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Dotinurad vs Allopurinol in Gout
NCT07089875Phase 3
Key facts
- Status
- Recruiting
- Start
- Aug 2025
- Primary completion
- Nov 2027
- Countries
- 3
- Sponsor
- Crystalys Therapeutics
- Modality
- Small Molecules
- Drugs
- dotinurad
- Conditions
- gouthyperuricemia
01
Overview
Phase 3, randomised, double-blind trial of dotinurad in gout and hyperuricemia (3 arms), sponsored by Crystalys Therapeutics. Primary endpoint: Percentage of Participants With an sUA Level <6.0 mg/dL at 24 weeks. Started Aug 2025; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Allopurinol
Participants continue allopurinol at the same dose once a day through Week 64.
Dotinurad 2 mg Maintenance
Dotinurad 1 mg QD for Weeks 1-4, then 2 mg QD through Week 64.
Dotinurad 4 mg Maintenance
Dotinurad 1 mg QD for Weeks 1-4, 2 mg QD for Weeks 5-12, and 4 mg QD thereafter through Week 64.
03
Who it enrols
Adults aged 18-75 with gout and hyperuricemia (sUA >=6.5 mg/dL) who have had at least 2 gout flares in the past year and are on a stable background dose of allopurinol.
04
Endpoints
Primary
Percentage of Participants With an sUA Level <6.0 mg/dL
Secondary
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Mean Rate of Gout Flares Requiring Treatment
Percentage 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
Mean Change From Baseline in sUA
Percentage of Participants who do not Have a Gout Flare Requiring Treatment
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit
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