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

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06846515

Enrollment

750

Registered

2025-02-26

Start date

2025-03-11

Completion date

2026-10-01

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Gouty, Gout, Gout Chronic, Hyperuricemia

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

Interventions

DRUGAR882 50 mg

Solid Oral Capsule

DRUGAR882 75 mg

Solid Oral Capsule

DRUGPlacebo

Matching Solid Oral Capsule Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
Change in tophus burden by month 6	24 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 6, with no evidence of disease progression (no new tophus or single tophus showing progression) and patients with no new tophi formation at month 6 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

Countries

United States

Contacts

STUDY_DIRECTORRobert Keenan, MD

Arthrosi Therapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026