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

January 27, 2025 updated by: Arthrosi Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 1023
        • Arthrosi Investigative Site (201)
  • Taiwan
      • Taichung, Taiwan, 402
        • Arthrosi Investigative Site (303)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Arthrosi Investigative Site (410)
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arthrosi Investigative Site (403)
      • Sun City, Arizona, United States, 85351
        • Arthrosi Investigative Site (416)
      • Tucson, Arizona, United States, 85704
        • Arthrosi Investigative Site (417)
    • Florida
      • Tampa, Florida, United States, 33606
        • Arthrosi Investigative Site (402)
    • Idaho
      • Boise, Idaho, United States, 83713
        • Arthrosi Investigative Site (404)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Arthrosi Investigative Site (409)
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
        • Arthrosi Investigative Site (406)
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29577
        • Arthrosi Investigative Site (408)
    • Texas
      • Dallas, Texas, United States, 75231
        • Arthrosi Investigative Site (401)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Allopurinol once daily for 24 weeks
Drug: Allopurinol Tablet
Solid tablet
Experimental: Group 2
AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks
Drug: AR882 Dose 1
Solid Oral Capsule
Drug: AR882 Dose 2
Solid Oral Capsule
Experimental: Group 3
AR882 Dose 1 + Allopurinol for 24 weeks
Drug: Allopurinol Tablet
Solid tablet
Drug: AR882 Dose 1
Solid Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks and 24 weeks
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.
24 weeks
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
12 weeks
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
24 weeks
Incidence of Adverse Events
Time Frame: 24 weeks
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrosi Therapeutics

Investigators

  • Study Chair: R Keenan, MD, Arthrosi Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Actual)

August 13, 2024

Study Completion (Actual)

October 28, 2024

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR882-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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