Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-28 @ 1:38 PM
Study NCT ID:
NCT05936268
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Gensci 048-203
Brief Summary:
To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy
Detailed Description:
Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.
Study Oversight
Has Oversight DMC:
False
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?: