Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

Arthrosi Therapeutics

Status and phase: Completed; Phase 2

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

Treatments: Drug: AR882 Dose 1; Drug: Placebo; Drug: AR882 Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05119686

AR882-202

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 weeks.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of gout
• sUA > 7 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion criteria

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• History of cardiac abnormalities
• History of kidney stones

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

AR882 Dose 1 x 12 weeks

Treatment:

Drug: AR882 Dose 1

Group 2

Experimental group

Description:

AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks

Treatment:

Drug: AR882 Dose 2

Drug: AR882 Dose 1

Group 3

Placebo Comparator group

Description:

AR882 matching placebo x 12 weeks

Treatment:

Drug: Placebo