Clinical trial NCT06846515: Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
Official title: A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gout
Arthritis, Gouty
Hyperuricemia
Gout Chronic
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-02-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in tophus burden by month 12
timeFrame: 48 weeks
measure: Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12
timeFrame: 12 weeks
measure: No gout flares from the end of month 9 to the end of month 12
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arthrosi Investigative Site (620)
state: Alabama
city: Huntsville
country: United States
facility: Arthrosi Investigative Site (616)
state: Alabama
city: Chandler
country: United States
facility: Arthrosi Investigative Site (629)
state: Arizona
city: Peoria
country: United States
facility: Arthrosi Investigative Site (680)
state: Arizona
city: Phoenix
country: United States
facility: Arthrosi Investigative Site (640)
state: Arizona
city: Little Rock
country: United States
facility: Arthrosi Investigative Site (617)
state: Arkansas
city: Garden Grove
country: United States
facility: Arthrosi Investigative Site (614)
state: California
city: La Mesa
country: United States
facility: Arthrosi Investigative Site (618)
state: California
city: La Palma
country: United States
facility: Arthrosi Investigative Site (655)
state: California
city: Lincoln
country: United States
facility: Arthrosi Investigative Site (632)
state: California
city: Lomita
country: United States
facility: Arthrosi Investigative Site (605)
state: California
city: Long Beach
country: United States
facility: Arthrosi Investigative Site (675)
state: California
city: Santa Monica
country: United States
facility: Arthrosi Investigative Site (603)
state: California
city: Tarzana
country: United States
facility: Arthrosi Investigative Site (672)
state: California
city: Thousand Oaks
country: United States
facility: Arthrosi Investigative Site (656)
state: California
city: Tujunga
country: United States
facility: Arthrosi Investigative Site (630)
state: California
city: Whittier
country: United States
facility: Arthrosi Investigative Site (667)
state: California
city: Aurora
country: United States
facility: Arthrosi Investigative Site (660)
state: Colorado
city: Colorado Springs
country: United States
facility: Arthrosi Investigative Site (669)
state: Colorado
city: Fort Collins
country: United States
facility: Arthrosi Investigative Site (612)
state: Colorado
city: Cooper City
country: United States
facility: Arthrosi Investigative Site (665)
state: Florida
city: Jupiter
country: United States
facility: Arthrosi Investigative Site (613)
state: Florida
city: Miami
country: United States
facility: Arthrosi Investigative Site (611)
state: Florida
city: Miami
country: United States
facility: Arthrosi Investigative Site (644)
state: Florida
city: Sanford
country: United States
facility: Arthrosi Investigative Site (615)
state: Florida
city: Tampa
country: United States
facility: Arthrosi Investigative Site (600)
state: Florida
city: Atlanta
country: United States
facility: Arthrosi Investigative Site (673)
state: Georgia
city: Lilburn
country: United States
facility: Arthrosi Investigative Site (682)
state: Georgia
city: Marietta
country: United States
facility: Arthrosi Investigative Site (652)
state: Georgia
city: Honolulu
country: United States
facility: Arthrosi Investigative Site (658)
state: Hawaii
city: Boise
country: United States
facility: Arthrosi Investigative Site (676)
state: Idaho
city: Meridian
country: United States
facility: Arthrosi Investigative Site (634)
state: Idaho
city: Chicago
country: United States
facility: Arthrosi Investigative Site (657)
state: Illinois
city: Melrose Park
country: United States
facility: Arthrosi Investigative Site (648)
state: Illinois
city: Indianapolis
country: United States
facility: Arthrosi Investigative Site (678)
state: Indiana
city: Overland Park
country: United States
facility: Arthrosi Investigative Site (679)
state: Kansas
city: Louisville
country: United States
facility: Arthrosi Investigative Site (674)
state: Kentucky
city: Mandeville
country: United States
facility: Arthrosi Investigative Site (627)
state: Louisiana
city: New Orleans
country: United States
facility: Arthrosi Investigative Site (650)
state: Louisiana
city: Prairieville
country: United States
facility: Arthrosi Investigative Site (641)
state: Louisiana
city: Oxon Hill
country: United States
