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

Phase 3

Active, not recruiting

• Conditions: Gout Chronic; Gout; Arthritis, Gouty; Hyperuricemia
• Interventions: Drug: Placebo; Drug: AR882 75 mg; Drug: AR882 50 mg

• Registration Number: NCT06439602
• Lead Sponsor: Arthrosi Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-03
• Study Start: 2024-06-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	AR882 matching placebo taken once daily for 12 months
AR882 75 mg	AR882 75 mg	AR882 75 mg taken once daily for 12 months
AR882 50 mg	AR882 50 mg	AR882 50 mg taken once daily for 12 months

Primary Outcome Measures

Name	Time	Method
Serum urate (uric acid) (sUA) level < 6 mg/dL at month 6	24 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL at month 6

Secondary Outcome Measures

Name	Time	Method
No gout flares from the end of month 9 to the end of month 12	12 weeks	Comparison of the treatment groups for the proportion of patients with no gout flares for the 3-month period from the end of month 9 to the end of month 12
Change in tophus burden by month 12	48 weeks	Comparison of the treatment groups for the proportion of patients who experience a complete response, marked or partial response, of at least 1 target tophus at Month 12, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 12 as determined using the computer-assisted photographic evaluation in rheumatology (CAPER) method
Incidence of Adverse Events	56 weeks	Treatment Emergent Adverse Events and Serious Adverse Event incidence
Serum urate (uric acid) (sUA) level < 6 mg/dL from the end of month 9 to the end of month 12	12 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 6 mg/dL for the 3-month period from the end of month 9 to the end of month 12

Trial Locations

Locations (68)

Arthrosi Investigative Site (106); 🇺🇸 Foley, Alabama, United States

Arthrosi Investigative Site (139); 🇺🇸 Anchorage, Alaska, United States

Arthrosi Investigative Site (160); 🇺🇸 Peoria, Arizona, United States

Arthrosi Investigative Site (112); 🇺🇸 Phoenix, Arizona, United States

Arthrosi Investigative Site (114); 🇺🇸 Tempe, Arizona, United States

Arthrosi Investigative Site (131); 🇺🇸 El Cajon, California, United States

Arthrosi Investigative Site (117); 🇺🇸 Encinitas, California, United States

Arthrosi Investigative Site (138); 🇺🇸 Rancho Cucamonga, California, United States

Arthrosi Investigative Site (161); 🇺🇸 Valencia, California, United States

Arthrosi Investigative Site (101); 🇺🇸 Aurora, Colorado, United States

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