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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
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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
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Secondary ID [1]
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AR882-203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout
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Arthritis, Gouty
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Hyperuricemia
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Gout Chronic
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Renal and Urogenital
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0
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Other renal and urogenital disorders
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Metabolic and Endocrine
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
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Assessment method [1]
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Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Change from baseline in tophus area at Months 3 and 6
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Assessment method [1]
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Comparison of the treatment groups for tophus area as measured by digital calipers
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Timepoint [1]
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12 weeks and 24 weeks
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Secondary outcome [2]
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Change from baseline in tophus crystal volume at Months 6
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Assessment method [2]
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Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
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Assessment method [3]
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Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
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Assessment method [4]
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Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Incidence of Adverse Events
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Assessment method [5]
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Treatment Emergent Adverse Events and Serious Adverse Event incidence.
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Timepoint [5]
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24 weeks
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Idaho
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Country [5]
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United States of America
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State/province [5]
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Michigan
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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South Carolina
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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New Zealand
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State/province [9]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arthrosi Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05253833
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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R Keenan, MD
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Address
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Arthrosi Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05253833
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