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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

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
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Mississippi
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Hong Kong
State/province [26] 0 0
Central
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland
Country [28] 0 0
New Zealand
State/province [28] 0 0
Hamilton
Country [29] 0 0
New Zealand
State/province [29] 0 0
Nelson
Country [30] 0 0
New Zealand
State/province [30] 0 0
Rotorua
Country [31] 0 0
Taiwan
State/province [31] 0 0
Kaohsiung City
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taichung
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taoyuan City

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
AR882-302@Arthrosi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06439602