Tigulixostat safe at all doses in lowering serum urate levels: CLUE trial

Tigulixostat is safe at all doses, the researchers mentioned.

Researchers evaluated the safety and efficacy of Tigulixostat, a non-purine xanthine oxidase inhibitor, in lowering sUA levels in gout patients with a history of hyperuricemia.

The study was a randomized, double-blind, placebo-controlled, parallel-group, dose-finding phase II trial. Gout patients were randomly assigned to receive daily 50 mg, 100 mg, or 200 mg orally of tigulixostat or placebo for 12 weeks. The primary endpoint is <5.0 mg/dL of serum urate.

The study results could be summarised as follows:

• There was a total of 143 patients.
• Thirty-four patients, 38 patients and 37 patients received 50 mg, 100 mg, and 200 mg tigulixostat, respectively.
• 47.1% in 50 mg, 44.7% in 100 mg, and 62.2% in 200 mg achieved an sUA level of <5.0 mg/dL compared to the placebo at week 12.
• In the placebo group, only 2.9% achieved the range.
• The mean percentage for sUA level change was higher in the tigulixostat dose groups (−38.8% to −61.8%) than in the placebo group.
• In the tigulixostat and placebo groups, the gout flare rate requiring rescue treatment ranged from 9.4% to 13.2%.
• The adverse events incidence was 50.0% to 56.8% by the group with mild to moderate severity.