Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:21 AM
Study NCT ID:
NCT07414394
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tigulixostat (IBI128) vs Febuxostat in Gout
Sponsor:
Innovent Biologics Technology Limited (Shanghai R&D Center)
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout
Status:
RECRUITING
Status Verified Date:
2026-03
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 primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level \< 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: