Trials / Not Yet Recruiting
Not Yet RecruitingNCT07535034
A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Crystalys Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dotinurad | Over-encapsulated tablets containing active drug substance administered orally. |
| OTHER | Placebo | Capsules containing microcrystalline cellulose administered orally. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-07-01
- Completion
- 2027-08-01
- First posted
- 2026-04-16
- Last updated
- 2026-04-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07535034. Inclusion in this directory is not an endorsement.