AR882 + XOI for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments, AR882 (a potential new drug) and XOI (xanthine oxidase inhibitor), for people with gout who haven't found success with previous treatments like pegloticase. The researchers aim to determine if these treatments can lower uric acid levels and reduce tophus (lumps caused by gout) in those who have had issues with uricase treatments. Individuals with uncontrolled gout, visible tophus, and no uricase infusion in the past three months might be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AR882 is generally safe and well-tolerated. In earlier studies, patients taking AR882 experienced no serious side effects. Some reported mild or moderate issues such as diarrhea, headaches, and colds, which are common with many treatments.
When combined with XOI, AR882 maintained a safety record similar to earlier tests with healthy individuals, suggesting the combination is likely safe for most people.
Overall, AR882 and XOI have demonstrated promising safety results in individuals with gout, even when other treatments have failed.12345Why are researchers excited about this trial's treatments?
Most treatments for gout focus on lowering uric acid levels using medications like allopurinol or febuxostat. However, AR882 is unique because it works by inhibiting a novel target called URAT1, which plays a crucial role in the reabsorption of uric acid in the kidneys. This means AR882 can potentially reduce uric acid levels more effectively and with fewer side effects compared to traditional options. Researchers are excited about this treatment because it offers a new mechanism of action that could benefit patients who do not respond well to existing therapies. Additionally, the dosing strategy, which involves starting with a low dose and titrating up, could help minimize side effects while optimizing effectiveness.
What evidence suggests that this trial's treatments could be effective for gout?
Research has shown that using AR882 with XOI can greatly reduce uric acid levels in people with gout. One study found that AR882 alone lowered uric acid levels by 53%, outperforming other treatments like allopurinol (35%) and febuxostat (39%). In this trial, participants will receive AR882 combined with either a low or high dose of XOI, and the results are expected to be even better. Additionally, AR882 has shown promise in reducing gout lumps, with 29% of patients experiencing the complete disappearance of at least one lump. These findings suggest that AR882 and XOI together could be effective for those who haven't had success with other treatments.26789
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 people with severe gout who have not responded to uricase treatment, which includes those who had bad reactions or developed antibodies against it. Participants must have visible gout-related lumps (tophi), weigh at least 50 kg, and have adequate kidney function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AR882 75 mg plus XOI low dose for 2 weeks, then titrate to high dose for a 6-month treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Extension
Participants may opt into continuation of AR882 75 mg plus XOI high dose for an additional 6-month period
What Are the Treatments Tested in This Trial?
Interventions
- AR882
- XOI High Dose
- XOI Low Dose
Trial Overview
The study tests the combination of a high or low dose of XOI with AR882 at 75 mg to see if they can lower uric acid levels and reduce gouty lump size in patients where previous treatments failed.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
AR882 75 mg plus XOI low dose taken once daily starting on Day 1 for 2 weeks then titrate up to AR882 75 mg plus XOI high dose taken once daily for duration of 6-month treatment period in the Core Study Phase. Participants who complete the Core Study Phase can opt in to the Optional Extension Phase and continue to receive AR882 75 mg plus XOI high dose taken once daily for duration of an additional 6-month treatment period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arthrosi Therapeutics
Lead Sponsor
Citations
Evaluation of Efficacy and Safety of AR882 and XOI Co- ...
History of uncontrolled gout · Presence of ≥1 clinically visible tophus · Last uricase infusion occurred ≥3 months · Body weight no less than 50 kg · Serum ...
POS1128 COMBINATION TREATMENT OF AR882, A NEW ...
Results: In monotherapy, AR882 demonstrated better sUA lowering effect (↓53%) compared to allopurinol (↓35%) or febuxostat (↓39%). Combination of AR882 and ...
both Phase 3 trials now fully enrolled with ...
Arthrosi Therapeutics Achieves Full Enrollment of the Second Pivotal Phase 3 Trial of Pozdeutinurad (AR882) in Patients with Gout, Including ...
AR882, an Efficacious and Selective URAT1 Inhibitor for ...
At Month 6, 4 patients (29%) in the AR882 75 mg group showed complete resolution of at least one tophus, compared to 1 patient (8%) in AR882 50 ...
Arthrosi Presents Positive Phase 2 Data for AR882 at the ...
Continued treatment with AR882 demonstrated safe, efficacious and sustained reduction in sUA at 12 months —— AR882 achieved deep and ...
OP0295 A 12-WEEK, RANDOMIZED, DOUBLE-BLINDED ...
There were no serious adverse events in AR882 treated patients. Mild or moderate adverse events including diarrhea, headache, and upper respiratory infection ...
POS1128 COMBINATION TREATMENT OF AR882, A NEW ...
AR882 was well tolerated in gout patients, showing a similar safety profile to that observed in healthy volunteer studies. Conclusion: AR882 dose alone had no ...
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rheumatologyadvisor.com
rheumatologyadvisor.com/features/fda-roundup-emerging-drug-treatments-for-gout/FDA Roundup: Pipeline Drugs for Gout
AR882, when administered for 6 months, safely and effectively reduced serum uric acid levels, resolved tophus, and dissolved total crystal ...
Publications
ACR 2020 AR882, a potent and selective uricosuric agent, significantly reduced serum urate in patients with gout in a phase 2a study. Efficacy and Safety of AR ...
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