Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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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
Date last updated
19/09/2024

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:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
Active, not recruiting
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
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)

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 urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
Trial website
https://clinicaltrials.gov/study/NCT05253833
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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/study/NCT05253833