Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276556
Status:
TERMINATED
Last Update Posted:
2024-02-26
First Post:
2024-02-12
Brief Title:
Extension Study of ABP-671 in Participants With Gout
Sponsor:
Jiangsu Atom Bioscience and Pharmaceutical Co Ltd
Organization:
Jiangsu Atom Bioscience and Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Double-blind Phase 2b3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Redesign of clinical development program for ABP-671 A new long-term safety study after the completion and analysis of Part 1 of ABP-671-301 NCT05818085 is planned and will be conducted using the doses selected for the pivotal studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to assess the safety tolerability and efficacy of ABP-671 in lowering serum uric acid sUA in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 Phase 2b or Part 2 Phase 3
Detailed Description:
None
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