Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-26 @ 10:46 AM
Study NCT ID:
NCT06366750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Barzolvolimab in Patients With Prurigo Nodularis
Sponsor:
Celldex Therapeutics
Organization:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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 1:1:1 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.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
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 1:1:1 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.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-510279-80-00 | OTHER | EU CT | View |