Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424470
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
Sponsor:
Keymed Biosciences CoLtd
Organization:
Keymed Biosciences CoLtd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
This study is a multicenter randomized double-blind placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis and observe pharmacokinetic characteristics pharmacological effects and immunogenicity
Detailed Description:
Chronic prurigo CPG is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions Prurigo nodularis PN is the main subtype of CPG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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