drugset / Trial / NCT07414394
Tigulixostat (IBI128) vs Febuxostat in Gout
Phase 3
Active not recruiting
600 enrolled
Innovent Biologics Technology Limited (Shanghai R&D Center)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-03-17
- Primary completion
- 2027-04-30
- Completion
- 2027-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Febuxostat | Small molecule | — | — |
| Subject | Tigulixostat | Small molecule | — | — |