Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

NCT06846515 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: AR882-301
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 89

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)

• Change in tophus burden by month 12

  48 weeks

• 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

• 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 (89)

Arthrosi Investigative Site (620)

Birmingham, Alabama, 35215, United States

Location

Arthrosi Investigative Site (616)

Huntsville, Alabama, 35801, United States

Location

Arthrosi Investigative Site (680)

Peoria, Arizona, 85381, United States

Location

Arthrosi Investigative Site (640)

Phoenix, Arizona, 85018, United States

Location

Arthrosi Investigative Site (617)

Little Rock, Arkansas, 72205, United States

Location

Arthrosi Investigative Site (614)

Garden Grove, California, 92844, United States

Location

Arthrosi Investigative Site (618)

La Mesa, California, 91942, United States

Location

Arthrosi Investigative Site (687)

La Mesa, California, 91942, United States

Location

Arthrosi Investigative Site (655)

La Palma, California, 90623, United States

Location

Arthrosi Investigative Site (632)

Lincoln, California, 95648, United States

Location

Arthrosi Investigative Site (605)

Lomita, California, 90717, United States

Location

Arthrosi Investigative Site (675)

Long Beach, California, 90806, United States

Location

Arthrosi Investigative Site (603)

Santa Monica, California, 90404, United States

Location

Arthrosi Investigative Site (672)

Tarzana, California, 91356, United States

Location

Arthrosi Investigative Site (656)

Thousand Oaks, California, 91360, United States

Location

Arthrosi Investigative Site (660)

Aurora, Colorado, 80012, United States

Location

Arthrosi Investigative Site (669)

Colorado Springs, Colorado, 80909, United States

Location

Arthrosi Investigative Site (612)

Fort Collins, Colorado, 80528, United States

Location

Arthrosi Investigative Site (665)

Cooper City, Florida, 33024, United States

Location

Arthrosi Investigative Site (613)

Jupiter, Florida, 33458, United States

Location

Arthrosi Investigative Site (611)

Miami, Florida, 33173, United States

Location

Arthrosi Investigative Site (644)

Miami, Florida, 33176, United States

Location

Arthrosi Investigative Site (694)

Palmetto Bay, Florida, 33157, United States

Location

Arthrosi Investigative Site (615)

Sanford, Florida, 32771, United States

Location

Arthrosi Investigative Site (600)

Tampa, Florida, 33609, United States

Location

Arthrosi Investigative Site (673)

Atlanta, Georgia, 30329, United States

Location

Arthrosi Investigative Site (682)

Lilburn, Georgia, 30047, United States

Location

Arthrosi Investigative Site (652)

Marietta, Georgia, 30060, United States

Location

Arthrosi Investigative Site (658)

Honolulu, Hawaii, 96814, United States

Location

Arthrosi Investigative Site (676)

Boise, Idaho, 83713, United States

Location

Arthrosi Investigative Site (634)

Meridian, Idaho, 83642, United States

Location

Arthrosi Investigative Site (657)

Chicago, Illinois, 60602, United States

Location

Arthrosi Investigative Site (648)

Melrose Park, Illinois, 60160, United States

Location

Arthrosi Investigative Site (678)

Indianapolis, Indiana, 46202, United States

Location

Arthrosi Investigative Site (679)

Overland Park, Kansas, 66209, United States

Location

Arthrosi Investigative Site (674)

Louisville, Kentucky, 40205, United States

Location

Arthrosi Investigative Site (627)

Mandeville, Louisiana, 70471, United States

Location

Arthrosi Investigative Site (650)

New Orleans, Louisiana, 70115, United States

Location

Arthrosi Investigative Site (641)

Prairieville, Louisiana, 70769, United States

Location

Arthrosi Investigative Site (662)

Oxon Hill, Maryland, 20745, United States

Location

Arthrosi Investigative Site (653)

Rockville, Maryland, 20852, United States

Location

Arthrosi Investigative Site (636)

Fall River, Massachusetts, 02721, United States

Location

Arthrosi Investigative Site (622)

Bay City, Michigan, 48706, United States

Location

Arthrosi Investigative Site (628)

