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

NCT05253833 | Completed Phase 2 FDA Drug

• 1 other identifier: AR882-203
• Study Type: interventional
• Target: 42
• Locations: 3 countries
• Sites: 12

Brief Summary

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.

Conditions

Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Secondary Outcomes (5)

• Change from baseline in tophus area at Months 3 and 6

  12 weeks and 24 weeks

• Change from baseline in tophus crystal volume at Months 6

  24 weeks

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

  12 weeks

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

  24 weeks

• Incidence of Adverse Events

  24 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Allopurinol once daily for 24 weeks

Drug: Allopurinol Tablet

Group 2

EXPERIMENTAL

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

Drug: AR882 Dose 1; Drug: AR882 Dose 2

Group 3

EXPERIMENTAL

AR882 Dose 1 + Allopurinol for 24 weeks

Drug: AR882 Dose 1; Drug: Allopurinol Tablet

Interventions

AR882 Dose 1 DRUG

Solid Oral Capsule

Group 2; Group 3

AR882 Dose 2 DRUG

Solid Oral Capsule

Group 2

Allopurinol Tablet DRUG

Solid tablet

Group 1; Group 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Arthrosi Therapeutics: lead

Study Sites (12)

Arthrosi Investigative Site (410)

Birmingham, Alabama, 35233, United States

Location

Arthrosi Investigative Site (403)

Phoenix, Arizona, 85032, United States

Location

Arthrosi Investigative Site (416)

Sun City, Arizona, 85351, United States

Location

Arthrosi Investigative Site (417)

Tucson, Arizona, 85704, United States

Location

Arthrosi Investigative Site (402)

Tampa, Florida, 33606, United States

Location

Arthrosi Investigative Site (404)

Boise, Idaho, 83713, United States

Location

Arthrosi Investigative Site (409)

Ann Arbor, Michigan, 48109, United States

Location

Arthrosi Investigative Site (406)

Greensboro, North Carolina, 27410, United States

Location

Arthrosi Investigative Site (408)

Myrtle Beach, South Carolina, 29577, United States

Location

Arthrosi Investigative Site (401)

Dallas, Texas, 75231, United States

Location

Arthrosi Investigative Site (201)

Auckland, 1023, New Zealand

Location

Arthrosi Investigative Site (303)

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Gout; Arthritis, Gouty; Hyperuricemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• R Keenan, MD

  Arthrosi Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: August 12, 2022
• Primary Completion: August 13, 2024
• Study Completion: October 28, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (10); NZ (1); TW (1)