AR882 for Gout

Not currently recruiting at 93 trial locations

Overseen By Director Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Arthrosi Therapeutics

Disqualifiers: Malignancy, Pregnant, Kidney stones, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of a new treatment, AR882, a potential uric acid-lowering drug, for people with gout. Gout causes painful flare-ups due to high uric acid levels in the blood. Participants will take AR882 once daily for a year at one of two doses, or they may receive a placebo (a pill with no active medicine). This trial suits those who have had gout for some time, have experienced at least two flare-ups in the past year, and are not currently on certain uric acid-lowering medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that patients on approved urate-lowering therapy (ULT) can participate if their serum uric acid levels are above a certain threshold, suggesting you might be able to continue those medications.

Is there any evidence suggesting that AR882 is likely to be safe for humans?

Previous studies found that AR882 was well-tolerated when used alone or with the gout medication allopurinol. Most participants did not experience serious side effects. The most common issue was a gout flare-up, occurring in about 30% of patients. A flare-up involves increased joint pain and swelling that can occur when starting gout treatment. No serious adverse events were reported in those who took AR882. These findings suggest that AR882 is generally safe for people with gout. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gout?

Researchers are excited about AR882 for gout because it offers a novel approach to managing this painful condition. Unlike traditional treatments like allopurinol and febuxostat, which primarily focus on reducing uric acid production, AR882 is a potent urate transporter 1 (URAT1) inhibitor. This means it works by increasing the excretion of uric acid through the kidneys, potentially offering a more effective way to lower uric acid levels in the blood. Additionally, AR882 comes in convenient daily doses, which could improve adherence and outcomes for patients.

What evidence suggests that AR882 might be an effective treatment for gout?

Studies have shown that AR882 can significantly lower uric acid levels in patients with gout. Specifically, a 75 mg dose of AR882, one of the doses tested in this trial, effectively reduces urate crystals, which often indicate gout severity. This treatment has also produced impressive results in patients with tophaceous gout, a severe form with large crystal deposits. Research suggests that AR882 may work better and be as safe as current gout treatments. Overall, these findings indicate that AR882 could be a promising option for managing gout symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert Keenan, MD

Principal Investigator

Arthrosi Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for gout patients who need treatment to lower their uric acid levels. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

My weight is at least 50 kg.

I have had gout before.

My uric acid level is 7 mg/dL or higher and I am not on urate-lowering therapy.

Exclusion Criteria

Pregnant or breastfeeding

I have had painful kidney stones in the last 6 months.

I haven't had cancer in the last 5 years, except for skin cancer that was treated successfully.

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

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 trial is testing the effectiveness of a new medication called AR882 in two different doses (50 mg and 75 mg) against a placebo over a period of one year to see if it can reduce uric acid levels in people with gout.

How Is the Trial Designed?

Group I: AR882 75 mg Experimental Treatment 1 Intervention

AR882 75 mg taken once daily for 12 months

Group II: AR882 50 mg Experimental Treatment 1 Intervention

AR882 50 mg taken once daily for 12 months

Group III: Placebo Placebo Group 1 Intervention

AR882 matching placebo taken once daily for 12 months

Who Is Running the Clinical Trial?

Arthrosi Therapeutics

Lead Sponsor

Trials

9

Recruited

1,900+

Published Research Related to This Trial

In a mouse model of acute gout, the presence of CXCR-2 ligands was found to be crucial for the development of neutrophil-driven inflammation in response to urate crystals, with a significant increase in neutrophils observed in normal mice.

Mice lacking the CXCR-2 receptor showed a markedly reduced inflammatory response, indicating that CXCR-2 is essential for neutrophil recruitment and activation during acute gout inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The murine homolog of the interleukin-8 receptor CXCR-2 is essential for the occurrence of neutrophilic inflammation in the air pouch model of acute urate crystal-induced gouty synovitis. Terkeltaub, R., Baird, S., Sears, P., et al.[2007]

A systematic review of 20 articles found that various interventions, particularly nurse-led programs, significantly improved patient adherence to urate-lowering therapy (ULT) and reduced serum urate (SU) levels in gout patients.

Nurse-led interventions were especially effective as they empowered patients through education and ongoing support, while pharmacist-led and multidisciplinary approaches also contributed to better medication adherence and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve uptake of urate-lowering therapy in patients with gout: a systematic review. Gill, I., Dalbeth, N., 'Ofanoa, M., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A 12-week treatment combining allopurinol and movalis significantly reduced the frequency of gout flare-ups and improved patients' quality of life, with over two-thirds of patients experiencing no worsening of joint symptoms.

