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Clinical Trials in the EU / 2024-520206-19-00
Completed Phase III

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

2024-520206-19-00 · tracked via the Priya Life Science EU tracker
Sponsor
Crystalys Therapeutics Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Musculoskeletal Diseases
Decision date
23/10/2025
Enrollment target
65
Sites
Spain, Poland

Condition studied

Hyperuricemia associated with gout.

Investigational medicinal product(s)

DotinuradPlacebo capsules to match overencapsulated dotinurad tablets and overencapsulated allopurinol tablets contain microcrystalline cellulose in a gelatin capsule.ALLOPURINOLALLOPURINOLALLOPURINOLDotinurad 1mg

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-520206-19-00 on CTIS ↗ ← All trials in the EU