Skip to main content
OpenTrials
Completed

NCT Number: NCT05119686

Phase 2b Evaluation of Efficacy and Safety of AR882 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.

Completed

Looking for future studies?

Notify Me

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, Melbourne, Camberwell, Australia

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
  • 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

Treatment and study plan

AR882 Dose 1

Drug

Solid Oral Capsule

AR882 Dose 2

Drug

Solid Oral Capsule

Placebo

Drug

Matching Solid Oral Capsule Placebo

Primary outcomes

  1. Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing

    Time frame: 6 weeks

    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

Secondary outcomes

  1. sUA levels < 5, < 4, and < 3 mg/dL

    Time frame: 6 weeks

    Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL

  2. Incidence of Adverse Events

    Time frame: 14 weeks

    Treatment Emergent Adverse Events and Serious Adverse Event incidence.

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 12 weeks

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.

  4. Time to observed Cmax (Tmax)

    Time frame: 12 weeks

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.

  5. Area under the plasma concentration-time curve (AUC)

    Time frame: 12 weeks

    Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
May 12, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.