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Active (not recruiting) Phase 3 NCT06439602

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

Phase 3 – large-scale trial before approval
Conditions: Gout Arthritis, Gouty Hyperuricemia Gout Chronic

Sponsor: Arthrosi Therapeutics

trial.available_in: БГ
Overview
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
Who can participate
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
Locations 5
Australia (1)
Arthrosi Investigative Site (202)
Botany , New South Wales
Hong Kong (1)
Arthrosi Investigative Site (500)
Hong Kong , Central
New Zealand (1)
Arthrosi Investigative Site (300)
Auckland , Auckland
Taiwan (1)
Arthrosi Investigative Site (405)
Hualien City , Taiwan
United States (1)
Arthrosi Investigative Site (106)
Foley , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
26.06.2024
Completion date
01.11.2026
Registry ID
NCT06439602
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.