Trial Review

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Trial details imported from ClinicalTrials.gov

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

No information has been provided regarding IPD availability


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/NCT05119686