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Anti-hyperuricemic agent
AR882 for Gout
Phase 3
Recruiting
Research Sponsored by Arthrosi Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine must be < 3.0 mg/dL and estimated creatinine clearance (CLcr) ≥ 30 mL/min
Patients who are on medically appropriate ULT must have serum uric acid (sUA) level > 6 mg/dL
Must not have
Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
History of symptomatic kidney stones within the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights
Pivotal Trial
Summary
This trial will test the effects and safety of AR882 on lowering serum uric acid levels in gout patients. They will compare two different doses of AR882 to a placebo over a period of
Who is the study for?
This trial is for individuals with gout, characterized by high uric acid levels. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific range of uric acid levels.
What is being tested?
The study is testing the effectiveness and safety of AR882 in reducing serum uric acid in gout patients. Two different doses of AR882 (50 mg and 75 mg) will be compared against a placebo over the course of 12 months.
What are the potential side effects?
While specific side effects are not listed, common ones associated with medications like AR882 could include stomach pain, kidney issues, rash or allergic reactions. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range.
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My uric acid level is above 6 mg/dL despite being on treatment.
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I have had gout before.
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My uric acid level is 7 mg/dL or higher and I am not on urate-lowering therapy.
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I have had 2 or more gout attacks in the past year.
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My body weight is at least 50 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer in the last 5 years, except for skin cancer that was treated successfully.
Select...
I have had painful kidney stones in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
Secondary study objectives
Change in tophus burden by month 12
Incidence of Adverse Events
Monthly mean rate of gout flares by month 12
+2 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: AR882 75 mgExperimental Treatment1 Intervention
AR882 75 mg taken once daily for 12 months
Group II: AR882 50 mgExperimental Treatment1 Intervention
AR882 50 mg taken once daily for 12 months
Group III: PlaceboPlacebo Group1 Intervention
AR882 matching placebo taken once daily for 12 months
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Who is running the clinical trial?
Arthrosi TherapeuticsLead Sponsor
7 Previous Clinical Trials
358 Total Patients Enrolled
3 Trials studying Gout
212 Patients Enrolled for Gout
Robert Keenan, MDStudy DirectorArthrosi Therapeutics, Inc.