Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05030311
Status:
COMPLETED
Last Update Posted:
2024-07-12
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-1
Brief Summary:
The purpose of this study is to establish the efficacy safety and tolerability of remibrutinib LOU064 in adult participants suffering from chronic spontaneous urticaria CSU inadequately controlled by H1-antihistamines in comparison to placebo
Detailed Description:
This is a global multicenter randomized double-blind parallel-group placebo-controlled Phase 3 study investigating the safety tolerability and efficacy of remibrutinib in adult participants with CSU inadequately controlled by second generation H1-antihistamines
Inadequate control of CSU by H1-antihistamines is defined as
The presence of itch and hives for 6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
UAS7 score range 0-42 16 ISS7 score range 0-21 6 and HSS7 score range 0-21 6 during the 7 days prior to randomization Day 1
The study consists of four periods the total study duration is up to 60 weeks Screening period of up to 4 weeks double-blind treatment period of 24 weeks open-label treatment period of 28 weeks and 4 weeks of treatment-free follow up
Eligible participants will be randomly assigned to the treatment arms in a 21 ratio The study population will consist of approximately 450 female and male adult participants 300 in the active arm and 150 in the placebo arm with CSU inadequately controlled by second generation H1-antihistamines at least at locally label approved dose
Inadequate control of CSU by H1-antihistamines is defined as
The presence of itch and hives for 6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period
UAS7 score range 0-42 16 ISS7 score range 0-21 6 and HSS7 score range 0-21 6 during the 7 days prior to randomization Day 1
The study consists of four periods the total study duration is up to 60 weeks Screening period of up to 4 weeks double-blind treatment period of 24 weeks open-label treatment period of 28 weeks and 4 weeks of treatment-free follow up
Eligible participants will be randomly assigned to the treatment arms in a 21 ratio The study population will consist of approximately 450 female and male adult participants 300 in the active arm and 150 in the placebo arm with CSU inadequately controlled by second generation H1-antihistamines at least at locally label approved dose
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 |
|---|---|---|---|
| 2021-000471-37 | EUDRACT_NUMBER | None | None |