Clinical Trial

Tigulixostat (IBI128) vs Febuxostat in Gout

Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-10.
Status change: Not Yet Recruiting → Recruiting 2026-03-24
Trial Details
NCT Number NCT07414394
Lead Sponsor Innovent Biologics Technology Limited (Shanghai R&D Center)
Conditions Gout
Enrollment 600 participants
Start Date 2026-03-17
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-25