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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06439602




Registration number
NCT06439602
Ethics application status
Date submitted
28/05/2024
Date registered
3/06/2024
Date last updated
24/09/2024

Titles & IDs
Public title
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients
Scientific title
A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants with Gout
Secondary ID [1] 0 0
AR882-302
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 50 mg
Treatment: Drugs - AR882 75 mg
Treatment: Drugs - Placebo

Experimental: AR882 50 mg - AR882 50 mg taken once daily for 12 months

Experimental: AR882 75 mg - AR882 75 mg taken once daily for 12 months

Placebo comparator: Placebo - AR882 matching placebo taken once daily for 12 months


Treatment: Drugs: AR882 50 mg
Solid Oral Capsule

Treatment: Drugs: AR882 75 mg
Solid Oral Capsule

Treatment: Drugs: Placebo
Matching Solid Oral Capsule Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
No gout flares from the end of month 9 to the end of month 12
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Monthly mean rate of gout flares by month 12
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Change in tophus burden by month 12
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
Incidence of Adverse Events
Timepoint [5] 0 0
56 weeks

Eligibility
Key inclusion criteria
* History of gout
* Occurrence of = 2 self-reported gout flares in the last 12 months
* Body weight no less than 50 kg
* Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA = 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA > 6 mg/dL
* Serum creatinine must be < 3.0 mg/dL and estimated CLcr = 30 mL/min
Minimum age
18 Years
Maximum age
85 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 symptomatic kidney stones within the past 6 months

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Arthrosi Investigative Site (203) - Botany
Recruitment hospital [2] 0 0
Arthrosi Investigative Site (201) - Westmead
Recruitment hospital [3] 0 0
Arthrosi Investigative Site (200) - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
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
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
South Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
New Zealand
State/province [23] 0 0
Auckland
Country [24] 0 0
New Zealand
State/province [24] 0 0
Hamilton
Country [25] 0 0
New Zealand
State/province [25] 0 0
Nelson
Country [26] 0 0
New Zealand
State/province [26] 0 0
Rotorua

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 uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
Trial website
https://clinicaltrials.gov/study/NCT06439602
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Keenan, MD
Address 0 0
Arthrosi Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+1 858-437-9123
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06439602