A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

AR882-302

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

2024-06-01

2026-11-01

2026-11-01

Recruiting

Early phase I

750

Inclusion Criteria: * History of gout * Occurrence of ≥ 2 self-reported gout flares in the last 12 months * Body weight no less than 50 kg * Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL * Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min Exclusion Criteria: * Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * Pregnant or breastfeeding * History of symptomatic kidney stones within the past 6 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}

2024-06-03