750 Participants Needed

AR882 for Gout

Recruiting at 80 trial locations
DC
Overseen ByDirector Clinical Operations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Arthrosi Therapeutics
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients on urate-lowering therapy (ULT) can participate, so you may be able to continue those medications.

What safety data exists for AR882 (Arhalofenate) in humans?

Arhalofenate, also known as AR882, has been studied for safety in people with gout. It was generally well-tolerated when used with another gout medication, febuxostat, and showed a reduction in arthritis flares.12345

How is the drug AR882 different from other gout treatments?

AR882, also known as arhalofenate, is unique because it not only helps lower uric acid levels in the blood but also reduces the frequency of gout flares by inhibiting inflammation through a specific pathway (AMPK signaling). This dual action sets it apart from other treatments that typically focus on just lowering uric acid.23467

What data supports the effectiveness of the drug AR882 for treating gout?

Research on arhalofenate, a component of AR882, shows it can lower uric acid levels and reduce gout flares by inhibiting certain inflammatory responses. This suggests AR882 might be effective for gout by similar mechanisms.348910

Who Is on the Research Team?

RK

Robert Keenan, MD

Principal Investigator

Arthrosi Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with gout, characterized by high uric acid levels. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific range of uric acid levels.

Inclusion Criteria

My kidney function is within the required range.
My uric acid level is above 6 mg/dL despite being on treatment.
My uric acid level is 7 mg/dL or higher and I am not on urate-lowering therapy.
See 3 more

Exclusion Criteria

I haven't had cancer in the last 5 years, except for skin cancer that was treated successfully.
Pregnant or breastfeeding
I have had painful kidney stones in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AR882 or placebo once daily for 12 months to assess serum uric acid lowering effect and safety

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AR882
Trial Overview The study is testing the effectiveness and safety of AR882 in reducing serum uric acid in gout patients. Two different doses of AR882 (50 mg and 75 mg) will be compared against a placebo over the course of 12 months.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: AR882 75 mgExperimental Treatment1 Intervention
Group II: AR882 50 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arthrosi Therapeutics

Lead Sponsor

Trials
9
Recruited
1,900+

Published Research Related to This Trial

A systematic review of 68 gout trials revealed that the average number of recommended OMERACT outcome domains reported was low, with only 2.9 for acute and 2.5 for chronic gout trials, indicating a lack of adherence to established guidelines.
Key aspects such as health-related quality of life and joint damage imaging were not assessed in any of the trials, highlighting significant gaps in the evaluation of gout interventions.
Outcomes assessed in trials of gout and accordance with OMERACT-proposed domains: a systematic literature review.Araújo, F., Cordeiro, I., Ramiro, S., et al.[2018]
Arhalofenate acid significantly reduces inflammation and acute arthritis flares in gout by inhibiting the NLRP3 inflammasome and activating AMPK, as shown in both murine models and macrophage studies.
In vivo studies demonstrated that arhalofenate treatment decreased leukocyte and neutrophil influx, as well as inflammatory cytokines, indicating its potential as an effective anti-inflammatory treatment for gout.
Arhalofenate acid inhibits monosodium urate crystal-induced inflammatory responses through activation of AMP-activated protein kinase (AMPK) signaling.McWherter, C., Choi, YJ., Serrano, RL., et al.[2019]
A study is being conducted to evaluate the effectiveness of a personalized smartphone app for self-managing gout, aiming to improve adherence to urate-lowering therapy (ULT) and achieve target serum urate levels of 0.36 mmol/L or less in patients.
The trial involves a cluster randomized design with GP practices, and it aims to show at least a 30% improvement in achieving target serum urate levels in the intervention group compared to a control group over 6 months, with a total of 6 and 12-month follow-up for various health outcomes.
Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol.Day, RO., Frensham, LJ., Nguyen, AD., et al.[2019]

Citations

Outcomes assessed in trials of gout and accordance with OMERACT-proposed domains: a systematic literature review. [2018]
Arhalofenate acid inhibits monosodium urate crystal-induced inflammatory responses through activation of AMP-activated protein kinase (AMPK) signaling. [2019]
Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol. [2019]
The Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout. [2018]
[Observation on therapeutic effect of electroacupuncture plus blood-letting puncture and cupping combined with diet intervention for treatment of acute gouty arthritis]. [2013]
Novel natural scaffold as hURAT1 inhibitor identified by 3D-shape-based, docking-based virtual screening approach and biological evaluation. [2022]
Angiotensin type 2 receptor antagonism as a new target to manage gout. [2023]
Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase III Placebo-Controlled Study. [2020]
The epidemiology and treatment of gout. [2020]
Attenuation of monosodium urate crystal-induced arthritis in rabbits by a neutralizing antibody against interleukin-8. [2019]
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