A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients with Hyperuricemia

Conditions

Gout with hyperuricemia

Brief summary

Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.

Detailed description

Proportion of subjects with sUA levels <5.0 mg/dL sustained at Months 4, 5, and 6., Proportion of subjects with at least one gout flare from Month 6 to Month 12., Proportion of subjects with complete resolution (100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression) of ≥1 target tophus by Month 12., Adverse Events (AEs)., Serious adverse events (SAEs)., Treatment-Emergent Adverse events (TEAEs)., Adverse Events of Special Interest (AESI) including MACE, hepatic injury, renal events, and serious skin and hypersensitivity reactions., Physical examinations, vital signs, clinical safety laboratory parameters, or ECGs.

Saag KG, Dalbeth N, Hsu CY, Kuo CF, Nuki G, Perez-Ruiz F, White WB, Hariri A, Lee Y, Jang Y, Han S, Choi HK.

2025-02-08

10.1016/j.cct.2025.107843

Interventions

DRUGAllopurinol OE Capsule

DRUGCOLCHICINE

DRUGTigulixostat 200 mg Placebo Tablet

DRUGNAPROXEN

DRUGTigulixostat

DRUGAllopurinol Placebo Capsules

DRUGTigulixostat 100 mg Placebo Tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of subjects with sUA levels <6.0 mg/dL sustained at Months 4, 5, and 6.	—

Secondary

Measure	Time frame
Proportion of subjects with sUA levels <5.0 mg/dL sustained at Months 4, 5, and 6., Proportion of subjects with at least one gout flare from Month 6 to Month 12., Proportion of subjects with complete resolution (100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression) of ≥1 target tophus by Month 12., Adverse Events (AEs)., Serious adverse events (SAEs)., Treatment-Emergent Adverse events (TEAEs)., Adverse Events of Special Interest (AESI) including MACE, hepatic injury, renal events, and serious skin and hypersensitivity reactions., Physical examinations, vital signs, clinical safety laboratory parameters, or ECGs.	—

Measure

Time frame

Proportion of subjects with sUA levels <5.0 mg/dL sustained at Months 4, 5, and 6., Proportion of subjects with at least one gout flare from Month 6 to Month 12., Proportion of subjects with complete resolution (100% resolution of at least one target tophus, no new tophi appearing, and no single tophus showing progression) of ≥1 target tophus by Month 12., Adverse Events (AEs)., Serious adverse events (SAEs)., Treatment-Emergent Adverse events (TEAEs)., Adverse Events of Special Interest (AESI) including MACE, hepatic injury, renal events, and serious skin and hypersensitivity reactions., Physical examinations, vital signs, clinical safety laboratory parameters, or ECGs.

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Countries

Belgium, Bulgaria, Czechia, France, Germany, Italy, Lithuania, Poland, Spain

Outcome results

None listed