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Completed

NCT Number: NCT05253833

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

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.

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Key information

Conditions

Gout Arthritis Arthritis, Gouty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Chronic Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arthrosi Investigative Site (201), Auckland, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AR882 Dose 1

Drug

Solid Oral Capsule

AR882 Dose 2

Drug

Solid Oral Capsule

Allopurinol Tablet

Drug

Solid tablet

Primary outcomes

  1. Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3

    Time frame: 12 weeks

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3

Secondary outcomes

  1. Change from baseline in tophus area at Months 3 and 6

    Time frame: 12 weeks and 24 weeks

    Comparison of the treatment groups for tophus area as measured by digital calipers

  2. Change from baseline in tophus crystal volume at Months 6

    Time frame: 24 weeks

    Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.

  3. Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3

    Time frame: 12 weeks

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3

  4. Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6

    Time frame: 24 weeks

    Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6

  5. Incidence of Adverse Events

    Time frame: 24 weeks

    Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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