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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04155918




Registration number
NCT04155918
Ethics application status
Date submitted
25/10/2019
Date registered
7/11/2019
Date last updated
19/11/2020

Titles & IDs
Public title
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
Scientific 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
Secondary ID [1] 0 0
AR882-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout Patients 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
Treatment: Drugs - Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)

Experimental: AR882/FBX -

Experimental: AR882/ALLO -


Treatment: Drugs: Group 1: AR882 Alone and in Combination with Febuxostat (FBX)
AR882 + Febuxostat, AR882 alone, Febuxostat alone

Treatment: Drugs: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PD profile of AR882 administered alone or in combination with febuxostat
Timepoint [1] 0 0
22 Days
Primary outcome [2] 0 0
PD profile of AR882 administered alone or in combination with allopurinol
Timepoint [2] 0 0
22 Days
Primary outcome [3] 0 0
Serum uric acid (sUA) response rate
Timepoint [3] 0 0
22 Days
Secondary outcome [1] 0 0
Area under the curve (AUC) for plasma AR882
Timepoint [1] 0 0
22 Days
Secondary outcome [2] 0 0
Time to maximum plasma concentration (Tmax) for AR882
Timepoint [2] 0 0
22 Days
Secondary outcome [3] 0 0
Maximum plasma concentration (Cmax) for AR882
Timepoint [3] 0 0
22 Days
Secondary outcome [4] 0 0
Apparent terminal half-life (t1/2) for AR882
Timepoint [4] 0 0
22 Days
Secondary outcome [5] 0 0
Amount excreted (Ae) into urine for AR882
Timepoint [5] 0 0
22 Days
Secondary outcome [6] 0 0
Renal clearance (CLr) for AR882
Timepoint [6] 0 0
22 Days
Secondary outcome [7] 0 0
AUC for plasma for febuxostat
Timepoint [7] 0 0
22 Days
Secondary outcome [8] 0 0
Tmax for febuxostat
Timepoint [8] 0 0
22 Days
Secondary outcome [9] 0 0
Cmax for febuxostat
Timepoint [9] 0 0
22 Days
Secondary outcome [10] 0 0
t1/2 for febuxostat
Timepoint [10] 0 0
22 Days
Secondary outcome [11] 0 0
AUC for plasma allopurinol/oxypurinol
Timepoint [11] 0 0
22 Days
Secondary outcome [12] 0 0
Tmax for allopurinol/oxypurinol
Timepoint [12] 0 0
22 Days
Secondary outcome [13] 0 0
Cmax for allopurinol/oxypurinol
Timepoint [13] 0 0
22 Days
Secondary outcome [14] 0 0
t1/2 for for allopurinol/oxypurinol
Timepoint [14] 0 0
22 Days
Secondary outcome [15] 0 0
Ae in urine for allopurinol/oxypurinol
Timepoint [15] 0 0
22 Days
Secondary outcome [16] 0 0
CLr for allopurinol/oxypurinol
Timepoint [16] 0 0
22 Days
Secondary outcome [17] 0 0
AUC for plasma for colchicine
Timepoint [17] 0 0
22 Days
Secondary outcome [18] 0 0
Tmax for colchicine
Timepoint [18] 0 0
22 Days
Secondary outcome [19] 0 0
Cmax for colchicine
Timepoint [19] 0 0
22 Days
Secondary outcome [20] 0 0
t1/2 for for colchicine
Timepoint [20] 0 0
22 Days
Secondary outcome [21] 0 0
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
Timepoint [21] 0 0
28 Days

Eligibility
Key inclusion criteria
Key

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

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/09/2020
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arthrosi Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04155918
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Wynne, MBChB, Grad Dip Pharm Med
Address 0 0
Christchurch Clinical Studies Trust Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04155918