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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155918
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Arthrosi Therapeutics

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE February 3, 2020
Actual Primary Completion Date September 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • PD profile of AR882 administered alone or in combination with febuxostat [ Time Frame: 22 Days ]
    Profile from serum uric acid concentration over time
  • PD profile of AR882 administered alone or in combination with allopurinol [ Time Frame: 22 Days ]
    Profile from serum uric acid concentration over time.
  • Serum uric acid (sUA) response rate [ Time Frame: 22 Days ]
    sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Area under the curve (AUC) for plasma AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for AR882
  • Time to maximum plasma concentration (Tmax) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for AR882
  • Maximum plasma concentration (Cmax) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for AR882
  • Apparent terminal half-life (t1/2) for AR882 [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for AR882
  • Amount excreted (Ae) into urine for AR882 [ Time Frame: 22 Days ]
    Profile from urine in terms of Ae for AR882
  • Renal clearance (CLr) for AR882 [ Time Frame: 22 Days ]
    Profile from urine in terms of CLr for AR882
  • AUC for plasma for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for febuxostat
  • Tmax for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for febuxostat
  • Cmax for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for febuxostat
  • t1/2 for febuxostat [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for febuxostat
  • AUC for plasma allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for allopurinol/oxypurinol
  • Tmax for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for allopurinol/oxypurinol
  • Cmax for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for allopurinol/oxypurinol
  • t1/2 for for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
  • Ae in urine for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from urine in terms of Ae for allopurinol/oxypurinol
  • CLr for allopurinol/oxypurinol [ Time Frame: 22 Days ]
    Profile from urine in terms of CLr for allopurinol/oxypurinol
  • AUC for plasma for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of AUC for colchicine
  • Tmax for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of Tmax for colchicine
  • Cmax for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of Cmax for colchicine
  • t1/2 for for colchicine [ Time Frame: 22 Days ]
    Profile from plasma in terms of t1/2 for colchicine
  • Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [ Time Frame: 28 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gout Patients
Intervention  ICMJE
  • Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
    AR882 + Febuxostat, AR882 alone, Febuxostat alone
    Other Name: Febuxostat (Adenuric®, Uloric®)
  • Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
    AR882 + Allopurinol, AR882 alone, Allopurinol alone
    Other Name: Allopurinol (Allosig®, Progout®, Zyloprim®)
Study Arms  ICMJE
  • Experimental: AR882/FBX
    Intervention: Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
  • Experimental: AR882/ALLO
    Intervention: Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2020)		 30
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)		 32
Actual Study Completion Date  ICMJE September 3, 2020
Actual Primary Completion Date September 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04155918
Other Study ID Numbers  ICMJE AR882-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arthrosi Therapeutics
Study Sponsor  ICMJE Arthrosi Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Wynne, MBChB, Grad Dip Pharm Med Christchurch Clinical Studies Trust Ltd
PRS Account Arthrosi Therapeutics
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP