Evaluating AR882 for lowering uric acid in gout patients
A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout
This study is testing a new medication called AR882 to see if it can lower uric acid levels in people with gout who have had multiple flare-ups.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Arthrosi Therapeutics Industry-sponsored |
| Locations | 78 sites (Birmingham, Alabama and 77 other locations) |
| Trial ID | NCT06846515 on ClinicalTrials.gov |
What this trial studies
This phase 3 trial aims to evaluate the efficacy and safety of AR882, a medication designed to lower serum uric acid levels in patients with gout. Participants will receive either AR882 at doses of 50 mg or 75 mg, or a placebo, over a period of 12 months. The study will focus on patients who have experienced multiple gout flares and are either not on urate-lowering therapy or have specific serum uric acid levels while on therapy. The primary outcome will be the reduction in serum uric acid levels compared to the placebo group.
Who should consider this trial
Good fit: Ideal candidates include adults with a history of gout who have experienced at least two gout flares in the past year and meet specific serum uric acid criteria.
Not a fit: Patients with recent malignancies, those who are pregnant or breastfeeding, or individuals with a history of symptomatic kidney stones in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing gout and reducing flare-ups.
How similar studies have performed: Other studies have shown promise in lowering uric acid levels with similar approaches, but the specific efficacy of AR882 is being evaluated for the first time in this phase.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 77 other locations
- Arthrosi Investigative Site (620) — Birmingham, Alabama, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (616) — Huntsville, Alabama, United States (Recruiting)
- Arthrosi Investigative Site (629) — Chandler, Arizona, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (640) — Phoenix, Arizona, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (617) — Little Rock, Arkansas, United States (Recruiting)
- Arthrosi Investigative Site (614) — Garden Grove, California, United States (Recruiting)
- Arthrosi Investigative Site (618) — La Mesa, California, United States (Recruiting)
- Arthrosi Investigative Site (655) — La Palma, California, United States (Recruiting)
- Arthrosi Investigative Site (632) — Lincoln, California, United States (Recruiting)
- Arthrosi Investigative Site (605) — Lomita, California, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (675) — Long Beach, California, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (603) — Santa Monica, California, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (672) — Tarzana, California, United States (Recruiting)
- Arthrosi Investigative Site (656) — Thousand Oaks, California, United States (Recruiting)
- Arthrosi Investigative Site (630) — Tujunga, California, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (667) — Whittier, California, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (660) — Aurora, Colorado, United States (Recruiting)
- Arthrosi Investigative Site (669) — Colorado Springs, Colorado, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (612) — Fort Collins, Colorado, United States (Recruiting)
- Arthrosi Investigative Site (665) — Cooper City, Florida, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (613) — Jupiter, Florida, United States (Recruiting)
- Arthrosi Investigative Site (611) — Miami, Florida, United States (Recruiting)
- Arthrosi Investigative Site (644) — Miami, Florida, United States (Recruiting)
- Arthrosi Investigative Site (615) — Sanford, Florida, United States (Recruiting)
- Arthrosi Investigative Site (600) — Tampa, Florida, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (673) — Atlanta, Georgia, United States (Recruiting)
- Arthrosi Investigative Site (652) — Marietta, Georgia, United States (Recruiting)
- Arthrosi Investigative Site (658) — Honolulu, Hawaii, United States (Recruiting)
- Arthrosi Investigative Site (676) — Boise, Idaho, United States (Recruiting)
- Arthrosi Investigative Site (634) — Meridian, Idaho, United States (Recruiting)
- Arthrosi Investigative Site (657) — Chicago, Illinois, United States (Recruiting)
- Arthrosi Investigative Site (648) — Melrose Park, Illinois, United States (Recruiting)
- Arthrosi Investigative Site (678) — Indianapolis, Indiana, United States (Recruiting)
- Arthrosi Investigative Site (679) — Overland Park, Kansas, United States (Recruiting)
- Arthrosi Investigative Site (674) — Louisville, Kentucky, United States (Recruiting)
- Arthrosi Investigative Site (627) — Mandeville, Louisiana, United States (Recruiting)
- Arthrosi Investigative Site (650) — New Orleans, Louisiana, United States (Recruiting)
- Arthrosi Investigative Site (641) — Prairieville, Louisiana, United States (Recruiting)
- Arthrosi Investigative Site (662) — Oxon Hill, Maryland, United States (Recruiting)
- Arthrosi Investigative Site (653) — Rockville, Maryland, United States (Recruiting)
- Arthrosi Investigative Site (636) — Fall River, Massachusetts, United States (Recruiting)
- Arthrosi Investigative Site (622) — Bay City, Michigan, United States (Recruiting)
- Arthrosi Investigative Site (628) — Farmington Hills, Michigan, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (645) — Southfield, Michigan, United States (Recruiting)
- Arthrosi Investigative Site (633) — Gulfport, Mississippi, United States (Recruiting)
- Arthrosi Investigative Site (635) — Jackson, Mississippi, United States (Recruiting)
- Arthrosi Investigative Site (637) — Springfield, Missouri, United States (Not_yet_recruiting)
- Arthrosi Investigative Site (626) — Town and Country, Missouri, United States (Recruiting)
- Arthrosi Investigative Site (610) — Lincoln, Nebraska, United States (Recruiting)
- Arthrosi Investigative Site (651) — Omaha, Nebraska, United States (Recruiting)
+28 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Director Clinical Operations
- Email: AR882-301@Arthrosi.com
- Phone: +1 858-437-9123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.