Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169891
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-30
Brief Title:
A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Sponsor:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Organization:
Sunshine Guojian Pharmaceutical Shanghai Co Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-blind Double-dummy Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout
Detailed Description:
Study SSGJ-613-AG-III-01 is a phase 3 multicenter randomized double-blind double-dummy active-controlled parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated intolerant or lack efficacy to non-steroidal anti-inflammatory drugs NSAIDs andor colchicine The entire treatment period is 48 weeks consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks
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