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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06846515
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Arthrosi Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Keenan, MD
Principal Investigator Affiliation	Arthrosi Therapeutics, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

Arms & Interventions

Arms

Experimental: AR882 50 mg

AR882 50 mg taken once daily for 12 months

Experimental: AR882 75 mg

AR882 75 mg taken once daily for 12 months

Placebo Comparator: Placebo

AR882 matching placebo taken once daily for 12 months

Interventions

Drug: - AR882 50 mg

Solid Oral Capsule

Drug: - AR882 75 mg

Solid Oral Capsule

Drug: - Placebo

Matching Solid Oral Capsule Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arthrosi Investigative Site (620), Birmingham, Alabama

Status

Not yet recruiting

Address

Arthrosi Investigative Site (620)

Birmingham, Alabama, 35215

Site Contact

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