The therapy was well-tolerated, showing no significant adverse effects or changes in blood pressure or kidney function, and 90.9% of patients rated their treatment outcome as very good.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a 12-week allopurinol-lowering therapy in combination with the non-steroidal anti-inflammatory drug meloxicam in patients with gout]. Gromova, MA., Tsurko, VV., Kislyak, OA., et al.[2022]

In a phase II trial with 32 gout volunteers, the combination of arhalofenate (ARH) and febuxostat (FBX) significantly reduced serum uric acid (SUA) levels, achieving a 63% decrease with ARH 800 mg and FBX 80 mg, with all subjects reaching SUA levels below 6 mg/dl.

The combination therapy was well tolerated and safe, demonstrating complementary mechanisms of action that enhanced uric acid lowering compared to either drug alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout. Steinberg, AS., Vince, BD., Choi, YJ., et al.[2018]

The study found that Toll-like receptors TLR-2 and TLR-4, along with the MyD88 protein, are essential for macrophages to effectively recognize and respond to monosodium urate (MSU) crystals, which are involved in gout inflammation.

In experiments with mice lacking these receptors, there was significantly reduced uptake of MSU crystals and lower production of key inflammatory cytokines, indicating that these receptors play a crucial role in the inflammatory response associated with gouty arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innate immunity conferred by Toll-like receptors 2 and 4 and myeloid differentiation factor 88 expression is pivotal to monosodium urate monohydrate crystal-induced inflammation. Liu-Bryan, R., Scott, P., Sydlaske, A., et al.[2022]

In a phase III study involving 1315 adults with gout, weekly subcutaneous rilonacept 160 mg significantly reduced the frequency of gout flares by 70.3% compared to placebo, demonstrating its efficacy in preventing gout attacks.

The safety profile of rilonacept was consistent with previous studies, with no new safety concerns identified; however, there were more injection site reactions and slightly higher withdrawal rates due to adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study. Sundy, JS., Schumacher, HR., Kivitz, A., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 60 patients with acute gouty arthritis, the combination of electroacupuncture, blood-letting puncture, and cupping showed a significantly higher effective rate of 96.7% compared to 86.7% for the control group receiving Probenecid.

Both treatments reduced blood uric acid levels, but the observation group had significantly lower levels post-treatment, indicating that the combined therapy may be more effective in managing gout symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Observation on therapeutic effect of electroacupuncture plus blood-letting puncture and cupping combined with diet intervention for treatment of acute gouty arthritis]. Zhao, QW., Liu, J., Qu, XD., et al.[2013]

Citations

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arthrosi.com/arthrosi-therapeutics-achieves-full-enrollment-of-the-second-pivotal-phase-3-trial-of-pozdeutinurad-ar882-in-patients-with-gout-including-those-with-tophaceous-gout/

both Phase 3 trials now fully enrolled with ...

Pozdeutinurad has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05119686

Phase 2b Evaluation of Efficacy and Safety of AR882 in ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

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ard.bmj.com

ard.bmj.com/content/83/Suppl_1/409.2

POS0268 AR882, A NOVEL AND SELECTIVE URAT1 ...

The AR882 75 mg alone or combined with allopurinol showed reduction of total urate crystal volume from baseline to Month 6 with sustained crystal volume ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003496724637180

OP0295 A 12-WEEK, RANDOMIZED, DOUBLE-BLINDED ...

This study suggests AR882 may offer improved efficacy with acceptable safety compared to existing therapies for gout and may have utility in the treatment of ...

5.

prnewswire.com

prnewswire.com/news-releases/arthrosi-presents-positive-long-term-safety-and-efficacy-data-for-pozdeutinurad-ar882-at-the-european-alliance-of-associations-for-rheumatology-eular-congress-2025-302479045.html

Arthrosi Presents Positive Long-Term Safety and Efficacy ...

Data demonstrates that pozdeutinurad alone or in combination achieves significant reduction in sUA levels in patients with tophaceous gout ...

6.

acrabstracts.org

acrabstracts.org/abstract/efficacy-and-safety-of-ar882-a-selective-uric-acid-transporter-1-urat1-inhibitor-in-gout-patients-with-various-baseline-characteristics-following-12-week-treatment-in-patients/

Efficacy and Safety of AR882, a Selective Uric Acid ...

There were no serious adverse events in AR882 treated patients. The most frequently reported adverse event was gout flare occurring in 30% of patients overall ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003496725013354

OP0300 SAFETY AND TOLERABILITY OF ...

Pozdeutinurad (AR882), a novel and selective URAT1 inhibitor, has demonstrated significant sustained reduction in serum urate (sUA), marked reduction in ...