Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)

NCT06439602 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: AR882-302
• Study Type: interventional
• Target: 750
• Locations: 5 countries
• Sites: 68

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

Conditions

Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic

Outcome Measures

Primary Outcomes (1)

• Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6

  Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6

  24 weeks

Secondary Outcomes (4)

• Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12

  12 weeks

• No gout flares from the end of month 9 to the end of month 12

  12 weeks

• Change in tophus burden by month 12

  48 weeks

• Incidence of Adverse Events

  56 weeks

Study Arms (3)

AR882 50 mg

EXPERIMENTAL

AR882 50 mg taken once daily for 12 months

Drug: AR882 50 mg

AR882 75 mg

EXPERIMENTAL

AR882 75 mg taken once daily for 12 months

Drug: AR882 75 mg

Placebo

PLACEBO COMPARATOR

AR882 matching placebo taken once daily for 12 months

Drug: Placebo

Interventions

AR882 50 mg DRUG

Solid Oral Capsule

AR882 50 mg

AR882 75 mg DRUG

Solid Oral Capsule

AR882 75 mg

Placebo DRUG

Matching Solid Oral Capsule Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthrosi Therapeutics: lead

Study Sites (68)

Arthrosi Investigative Site (106)

Foley, Alabama, 36535, United States

Location

Arthrosi Investigative Site (139)

Anchorage, Alaska, 99508, United States

Location

Arthrosi Investigative Site (160)

Peoria, Arizona, 85381, United States

Location

Arthrosi Investigative Site (112)

Phoenix, Arizona, 85037, United States

Location

Arthrosi Investigative Site (114)

Tempe, Arizona, 85281, United States

Location

Arthrosi Investigative Site (131)

El Cajon, California, 92108, United States

Location

Arthrosi Investigative Site (117)

Encinitas, California, 92024, United States

Location

Arthrosi Investigative Site (138)

Rancho Cucamonga, California, 91730, United States

Location

Arthrosi Investigative Site (161)

Valencia, California, 28277, United States

Location

Arthrosi Investigative Site (101)

Aurora, Colorado, 80014, United States

Location

Arthrosi Investigative Site (149)

Clearwater, Florida, 33756, United States

Location

Arthrosi Investigative Site (115)

Coral Gables, Florida, 33134, United States

Location

Arthrosi Investigative Site (128)

DeLand, Florida, 32720, United States

Location

Arthrosi Investigative Site (102)

Hollywood, Florida, 33024, United States

Location

Arthrosi Investigative Site (156)

Maitland, Florida, 32751, United States

Location

Arthrosi Investigative Site (103)

Miami, Florida, 33176, United States

Location

Arthrosi Investigative Site (157)

Palmetto Bay, Florida, 91355, United States

Location

Arthrosi Investigative Site (151)

Winter Haven, Florida, 33880, United States

Location

Arthrosi Investigative Site (164)

Atlanta, Georgia, 30329, United States

Location

Arthrosi Investigative Site (162)

Lilburn, Georgia, 30047, United States

Location

Arthrosi Investigative Site (133)

Boise, Idaho, 83713, United States

Location

Arthrosi Investigative Site (122)

River Forest, Illinois, 48109, United States

Location

Arthrosi Investigative Site (154)

Wichita, Kansas, 67207, United States

Location

Arthrosi Investigative Site (144)

New Orleans, Louisiana, 70115, United States

Location

Arthrosi Investigative Site (150)

Hagerstown, Maryland, 21740, United States

Location

Arthrosi Investigative Site (121)

Ann Arbor, Michigan, 48109, United States

Location

Arthrosi Investigative Site (105)

Detroit, Michigan, 48076, United States

Location

Arthrosi Investigative Site (153)

Olive Branch, Mississippi, 38654-3514, United States

Location

Arthrosi Investigative Site (119)

Kansas City, Missouri, 64151, United States

Location

Arthrosi Investigative Site (158)

Brooklyn, New York, 11215, United States

Location

Arthrosi Investigative Site (137)

Greensboro, North Carolina, 27410, United States

Location

Arthrosi Investigative Site (140)

Shelby, North Carolina, 28150, United States

Location

Arthrosi Investigative Site (130)

Wilmington, North Carolina, 28403, United States

Location

Arthrosi Investigative Site (148)

Cleveland, Ohio, 44195, United States

Location

Arthrosi Investigative Site (146)

Dayton, Ohio, 45429, United States

Location

Arthrosi Investigative Site (120)

Hatboro, Pennsylvania, 19040, United States

Location

Arthrosi Investigative Site (147)

Myrtle Beach, South Carolina, 29572, United States

Location

Arthrosi Investigative Site (132)

Rapid City, South Dakota, 57702, United States

Location

Arthrosi Investigative Site (110)

Amarillo, Texas, 79106, United States

Location

Arthrosi Investigative Site (104)

Dallas, Texas, 75251, United States

Location

Arthrosi Investigative Site (116)

Graham, Texas, 76450, United States

Location

Arthrosi Investigative Site (126)

Lake Jackson, Texas, 77566, United States

Location

Arthrosi Investigative Site (136)

Missouri City, Texas, 77459, United States

Location

Arthrosi Investigative Site (129)

Plano, Texas, 75024, United States

Location

Arthrosi Investigative Site (127)

Round Rock, Texas, 78681, United States

Location

Arthrosi Investigative Site (107)

Tomball, Texas, 77375, United States

Location

Arthrosi Investigative Site (124)

Tomball, Texas, 77377, United States

Location

Arthrosi Investigative Site (142)

Bountiful, Utah, 98021, United States

Location

Arthrosi Investigative Site (145)

Ogden, Utah, 84405, United States

Location

Arthrosi Investigative Site (111)

Hampton, Virginia, 23666, United States

Location

Arthrosi Investigative Site (118)

Hampton, Virginia, 23666, United States

Location

Arthrosi Investigative Site (134)

Winchester, Virginia, 22601, United States

Location

Arthrosi Investigative Site (202)

Botany, New South Wales, 2019, Australia

Location

Arthrosi Investigative Site (200)

Camberwell, Victoria, 3124, Australia

Location

Arthrosi Investigative Site (500)

Hong Kong, Central, Hong Kong

Location

Arthrosi Investigative Site (501)

Hong Kong, Hong Kong Island, Hong Kong

Location

Arthrosi Investigative Site (300)

Auckland, Auckland, 1010, New Zealand

Location

Arthrosi Investigative Site (304)

Hamilton, Hamilton, 3200, New Zealand

Location

Arthrosi Investigative Site (302)

Auckland, New Zealand, 0632, New Zealand

Location

Arthrosi Investigative Site (303)

Nelson, New Zealand, 7011, New Zealand

Location

Arthrosi Investigative Site (301)

Rotorua, New Zealand, 3010, New Zealand

Location

Arthrosi Investigative Site (405)

Hualien City, Taiwan, 97002, Taiwan

Location

Arthrosi Investigative Site (404)

Kaohsiung City, Taiwan, 833, Taiwan

Location

Arthrosi Investigative Site (400)

Taipei, Taiwan, 11217, Taiwan

Location

Arthrosi Investigative Site (403)

Taipei, Taiwan, 112, Taiwan

Location

Arthrosi Investigative Site (401)

Taoyuan, Taiwan, 333, Taiwan

Location

Arthrosi Investigative Site (406)

Kaohsiung City, 813, Taiwan

Location

Arthrosi Investigative Site (402)

Taichung, 402, Taiwan

Location

MeSH Terms

Conditions

Gout; Arthritis, Gouty; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Keenan, MD

  Arthrosi Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); US (52); NZ (5); TW (7); AU (2)