Ontario | |
| Novartis Investigative Site | London | Ontario | |
| Novartis Investigative Site | Niagara Falls | Ontario | |
| Novartis Investigative Site | Québec | Quebec | |
| Novartis Investigative Site | Verdun | Quebec | |
| Novartis Investigative Site | Brno | Czechia | |
| Novartis Investigative Site | Plzen Bolevec | Czechia | |
| Novartis Investigative Site | Prague | Czechia | |
| Novartis Investigative Site | Nice | France | |
| Novartis Investigative Site | Grenoble | France | |
| Novartis Investigative Site | La Rochelle | France | |
| Novartis Investigative Site | Pierre-Bénite | France | |
| Novartis Investigative Site | Rouen | France | |
| Novartis Investigative Site | Freiburg im Breisgau | Baden-Wurttemberg | |
| Novartis Investigative Site | Munich | Bavaria | |
| Novartis Investigative Site | Hamburg | Free and Hanseatic City of Hamburg | |
| Novartis Investigative Site | Göttingen | Lower Saxony | |
| Novartis Investigative Site | Stade | Lower Saxony | |
| Novartis Investigative Site | Dresden | Saxony | |
| Novartis Investigative Site | Leipzig | Saxony | |
| Novartis Investigative Site | Halle | Saxony-Anhalt | |
| Novartis Investigative Site | Bad Bentheim | Germany | |
| Novartis Investigative Site | Berlin | Germany | |
| Novartis Investigative Site | Bochum | Germany | |
| Novartis Investigative Site | Bochum | Germany |
+ 70 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06042478 on ClinicalTrials.gov ↗ ← All trials in Italy