Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients

A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients

The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.

Study Overview

• Status: Completed
• Conditions: Gout Patients
• Intervention / Treatment: Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX); Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand
    • Christchurch Clinical Studies Trust, Ltd (CCST)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• History of gout
• sUA > 7 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2

Key Exclusion Criteria:

• Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
• History of cardiac abnormalities
• Active peptic ulcer disease or active liver disease
• History of kidney stones
• Allergy or intolerance to colchicine, febuxostat, and allopurinol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR882/FBX	Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX); AR882 + Febuxostat, AR882 alone, Febuxostat alone; Other Names: Febuxostat (Adenuric®, Uloric®)
Experimental: AR882/ALLO	Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO); AR882 + Allopurinol, AR882 alone, Allopurinol alone; Other Names: Allopurinol (Allosig®, Progout®, Zyloprim®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD profile of AR882 administered alone or in combination with febuxostat	Profile from serum uric acid concentration over time	22 Days
PD profile of AR882 administered alone or in combination with allopurinol	Profile from serum uric acid concentration over time.	22 Days
Serum uric acid (sUA) response rate	sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL	22 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve (AUC) for plasma AR882	Profile from plasma in terms of AUC for AR882	22 Days
Time to maximum plasma concentration (Tmax) for AR882	Profile from plasma in terms of Tmax for AR882	22 Days
Maximum plasma concentration (Cmax) for AR882	Profile from plasma in terms of Cmax for AR882	22 Days
Apparent terminal half-life (t1/2) for AR882	Profile from plasma in terms of t1/2 for AR882	22 Days
Amount excreted (Ae) into urine for AR882	Profile from urine in terms of Ae for AR882	22 Days
Renal clearance (CLr) for AR882	Profile from urine in terms of CLr for AR882	22 Days
AUC for plasma for febuxostat	Profile from plasma in terms of AUC for febuxostat	22 Days
Tmax for febuxostat	Profile from plasma in terms of Tmax for febuxostat	22 Days
Cmax for febuxostat	Profile from plasma in terms of Cmax for febuxostat	22 Days
t1/2 for febuxostat	Profile from plasma in terms of t1/2 for febuxostat	22 Days
AUC for plasma allopurinol/oxypurinol	Profile from plasma in terms of AUC for allopurinol/oxypurinol	22 Days
Tmax for allopurinol/oxypurinol	Profile from plasma in terms of Tmax for allopurinol/oxypurinol	22 Days
Cmax for allopurinol/oxypurinol	Profile from plasma in terms of Cmax for allopurinol/oxypurinol	22 Days
t1/2 for for allopurinol/oxypurinol	Profile from plasma in terms of t1/2 for allopurinol/oxypurinol	22 Days
Ae in urine for allopurinol/oxypurinol	Profile from urine in terms of Ae for allopurinol/oxypurinol	22 Days
CLr for allopurinol/oxypurinol	Profile from urine in terms of CLr for allopurinol/oxypurinol	22 Days
AUC for plasma for colchicine	Profile from plasma in terms of AUC for colchicine	22 Days
Tmax for colchicine	Profile from plasma in terms of Tmax for colchicine	22 Days
Cmax for colchicine	Profile from plasma in terms of Cmax for colchicine	22 Days
t1/2 for for colchicine	Profile from plasma in terms of t1/2 for colchicine	22 Days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs		28 Days

Collaborators and Investigators

• Sponsor: Arthrosi Therapeutics
• Investigators: Principal Investigator: Christopher Wynne, MBChB, Grad Dip Pharm Med, Christchurch Clinical Studies Trust Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): September 3, 2020
• Study Completion (Actual): September 3, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Gout; Hyperuricemia; URAT1
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol; Febuxostat
• Other Study ID Numbers: AR882-201

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.: Yes