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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05253833




Registration number
NCT05253833
Ethics application status
Date submitted
15/02/2022
Date registered
24/02/2022
Date last updated
14/02/2024

Titles & IDs
Public title
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Scientific title
A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
Secondary ID [1] 0 0
AR882-203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Arthritis, Gouty 0 0
Hyperuricemia 0 0
Gout Chronic 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
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AR882 Dose 1
Treatment: Drugs - AR882 Dose 2
Treatment: Drugs - Allopurinol Tablet

Active Comparator: Group 1 - Allopurinol once daily for 24 weeks

Experimental: Group 2 - AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks

Experimental: Group 3 - AR882 Dose 1 + Allopurinol for 24 weeks


Treatment: Drugs: AR882 Dose 1
Solid Oral Capsule

Treatment: Drugs: AR882 Dose 2
Solid Oral Capsule

Treatment: Drugs: Allopurinol Tablet
Solid tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Change from baseline in tophus area at Months 3 and 6
Timepoint [1] 0 0
12 weeks and 24 weeks
Secondary outcome [2] 0 0
Change from baseline in tophus crystal volume at Months 6
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Incidence of Adverse Events
Timepoint [5] 0 0
24 weeks

Eligibility
Key inclusion criteria
- History of gout

- at least 1 measurable tophus on the hands/wrists and/or feet/ankles = 5 mm and = 30 mm
in the longest diameter.

- Patients who are NOT on approved ULT must have sUA > 7 mg/dL

- Patients who are on medically appropriate ULT must have sUA > 6 mg/dL

- Estimated Glomerular Filtration Rate (eGFR) = 45 mL/min/1.73m2
Minimum age
18 Years
Maximum age
75 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

- Pregnant or breastfeeding

- History of kidney stones

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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882
alone and in combination with allopurinol in patients with tophaceous gout at two doses
compared to allopurinol over 24 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05253833
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
R Keenan, MD
Address 0 0
Arthrosi Therapeutics
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