Arthritis, Gouty, Gout, Gout Chronic, Hyperuricemia
Conditions
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 months
Interventions
DRUGAR882 50 mg
Solid Oral Capsule
DRUGAR882 75 mg
Solid Oral Capsule
DRUGPlacebo
Matching Solid Oral Capsule Placebo
Sponsors
Arthrosi Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* History of gout * Occurrence of ≥ 2 self-reported gout flares in the last 12 months * Body weight no less than 50 kg * Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL * Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min
Exclusion criteria
* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * Pregnant or breastfeeding * History of symptomatic kidney stones within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6 | 24 weeks | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in tophus burden by month 12 | 48 weeks | Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method |
| Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12 | 12 weeks | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12 |
| Change in tophus burden by month 6 | 24 weeks | Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 6, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 6 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method |
| Incidence of Adverse Events | 56 weeks | Treatment Emergent Adverse Events and Serious Adverse Event incidence |
Countries
Australia, Hong Kong, New Zealand, Taiwan, United States
Contacts
STUDY_DIRECTORRobert Keenan, MD
Arthrosi Therapeutics, Inc.
Outcome results
None listed