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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/NCT05119686




Registration number
NCT05119686
Ethics application status
Date submitted
20/10/2021
Date registered
15/11/2021
Date last updated
12/05/2023

Titles & IDs
Public title
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
Scientific title
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Secondary ID [1] 0 0
AR882-202
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 - Placebo

Experimental: Group 1 - AR882 Dose 1 x 12 weeks

Experimental: Group 2 - AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks

Placebo Comparator: Group 3 - AR882 matching placebo x 12 weeks


Treatment: Drugs: AR882 Dose 1
Solid Oral Capsule

Treatment: Drugs: AR882 Dose 2
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 following 6 weeks of dosing
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
sUA levels < 5, < 4, and < 3 mg/dL
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Incidence of Adverse Events
Timepoint [2] 0 0
14 weeks
Secondary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Time to observed Cmax (Tmax)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [5] 0 0
12 weeks

Eligibility
Key inclusion criteria
- History of gout

- sUA > 7 mg/dL

- Estimated Glomerular Filtration Rate (eGFR) = 30 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

- History of cardiac abnormalities

- 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
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
16/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2022
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
CamberwellNSW
Recruitment hospital [1] 0 0
Arthrosi Investigative Site - Melbourne
Recruitment hospital [2] 0 0
Arthrosi investigative Site - Botany
Recruitment postcode(s) [1] 0 0
3124 - Melbourne
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taichung City
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taoyuan

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 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05119686
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05119686