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

NCT ID: NCT06439602

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-26

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Gout Arthritis, Gouty Hyperuricemia Gout Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AR882 50 mg

AR882 50 mg taken once daily for 12 months

Group Type EXPERIMENTAL

AR882 50 mg

Intervention Type DRUG

Solid Oral Capsule

AR882 75 mg

AR882 75 mg taken once daily for 12 months

Group Type EXPERIMENTAL

AR882 75 mg

Intervention Type DRUG

Solid Oral Capsule

Placebo

AR882 matching placebo taken once daily for 12 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Solid Oral Capsule Placebo

Interventions

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AR882 50 mg

Solid Oral Capsule

Intervention Type DRUG

AR882 75 mg

Solid Oral Capsule

Intervention Type DRUG

Placebo

Matching Solid Oral Capsule Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrosi Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Keenan, MD

Role: STUDY_DIRECTOR

Arthrosi Therapeutics, Inc.

Locations

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Arthrosi Investigative Site (106)

Foley, Alabama, United States

Site Status

Arthrosi Investigative Site (139)

Anchorage, Alaska, United States

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Arthrosi Investigative Site (160)

Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Arthrosi Investigative Site (114)

Tempe, Arizona, United States

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Arthrosi Investigative Site (131)

El Cajon, California, United States

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Encinitas, California, United States

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Rancho Cucamonga, California, United States

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Valencia, California, United States

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Aurora, Colorado, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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DeLand, Florida, United States

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Hollywood, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Palmetto Bay, Florida, United States

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Winter Haven, Florida, United States

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Atlanta, Georgia, United States

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Lilburn, Georgia, United States

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Boise, Idaho, United States

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River Forest, Illinois, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Hagerstown, Maryland, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Olive Branch, Mississippi, United States

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Kansas City, Missouri, United States

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Brooklyn, New York, United States

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Greensboro, North Carolina, United States

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Shelby, North Carolina, United States

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Wilmington, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Hatboro, Pennsylvania, United States

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Myrtle Beach, South Carolina, United States

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Rapid City, South Dakota, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Graham, Texas, United States

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Lake Jackson, Texas, United States

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Missouri City, Texas, United States

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Plano, Texas, United States

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Round Rock, Texas, United States

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Tomball, Texas, United States

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Tomball, Texas, United States

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Bountiful, Utah, United States

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Ogden, Utah, United States

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Hampton, Virginia, United States

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Hampton, Virginia, United States

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Winchester, Virginia, United States

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Botany, New South Wales, Australia

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Camberwell, Victoria, Australia

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Hong Kong, Central, Hong Kong

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Hong Kong, Hong Kong Island, Hong Kong

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Auckland, Auckland, New Zealand

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Hamilton, Hamilton, New Zealand

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Auckland, New Zealand, New Zealand

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Nelson, New Zealand, New Zealand

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Rotorua, New Zealand, New Zealand

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Arthrosi Investigative Site (405)

Hualien City, Taiwan, Taiwan

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Arthrosi Investigative Site (404)

Kaohsiung City, Taiwan, Taiwan

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Arthrosi Investigative Site (400)

Taipei, Taiwan, Taiwan

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Arthrosi Investigative Site (403)

Taipei, Taiwan, Taiwan

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Arthrosi Investigative Site (401)

Taoyuan, Taiwan, Taiwan

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Arthrosi Investigative Site (406)

Kaohsiung City, , Taiwan

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Arthrosi Investigative Site (402)

Taichung, , Taiwan

Site Status

Countries

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United States Australia Hong Kong New Zealand Taiwan

Other Identifiers

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AR882-302

Identifier Type: -

Identifier Source: org_study_id

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