A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous 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 tophaceous 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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year. 3. Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter. 4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit). 5. Female participants of childbearing potential must have a negative s…
Interventions
- DrugAllopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
- DrugDotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Locations (78)
- Alabama Clinical TherapeuticsBirmingham, Alabama
- G & L ResearchFoley, 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