facility: Arthrosi Investigative Site (662)
state: Maryland
city: Rockville
country: United States
facility: Arthrosi Investigative Site (653)
state: Maryland
city: Fall River
country: United States
facility: Arthrosi Investigative Site (636)
state: Massachusetts
city: Bay City
country: United States
facility: Arthrosi Investigative Site (622)
state: Michigan
city: Farmington Hills
country: United States
facility: Arthrosi Investigative Site (628)
state: Michigan
city: Southfield
country: United States
facility: Arthrosi Investigative Site (645)
state: Michigan
city: Gulfport
country: United States
facility: Arthrosi Investigative Site (633)
state: Mississippi
city: Jackson
country: United States
facility: Arthrosi Investigative Site (635)
state: Mississippi
city: Springfield
country: United States
facility: Arthrosi Investigative Site (637)
state: Missouri
city: Town and Country
country: United States
facility: Arthrosi Investigative Site (626)
state: Missouri
city: Missoula
country: United States
facility: Arthrosi Investigative Site (664)
state: Montana
city: Lincoln
country: United States
facility: Arthrosi Investigative Site (610)
state: Nebraska
city: Omaha
country: United States
facility: Arthrosi Investigative Site (684)
state: Nebraska
city: Omaha
country: United States
facility: Arthrosi Investigative Site (651)
state: Nebraska
city: Brooklyn
country: United States
facility: Arthrosi Investigative Site (661)
state: New York
city: Hartsdale
country: United States
facility: Arthrosi Investigative Site (663)
state: New York
city: Charlotte
country: United States
facility: Arthrosi Investigative Site (625)
state: North Carolina
city: Charlotte
country: United States
facility: Arthrosi Investigative Site (681)
state: North Carolina
city: Raleigh
country: United States
facility: Arthrosi Investigative Site (683)
state: North Carolina
city: Shelby
country: United States
facility: Arthrosi Investigative Site (649)
state: North Carolina
city: Fargo
country: United States
facility: Arthrosi Investigative Site (666)
state: North Dakota
city: Mason
country: United States
facility: Arthrosi Investigative Site (671)
state: Ohio
city: Norman,
country: United States
facility: Arthrosi Investigative Site (631)
state: Oklahoma
city: Tulsa
country: United States
facility: Arthrosi Investigative Site (642)
state: Oklahoma
city: Horsham
country: United States
facility: Arthrosi Investigative Site (647)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthrosi Investigative Site (623)
state: Pennsylvania
city: Charlston
country: United States
facility: Arthrosi Investigative Site (638)
state: South Carolina
city: Fort Mill
country: United States
facility: Arthrosi Investigative Site (604)
state: South Carolina
city: North Charleston
country: United States
facility: Arthrosi Investigative Site (608)
state: South Carolina
city: Chattanooga
country: United States
facility: Arthrosi Investigative Site (619)
state: Tennessee
city: Hendersonville
country: United States
facility: Arthrosi Investigative Site (624)
state: Tennessee
city: Amarillo
country: United States
facility: Arthrosi Investigative Site (670)
state: Texas
city: Austin
country: United States
facility: Arthrosi Investigative Site (677)
state: Texas
city: DeSoto
country: United States
facility: Arthrosi Investigative Site (639)
state: Texas
city: Houston
country: United States
facility: Arthrosi Investigative Site (601)
state: Texas
city: Prosper
country: United States
facility: Arthrosi Investigative Site (689)
state: Texas
city: Sugar Land
country: United States
facility: Arthrosi Investigative Site (607)
state: Texas
city: Tomball
country: United States
facility: Arthrosi Investigative Site (646)
state: Texas
city: Tomball
country: United States
facility: Arthrosi Investigative Site (659)
state: Texas
city: Clinton
country: United States
facility: Arthrosi Investigative Site (643)
state: Utah
city: Salt Lake City
country: United States
facility: Arthrosi Investigative Site (609)
state: Utah
city: Salt Lake City
country: United States
facility: Arthrosi Investigative Site (654)
state: Utah
city: Charlottesville
country: United States
facility: Arthrosi Investigative Site (606)
state: Virginia
city: Bellevue
country: United States
facility: Arthrosi Investigative Site (685)
state: Washington
city: Kenosha
country: United States
facility: Arthrosi Investigative Site (668)
state: Wisconsin
Study officials:
affiliation: Arthrosi Therapeutics, Inc.
name: Robert Keenan, MD
role: STUDY_DIRECTOR
References: