Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout; Arthritis, Gouty; Gout Chronic
• Intervention / Treatment: Drug: AR882 Dose 1; Drug: AR882 Dose 2; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Camberwell
    • Melbourne, Camberwell, Australia, 3124
      • Arthrosi Investigative Site
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Arthrosi Investigative Site
• Taiwan
  • Taichung City, Taiwan, 402
    • Arthrosi Investigative Site
  • Taipei City, Taiwan, 112
    • Arthrosi Investigative Site - 301
  • Taipei City, Taiwan, 112
    • Arthrosi Investigative Site - 304
  • Taipei City, Taiwan, 114
    • Arthrosi Investigative Site
  • Taoyuan, Taiwan, 333
    • Arthrosi Investigative Site
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Arthrosi Investigative Site
    • Sun City, Arizona, United States, 85351
      • Arthrosi Investigative Site
    • Tucson, Arizona, United States, 85704
      • Arthrosi Investigative Site
  • Florida
    • Miami, Florida, United States, 33143
      • Arthrosi Investigative Site
    • Miami Lakes, Florida, United States, 33014
      • Arthrosi Investigative Site
    • Tampa, Florida, United States, 33613
      • Arthrosi Investigative Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Arthrosi Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Arthrosi Investigative Site
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Arthrosi Investigative Site
    • Cleveland, Ohio, United States, 44195
      • Arthrosi Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Arthrosi Investigative Site
  • Texas
    • Dallas, Texas, United States, 75231
      • Arthrosi Investigative Site
    • Houston, Texas, United States, 77074
      • Arthrosi Investigative Site
    • Tomball, Texas, United States, 77375
      • Arthrosi Investigative Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • Arthrosi Investigative Site
  • Wisconsin
    • Glendale, Wisconsin, United States, 53217
      • Arthrosi Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of gout
• sUA > 7 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; AR882 Dose 1 x 12 weeks	Drug: AR882 Dose 1; Solid Oral Capsule
Experimental: Group 2; AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks	Drug: AR882 Dose 1; Solid Oral Capsule; Drug: AR882 Dose 2; Solid Oral Capsule
Placebo Comparator: Group 3; AR882 matching placebo x 12 weeks	Drug: Placebo; Matching Solid Oral Capsule Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sUA levels < 5, < 4, and < 3 mg/dL	Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL	6 weeks
Incidence of Adverse Events	Treatment Emergent Adverse Events and Serious Adverse Event incidence.	14 weeks
Maximum Observed Plasma Concentration (Cmax)	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.	12 weeks
Time to observed Cmax (Tmax)	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.	12 weeks
Area under the plasma concentration-time curve (AUC)	Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.	12 weeks

Collaborators and Investigators

• Sponsor: Arthrosi Therapeutics
• Investigators: Study Chair: R Keenan, MD, Arthrosi Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): November 17, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Arthritis, Gouty
• Other Study ID Numbers: AR882-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No