Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366750
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-03-27
Brief Title:
A Study of Barzolvolimab in Patients with Prurigo Nodularis
Sponsor:
Celldex Therapeutics
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab CDX-0159 in Patients with Prurigo Nodularis
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:
None
Brief Summary:
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis
Detailed Description:
The purpose of this study is to assess the efficacy and safety of barzolvolimab CDX-0159 in adults with prurigo nodularis
There is a screening period of approximately 28 days a 24-week double-blind treatment period and a 16-week follow-up period after treatment Participants will be randomly assigned on a 111 ratio to receive barzolvolimab CDX-0159 by subcutaneous injections of 150 mg every 4 weeks Q4W after an initial loading dose of 450 mg 300 mg Q4W after an initial loading dose of 450 mg or placebo Q4W
There is a screening period of approximately 28 days a 24-week double-blind treatment period and a 16-week follow-up period after treatment Participants will be randomly assigned on a 111 ratio to receive barzolvolimab CDX-0159 by subcutaneous injections of 150 mg every 4 weeks Q4W after an initial loading dose of 450 mg 300 mg Q4W after an initial loading dose of 450 mg or placebo Q4W
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 |
|---|---|---|---|
| 2023-510279-80-00 | OTHER | EU CT | None |