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

Arthrosi Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Gout Chronic; Arthritis, Gouty; Hyperuricemia; Gout

Treatments: Drug: AR882 75 mg; Drug: Placebo; Drug: AR882 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06439602

AR882-302

Details and patient eligibility

About

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

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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750 participants in 3 patient groups, including a placebo group

AR882 50 mg

Experimental group

Description:

AR882 50 mg taken once daily for 12 months

Treatment:

Drug: AR882 50 mg

AR882 75 mg

Experimental group

Description:

AR882 75 mg taken once daily for 12 months

Treatment:

Drug: AR882 75 mg

Placebo

Placebo Comparator group

Description:

AR882 matching placebo taken once daily for 12 months

Treatment:

Drug: Placebo