Clinical trial NCT06439602: Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
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: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gout
Arthritis, Gouty
Hyperuricemia
Gout Chronic
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-03
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: 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: Change in tophus burden by month 12
timeFrame: 48 weeks
measure: Incidence of Adverse Events
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Foley
country: United States
facility: Arthrosi Investigative Site (106)
state: Alabama
city: Anchorage
country: United States
facility: Arthrosi Investigative Site (139)
state: Alaska
city: Peoria
country: United States
facility: Arthrosi Investigative Site (160)
state: Arizona
city: Phoenix
country: United States
facility: Arthrosi Investigative Site (112)
state: Arizona
city: Tempe
country: United States
facility: Arthrosi Investigative Site (114)
state: Arizona
city: El Cajon
country: United States
facility: Arthrosi Investigative Site (131)
state: California
city: Encinitas
country: United States
facility: Arthrosi Investigative Site (117)
state: California
city: Rancho Cucamonga
country: United States
facility: Arthrosi Investigative Site (138)
state: California
city: Valencia
country: United States
facility: Arthrosi Investigative Site (161)
state: California
city: Aurora
country: United States
facility: Arthrosi Investigative Site (101)
state: Colorado
city: Clearwater
country: United States
facility: Arthrosi Investigative Site (149)
state: Florida
city: Coral Gables
country: United States
facility: Arthrosi Investigative Site (115)
state: Florida
city: DeLand
country: United States
facility: Arthrosi Investigative Site (128)
state: Florida
city: Hollywood
country: United States
facility: Arthrosi Investigative Site (102)
state: Florida
city: Maitland
country: United States
facility: Arthrosi Investigative Site (156)
state: Florida
city: Miami
country: United States
facility: Arthrosi Investigative Site (103)
state: Florida
city: Palmetto Bay
country: United States
facility: Arthrosi Investigative Site (157)
state: Florida
city: Winter Haven
country: United States
facility: Arthrosi Investigative Site (151)
state: Florida
city: Atlanta
country: United States
facility: Arthrosi Investigative Site (164)
state: Georgia
city: Lilburn
country: United States
facility: Arthrosi Investigative Site (162)
state: Georgia
city: Boise
country: United States
facility: Arthrosi Investigative Site (133)
state: Idaho
city: River Forest
country: United States
facility: Arthrosi Investigative Site (122)
state: Illinois
city: Wichita
country: United States
facility: Arthrosi Investigative Site (154)
state: Kansas
city: New Orleans
country: United States
facility: Arthrosi Investigative Site (144)
state: Louisiana
city: Hagerstown
country: United States
facility: Arthrosi Investigative Site (150)
state: Maryland
city: Ann Arbor
country: United States
facility: Arthrosi Investigative Site (121)
state: Michigan
city: Detroit
country: United States
facility: Arthrosi Investigative Site (105)
state: Michigan
city: Olive Branch
country: United States
facility: Arthrosi Investigative Site (153)
state: Mississippi
city: Kansas City
country: United States
facility: Arthrosi Investigative Site (119)
state: Missouri
city: Brooklyn
country: United States
facility: Arthrosi Investigative Site (158)
state: New York
city: Greensboro
country: United States
facility: Arthrosi Investigative Site (137)
state: North Carolina
city: Shelby
country: United States
facility: Arthrosi Investigative Site (140)
state: North Carolina
city: Wilmington
country: United States
facility: Arthrosi Investigative Site (130)
state: North Carolina
city: Cleveland
country: United States
facility: Arthrosi Investigative Site (148)
state: Ohio
city: Dayton
country: United States
facility: Arthrosi Investigative Site (146)
state: Ohio
city: Hatboro
country: United States
facility: Arthrosi Investigative Site (120)
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Arthrosi Investigative Site (147)
state: South Carolina
city: Rapid City
country: United States
facility: Arthrosi Investigative Site (132)
state: South Dakota
city: Amarillo
country: United States
facility: Arthrosi Investigative Site (110)
state: Texas
city: Dallas
country: United States
facility: Arthrosi Investigative Site (104)
state: Texas
city: Graham
country: United States
facility: Arthrosi Investigative Site (116)
state: Texas
city: Lake Jackson
country: United States
facility: Arthrosi Investigative Site (126)
state: Texas
city: Missouri City
country: United States
facility: Arthrosi Investigative Site (136)
state: Texas
city: Plano
country: United States
facility: Arthrosi Investigative Site (129)
state: Texas
city: Round Rock
country: United States
facility: Arthrosi Investigative Site (127)
state: Texas
city: Tomball
country: United States
facility: Arthrosi Investigative Site (107)
state: Texas
city: Tomball
country: United States
facility: Arthrosi Investigative Site (124)
state: Texas
city: Bountiful
country: United States
facility: Arthrosi Investigative Site (142)
state: Utah
city: Ogden
country: United States
facility: Arthrosi Investigative Site (145)
state: Utah
city: Hampton
country: United States
facility: Arthrosi Investigative Site (111)
state: Virginia
city: Hampton
country: United States
facility: Arthrosi Investigative Site (118)
state: Virginia
city: Winchester
country: United States
facility: Arthrosi Investigative Site (134)
state: Virginia
city: Botany
country: Australia
facility: Arthrosi Investigative Site (202)
state: New South Wales
city: Camberwell
country: Australia
facility: Arthrosi Investigative Site (200)
state: Victoria
city: Hong Kong
country: Hong Kong
facility: Arthrosi Investigative Site (500)
state: Central
city: Hong Kong
country: Hong Kong
facility: Arthrosi Investigative Site (501)
state: Hong Kong Island
city: Auckland
country: New Zealand
facility: Arthrosi Investigative Site (302)
city: Auckland
country: New Zealand
facility: Arthrosi Investigative Site (300)
city: Hamilton
country: New Zealand
facility: Arthrosi Investigative Site (304)
city: Nelson
country: New Zealand
facility: Arthrosi Investigative Site (303)
city: Rotorua
country: New Zealand
facility: Arthrosi Investigative Site (301)
city: Hualien
country: Taiwan
facility: Arthrosi Investigative Site (405)
city: Kaohsiung City
country: Taiwan
facility: Arthrosi Investigative Site (406)
city: Kaohsiung City
country: Taiwan
facility: Arthrosi Investigative Site (404)
city: Taichung
country: Taiwan
facility: Arthrosi Investigative Site (402)
city: Taipei
country: Taiwan
facility: Arthrosi Investigative Site (400)
city: Taipei
country: Taiwan
facility: Arthrosi Investigative Site (403)
city: Taoyuan City
country: Taiwan
facility: Arthrosi Investigative Site (401)
Study officials:
affiliation: Arthrosi Therapeutics, Inc.
name: Robert Keenan, MD
role: STUDY_DIRECTOR
References: