Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

Arthrosi Therapeutics

Status and phase: Completed; Phase 2

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

Treatments: Drug: Allopurinol Tablet; Drug: AR882 Dose 1; Drug: AR882 Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05253833

AR882-203

Details and patient eligibility

About

This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of gout
• at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
• Patients who are NOT on approved ULT must have sUA > 7 mg/dL
• Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Allopurinol once daily for 24 weeks

Treatment:

Drug: Allopurinol Tablet

Group 2

Experimental group

Description:

AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks

Treatment:

Drug: AR882 Dose 2

Drug: AR882 Dose 1

Group 3

Experimental group

Description:

AR882 Dose 1 + Allopurinol for 24 weeks

Treatment:

Drug: AR882 Dose 1

Drug: Allopurinol Tablet