Trials / Recruiting
RecruitingNCT07089875
A Study of Dotinurad Versus Allopurinol in Participants With Gout
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Crystalys Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Allopurinol | Over-encapsulated tablets containing active drug substance administered orally (PO). |
| DRUG | Dotinurad | Over-encapsulated tablets containing active drug substance administered PO. |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2027-11-29
- Completion
- 2027-11-29
- First posted
- 2025-07-28
- Last updated
- 2026-03-12
Locations
95 sites across 3 countries: United States, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07089875. Inclusion in this directory is not an endorsement.