Ignite Creation Date:
2024-05-06 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05032157
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2021-08-19
Brief Title:
A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official 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 CSU Patients Inadequately Controlled by H1-antihistamines
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMIX-2
Brief Summary:
The purpose of this study was to establish the efficacy safety and tolerability of Remibrutinib 25 mg bid in adult patients suffering from chronic spontaneous urticaria CSU inadequately controlled by second generation H1-antihistamines H1 AHs in comparison to placebo
Detailed Description:
The study consisted of four periods the total study duration was up to 60 weeks Screening period of up to 4 weeks Double-blind placebo-controlled treatment period of 24 weeks Open-label treatment period with Remibrutinib period of 28 weeks and treatment free follow-up period of 4 weeks
The planned sample size was approximately 450 patients randomized in 21 ratio to Remibrutinib or placebo arm 300 in the Remibrutinib arm and 150 in placebo arm
There are two primary objective scenarios based on regional regulatory precedent and Health Authorities feedback These two primary objective scenarios were tested in two distinct testing strategies scenario with UAS7 as the primary efficacy endpoint and scenario with ISS7 and HSS7 as the co-primary efficacy endpoints Distinctions in the secondary objectives reflect the corresponding scenario the primary objective in one scenario is presented as secondary objective-s in another The other secondary objectives are identical in both scenarios
The planned sample size was approximately 450 patients randomized in 21 ratio to Remibrutinib or placebo arm 300 in the Remibrutinib arm and 150 in placebo arm
There are two primary objective scenarios based on regional regulatory precedent and Health Authorities feedback These two primary objective scenarios were tested in two distinct testing strategies scenario with UAS7 as the primary efficacy endpoint and scenario with ISS7 and HSS7 as the co-primary efficacy endpoints Distinctions in the secondary objectives reflect the corresponding scenario the primary objective in one scenario is presented as secondary objective-s in another The other secondary objectives are identical in both scenarios
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-000424-35 | EUDRACT_NUMBER | None | None |