Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445023
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-31
Brief Title:
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment EMBARQ-CSU1
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMBARQ-CSU1
Brief Summary:
The purpose of this study is to establish the efficacy safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria CSU inadequately controlled by non-sedating second generation 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 efficacy safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria CSU who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose
There is a screening period of up to 4 weeks followed by a 24-week placebo-controlled treatment period a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period
Approximately 915 adult participants 610 in the active arms and 305 in the placebo arm will be randomly assigned to the treatment arms
There is a screening period of up to 4 weeks followed by a 24-week placebo-controlled treatment period a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period
Approximately 915 adult participants 610 in the active arms and 305 in the placebo arm will be randomly assigned to the treatment arms
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 |
|---|---|---|---|
| 2024-513208-32-00 | CTIS | None | None |