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

Phase 2

Completed

• Conditions: Hyperuricemia; Gout Chronic; Gout; Arthritis, Gouty
• Interventions: Drug: AR882 Dose 1; Drug: Placebo; Drug: AR882 Dose 2

• Registration Number: NCT05119686
• Lead Sponsor: Arthrosi Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-15
• Study Start: 2021-11-16
• Primary Completion: 2022-11-17
• Study Completion: 2022-11-17
• Status Verified: 2023-05
• Disposition First Submitted: 2023-05-06
• Last Update Submitted: 2023-05-06
• Disposition First Posted: 2023-05-12
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	AR882 Dose 1	AR882 Dose 1 x 12 weeks
Group 2	AR882 Dose 1	AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
Group 2	AR882 Dose 2	AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks
Group 3	Placebo	AR882 matching placebo x 12 weeks

Primary Outcome Measures

Name	Time	Method
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing	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 Outcome Measures

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

Trial Locations

Locations (4)

Arthrosi Investigative Site - 301; 🇨🇳 Taipei City, Taiwan

Arthrosi Investigative Site - 304; 🇨🇳 Taipei City, Taiwan

Arthrosi investigative Site; 🇦🇺 Botany, New South Wales, Australia

Arthrosi Investigative Site; 🇨🇳 Taoyuan, Taiwan