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Completed

NCT Number: NCT04155918

Phase 2a Study of AR882 Alone and 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.

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Key information

Conditions

Gout Patients Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Christchurch Clinical Studies Trust, Ltd (CCST)

Christchurch, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1: AR882 Alone and in Combination with Febuxostat (FBX)

Drug

AR882 + Febuxostat, AR882 alone, Febuxostat alone

Other names: Febuxostat (Adenuric®, Uloric®)

Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)

Drug

AR882 + Allopurinol, AR882 alone, Allopurinol alone

Other names: Allopurinol (Allosig®, Progout®, Zyloprim®)

Primary outcomes

  1. PD profile of AR882 administered alone or in combination with febuxostat

    Time frame: 22 Days

    Profile from serum uric acid concentration over time

  2. PD profile of AR882 administered alone or in combination with allopurinol

    Time frame: 22 Days

    Profile from serum uric acid concentration over time.

  3. Serum uric acid (sUA) response rate

    Time frame: 22 Days

    sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL

Secondary outcomes

  1. Area under the curve (AUC) for plasma AR882

    Time frame: 22 Days

    Profile from plasma in terms of AUC for AR882

  2. Time to maximum plasma concentration (Tmax) for AR882

    Time frame: 22 Days

    Profile from plasma in terms of Tmax for AR882

  3. Maximum plasma concentration (Cmax) for AR882

    Time frame: 22 Days

    Profile from plasma in terms of Cmax for AR882

  4. Apparent terminal half-life (t1/2) for AR882

    Time frame: 22 Days

    Profile from plasma in terms of t1/2 for AR882

  5. Amount excreted (Ae) into urine for AR882

    Time frame: 22 Days

    Profile from urine in terms of Ae for AR882

  6. Renal clearance (CLr) for AR882

    Time frame: 22 Days

    Profile from urine in terms of CLr for AR882

  7. AUC for plasma for febuxostat

    Time frame: 22 Days

    Profile from plasma in terms of AUC for febuxostat

  8. Tmax for febuxostat

    Time frame: 22 Days

    Profile from plasma in terms of Tmax for febuxostat

  9. Cmax for febuxostat

    Time frame: 22 Days

    Profile from plasma in terms of Cmax for febuxostat

  10. t1/2 for febuxostat

    Time frame: 22 Days

    Profile from plasma in terms of t1/2 for febuxostat

  11. AUC for plasma allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from plasma in terms of AUC for allopurinol/oxypurinol

  12. Tmax for allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from plasma in terms of Tmax for allopurinol/oxypurinol

  13. Cmax for allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from plasma in terms of Cmax for allopurinol/oxypurinol

  14. t1/2 for for allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from plasma in terms of t1/2 for allopurinol/oxypurinol

  15. Ae in urine for allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from urine in terms of Ae for allopurinol/oxypurinol

  16. CLr for allopurinol/oxypurinol

    Time frame: 22 Days

    Profile from urine in terms of CLr for allopurinol/oxypurinol

  17. AUC for plasma for colchicine

    Time frame: 22 Days

    Profile from plasma in terms of AUC for colchicine

  18. Tmax for colchicine

    Time frame: 22 Days

    Profile from plasma in terms of Tmax for colchicine

  19. Cmax for colchicine

    Time frame: 22 Days

    Profile from plasma in terms of Cmax for colchicine

  20. t1/2 for for colchicine

    Time frame: 22 Days

    Profile from plasma in terms of t1/2 for colchicine

  21. Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Arthrosi Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Nov 19, 2020

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.

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