A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520206-19-00

Acronym

FYU-981-CRYS-301

Enrollment

Registered

2025-10-23

Start date

2025-12-02

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia associated with gout.

Brief summary

1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.

Detailed description

1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive., 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64., 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.

Interventions

DRUGALLOPURINOL

DRUGDotinurad

DRUGPlacebo capsules to match overencapsulated dotinurad tablets and overencapsulated allopurinol tablets contain microcrystalline cellulose in a gelatin capsule.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.	—

Secondary

Measure	Time frame
1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive., 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64., 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026