Farmington Hills, Michigan, 48334, United States

Location

Arthrosi Investigative Site (645)

Southfield, Michigan, 48076, United States

Location

Arthrosi Investigative Site (633)

Gulfport, Mississippi, 39503, United States

Location

Arthrosi Investigative Site (635)

Jackson, Mississippi, 39202, United States

Location

Arthrosi Investigative Site (693)

Olive Branch, Mississippi, 38654, United States

Location

Arthrosi Investigative Site (637)

Springfield, Missouri, 65807, United States

Location

Arthrosi Investigative Site (626)

Town and Country, Missouri, 63017, United States

Location

Arthrosi Investigative Site (664)

Missoula, Montana, 59808, United States

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Arthrosi Investigative Site (610)

Lincoln, Nebraska, 68516, United States

Location

Arthrosi Investigative Site (684)

Omaha, Nebraska, 68114, United States

Location

Arthrosi Investigative Site (651)

Omaha, Nebraska, 68144, United States

Location

Arthrosi Investigative Site (686)

Las Vegas, Nevada, 89102, United States

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Arthrosi Investigative Site (661)

Brooklyn, New York, 11215, United States

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Arthrosi Investigative Site (663)

Hartsdale, New York, 10530, United States

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Arthrosi Investigative Site (625)

Charlotte, North Carolina, 28207, United States

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Arthrosi Investigative Site (681)

Charlotte, North Carolina, 28277, United States

Location

Arthrosi Investigative Site (683)

Raleigh, North Carolina, 27607, United States

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Arthrosi Investigative Site (649)

Shelby, North Carolina, 28150, United States

Location

Arthrosi Investigative Site (666)

Fargo, North Dakota, 58104, United States

Location

Arthrosi Investigative Site (671)

Mason, Ohio, 45040, United States

Location

Arthrosi Investigative Site (631)

Norman, Oklahoma, 73072, United States

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Arthrosi Investigative Site (642)

Tulsa, Oklahoma, 74133, United States

Location

Arthrosi Investigative Site (647)

Horsham, Pennsylvania, 19044, United States

Location

Arthrosi Investigative Site (623)

Philadelphia, Pennsylvania, 19107, United States

Location

Arthrosi Investigative Site (638)

Charleston, South Carolina, 29407, United States

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Arthrosi Investigative Site (604)

Fort Mill, South Carolina, 29707, United States

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Arthrosi Investigative Site (608)

North Charleston, South Carolina, 29405, United States

Location

Arthrosi Investigative Site (619)

Chattanooga, Tennessee, 37404, United States

Location

Arthrosi Investigative Site (624)

Hendersonville, Tennessee, 37075, United States

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Arthrosi Investigative Site (670)

Amarillo, Texas, 79106, United States

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Arthrosi Investigative Site (677)

Austin, Texas, 78735, United States

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Arthrosi Investigative Site (690)

Dallas, Texas, 75251, United States

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Arthrosi Investigative Site (639)

DeSoto, Texas, 75115, United States

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Arthrosi Investigative Site (601)

Houston, Texas, 77074, United States

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Arthrosi Investigative Site (688)

Plano, Texas, 75024, United States

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Arthrosi Investigative Site (689)

Prosper, Texas, 75078, United States

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Arthrosi Investigative Site (607)

Sugar Land, Texas, 77479, United States

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Arthrosi Investigative Site (646)

Tomball, Texas, 77375, United States

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Arthrosi Investigative Site (659)

Tomball, Texas, 77375, United States

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Arthrosi Investigative Site (643)

Clinton, Utah, 84015, United States

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Arthrosi Investigative Site (609)

Salt Lake City, Utah, 84121, United States

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Arthrosi Investigative Site (654)

Salt Lake City, Utah, 84124, United States

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Arthrosi Investigative Site (606)

Charlottesville, Virginia, 29911, United States

Location

Arthrosi Investigative Site (691)

Winchester, Virginia, 22601, United States

Location

Arthrosi Investigative Site (685)

Bellevue, Washington, 98004, United States

Location

Arthrosi Investigative Site (668)

Kenosha, Wisconsin, 53144, United States

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: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 11, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (89)