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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05253833




Registration number
NCT05253833
Ethics application status
Date submitted
15/02/2022
Date registered
24/02/2022

Titles & IDs
Public title
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination with Allopurinol in Patients with Tophaceous Gout
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
Secondary ID [1] 0 0
AR882-203
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Change from baseline in tophus area at Months 3 and 6
Timepoint [1] 0 0
12 weeks and 24 weeks
Secondary outcome [2] 0 0
Change from baseline in tophus crystal volume at Months 6
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Incidence of Adverse Events
Timepoint [5] 0 0
24 weeks

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
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
* Pregnant or breastfeeding
* 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
Open (masking not used)
Who is / are masked / blinded?



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
12/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/10/2024
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taichung

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

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/NCT05253833