Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

NCT ID: NCT05119686

Last Updated: 2023-05-12

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-11-17

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 weeks.

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

DOUBLE

Participants Investigators

Study Groups

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Group 1

AR882 Dose 1 x 12 weeks

Group Type EXPERIMENTAL

AR882 Dose 1

Intervention Type DRUG

Solid Oral Capsule

Group 2

AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks

Group Type EXPERIMENTAL

AR882 Dose 1

Intervention Type DRUG

Solid Oral Capsule

AR882 Dose 2

Intervention Type DRUG

Solid Oral Capsule

Group 3

AR882 matching placebo x 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Solid Oral Capsule Placebo

Interventions

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AR882 Dose 1

Solid Oral Capsule

Intervention Type DRUG

AR882 Dose 2

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
* sUA \> 7 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2

Exclusion Criteria

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* History of kidney stones
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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R Keenan, MD

Role: STUDY_CHAIR

Arthrosi Therapeutics

Locations

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Arthrosi Investigative Site

Gilbert, Arizona, United States

Site Status

Arthrosi Investigative Site

Sun City, Arizona, United States

Site Status

Arthrosi Investigative Site

Tucson, Arizona, United States

Site Status

Arthrosi Investigative Site

Miami, Florida, United States

Site Status

Arthrosi Investigative Site

Miami Lakes, Florida, United States

Site Status

Arthrosi Investigative Site

Tampa, Florida, United States

Site Status

Arthrosi Investigative Site

Honolulu, Hawaii, United States

Site Status

Arthrosi Investigative Site

Overland Park, Kansas, United States

Site Status

Arthrosi Investigative Site

Cleveland, Ohio, United States

Site Status

Arthrosi Investigative Site

Cleveland, Ohio, United States

Site Status

Arthrosi Investigative Site

Duncansville, Pennsylvania, United States

Site Status

Arthrosi Investigative Site

Dallas, Texas, United States

Site Status

Arthrosi Investigative Site

Houston, Texas, United States

Site Status

Arthrosi Investigative Site

Tomball, Texas, United States

Site Status

Arthrosi Investigative Site

West Jordan, Utah, United States

Site Status

Arthrosi Investigative Site

Glendale, Wisconsin, United States

Site Status

Arthrosi Investigative Site

Melbourne, Camberwell, Australia

Site Status

Arthrosi investigative Site

Botany, New South Wales, Australia

Site Status

Arthrosi Investigative Site

Taichung, , Taiwan

Site Status

Arthrosi Investigative Site - 301

Taipei, , Taiwan

Site Status

Arthrosi Investigative Site - 304

Taipei, , Taiwan

Site Status

Arthrosi Investigative Site

Taipei, , Taiwan

Site Status

Arthrosi Investigative Site

Taoyuan District, , Taiwan

Site Status

Countries

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United States Australia Taiwan

Other Identifiers

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AR882-202

Identifier Type: -

Identifier Source: org_study_id

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