Phase 2 Study to Test Dotinurad for Treating Adults With Gout Who Cannot Take Xanthine Oxidase Inhibitors or Have Failed Uricase Treatment

What this Trial Is About

Researchers are evaluating dotinurad, an oral drug, to lower serum uric acid levels in adults with gout who cannot tolerate xanthine oxidase inhibitors XOI or whose uricase treatment has failed. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess the drugs effectiveness and safety in this specific population. The primary goal is to see how many participants achieve a serum uric acid level below 6.0 mgdL at 24 weeks. Participants will be divided into two groups. One group will take dotinurad for 36 weeks, split into a 24-week initial period followed by a 12-week continuation. The other group will take a placebo for the first 24 weeks and then switch to dotinurad for the final 12 weeks. Dotinurad is given as an oral tablet, while the placebo capsules contain inactive ingredients. This design allows comparison of the drug against placebo and later observation of dotinurads effects. During the study, participants will have their serum uric acid measured at various points, especially at weeks 16, 20, 24, and up to week 40. Researchers will monitor treatment-emergent adverse events throughout the study period. Participants will be followed from screening through treatment and safety assessments, with the primary focus on uric acid levels at week 24. The total study duration for each participant covers screening and up to 40 weeks of follow-up.

A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants