Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05253833
Other study ID # AR882-203
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 12, 2022
Est. completion date August 2024

Study information

Verified date February 2024
Source Arthrosi Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 42
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AR882 Dose 1
Solid Oral Capsule
AR882 Dose 2
Solid Oral Capsule
Allopurinol Tablet
Solid tablet

Locations

Country Name City State
New Zealand Arthrosi Investigative Site (201) Auckland
United States Arthrosi Investigative Site (409) Ann Arbor Michigan
United States Arthrosi Investigative Site (410) Birmingham Alabama
United States Arthrosi Investigative Site (404) Boise Idaho
United States Arthrosi Investigative Site (401) Dallas Texas
United States Arthrosi Investigative Site (406) Greensboro North Carolina
United States Arthrosi Investigative Site (408) Myrtle Beach South Carolina
United States Arthrosi Investigative Site (403) Phoenix Arizona
United States Arthrosi Investigative Site (416) Sun City Arizona
United States Arthrosi Investigative Site (402) Tampa Florida
United States Arthrosi Investigative Site (417) Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Arthrosi Therapeutics

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 12 weeks
Secondary Change from baseline in tophus area at Months 3 and 6 Comparison of the treatment groups for tophus area as measured by digital calipers 12 weeks and 24 weeks
Secondary Change from baseline in tophus crystal volume at Months 6 Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography. 24 weeks
Secondary Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3 12 weeks
Secondary Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6 24 weeks
Secondary Incidence of Adverse Events Treatment Emergent Adverse Events and Serious Adverse Event incidence. 24 weeks
See also
  Status Clinical Trial Phase
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Not yet recruiting NCT06187519 - UR+AIMS Gout Wearable Skin Uric Acid Monitor Study N/A
Completed NCT03635957 - Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout Phase 4
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT03015948 - A Single Dose Study of SHR4640 in Healthy Male Volunteers Phase 1
Completed NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study N/A
Active, not recruiting NCT02702375 - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00985127 - Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT03291782 - D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers Phase 1
Recruiting NCT03388515 - A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Enrolling by invitation NCT03336203 - The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF) Phase 4
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT04047394 - A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers Phase 1
Not yet recruiting NCT05507723 - Tight Control of Gouty Arthritis Compared to Usual Care N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2