Clinical trial NCT05119686: Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
Official title: A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Arthritis, Gouty
Hyperuricemia
Gout Chronic
Lead sponsor: Arthrosi Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 weeks.


Eligibility criteria: Inclusion Criteria:

* History of gout
* sUA \> 7 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History of kidney stones

Primary outcomes:
measure: Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
timeFrame: 6 weeks
Secondary outcomes:
measure: sUA levels < 5, < 4, and < 3 mg/dL
timeFrame: 6 weeks
measure: Incidence of Adverse Events
timeFrame: 14 weeks
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 12 weeks
measure: Time to observed Cmax (Tmax)
timeFrame: 12 weeks
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arthrosi Investigative Site
state: Arizona
city: Sun City
country: United States
facility: Arthrosi Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Arthrosi Investigative Site
state: Arizona
city: Miami Lakes
country: United States
facility: Arthrosi Investigative Site
state: Florida
city: Miami
country: United States
facility: Arthrosi Investigative Site
state: Florida
city: Tampa
country: United States
facility: Arthrosi Investigative Site
state: Florida
city: Honolulu
country: United States
facility: Arthrosi Investigative Site
state: Hawaii
city: Overland Park
country: United States
facility: Arthrosi Investigative Site
state: Kansas
city: Cleveland
country: United States
facility: Arthrosi Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Arthrosi Investigative Site
state: Ohio
city: Duncansville
country: United States
facility: Arthrosi Investigative Site
state: Pennsylvania
city: Dallas
country: United States
facility: Arthrosi Investigative Site
state: Texas
city: Houston
country: United States
facility: Arthrosi Investigative Site
state: Texas
city: Tomball
country: United States
facility: Arthrosi Investigative Site
state: Texas
city: West Jordan
country: United States
facility: Arthrosi Investigative Site
state: Utah
city: Glendale
country: United States
facility: Arthrosi Investigative Site
state: Wisconsin
city: Melbourne
country: Australia
facility: Arthrosi Investigative Site
state: Camberwell
city: Botany
country: Australia
facility: Arthrosi investigative Site
state: New South Wales
city: Taichung City
country: Taiwan
facility: Arthrosi Investigative Site
city: Taipei City
country: Taiwan
facility: Arthrosi Investigative Site - 301
city: Taipei City
country: Taiwan
facility: Arthrosi Investigative Site - 304
city: Taipei City
country: Taiwan
facility: Arthrosi Investigative Site
city: Taoyuan
country: Taiwan
facility: Arthrosi Investigative Site
Study officials:
affiliation: Arthrosi Therapeutics
name: R Keenan, MD
role: STUDY_CHAIR
References: