Clinical trial NCT05253833: Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Official title: A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous 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: 2022-02-24
Enrollment: 42
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 urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.


Eligibility criteria: Inclusion Criteria:

* History of gout
* at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
* Patients who are NOT on approved ULT must have sUA \> 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2

Exclusion Criteria:

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

Primary outcomes:
measure: Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in tophus area at Months 3 and 6
timeFrame: 12 weeks and 24 weeks
measure: Change from baseline in tophus crystal volume at Months 6
timeFrame: 24 weeks
measure: Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
timeFrame: 12 weeks
measure: Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
timeFrame: 24 weeks
measure: Incidence of Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arthrosi Investigative Site (410)
state: Alabama
city: Phoenix
country: United States
facility: Arthrosi Investigative Site (403)
state: Arizona
city: Sun City
country: United States
facility: Arthrosi Investigative Site (416)
state: Arizona
city: Tucson
country: United States
facility: Arthrosi Investigative Site (417)
state: Arizona
city: Tampa
country: United States
facility: Arthrosi Investigative Site (402)
state: Florida
city: Boise
country: United States
facility: Arthrosi Investigative Site (404)
state: Idaho
city: Ann Arbor
country: United States
facility: Arthrosi Investigative Site (409)
state: Michigan
city: Greensboro
country: United States
facility: Arthrosi Investigative Site (406)
state: North Carolina
city: Myrtle Beach
country: United States
facility: Arthrosi Investigative Site (408)
state: South Carolina
city: Dallas
country: United States
facility: Arthrosi Investigative Site (401)
state: Texas
city: Auckland
country: New Zealand
facility: Arthrosi Investigative Site (201)
city: Taichung
country: Taiwan
facility: Arthrosi Investigative Site (303)
Study officials:
affiliation: Arthrosi Therapeutics
name: R Keenan, MD
role: STUDY_CHAIR
References: