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

Last updated: January 27, 2025
Sponsor: Arthrosi Therapeutics
Overall Status: Completed

Phase

2

Condition

Collagen Vascular Diseases

Musculoskeletal Diseases

Gout (Hyperuricemia)

Treatment

AR882 Dose 2

Allopurinol Tablet

AR882 Dose 1

Clinical Study ID

NCT05253833
AR882-203
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of gout

  • at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30mm 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

Exclusion Criteria:

  • Malignancy within 5 years, except for successfully treated basal or squamous cellcarcinoma of the skin

  • Pregnant or breastfeeding

  • History of kidney stones

Study Design

Total Participants: 42
Treatment Group(s): 3
Primary Treatment: AR882 Dose 2
Phase: 2
Study Start date:
August 12, 2022
Estimated Completion Date:
October 28, 2024

Connect with a study center

  • Arthrosi Investigative Site (201)

    Auckland, 1023
    New Zealand

    Site Not Available

  • Arthrosi Investigative Site (303)

    Taichung, 402
    Taiwan

    Site Not Available

  • Arthrosi Investigative Site (410)

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Arthrosi Investigative Site (403)

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arthrosi Investigative Site (416)

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Arthrosi Investigative Site (417)

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arthrosi Investigative Site (402)

    Tampa, Florida 33606
    United States

    Site Not Available

  • Arthrosi Investigative Site (404)

    Boise, Idaho 83713
    United States

    Site Not Available

  • Arthrosi Investigative Site (409)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Arthrosi Investigative Site (406)

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Arthrosi Investigative Site (408)

    Myrtle Beach, South Carolina 29577
    United States

    Site Not Available

  • Arthrosi Investigative Site (401)

    Dallas, Texas 75231
    United States

    Site Not Available

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