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
Crystalys Therapeutics
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent. 2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year. 3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records). 4. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening a…
Interventions
- DrugAllopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
- DrugDotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Locations (95)
- University of Alabama at BirminghamBirmingham, Alabama
- Alabama Clinical TherapeuticsBirmingham, Alabama
- Arizona Arthritis & Rheumatology Associates (AARA) - GilbertGilbert, Arizona
- Arizona Arthritis & Rheumatology Associates (AARA) - GlendaleGlendale, Arizona
- Arizona Arthritis & Rheumatology Associates (AARA) - MesaMesa, Arizona
- Del Sol Research Management - Tucson EastTucson, Arizona