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XO Inhibitor

AR882 + Allopurinol for Gout

Q: How many participants are admitted to this research endeavor?

The trial, sponsored by Arthrosi Therapeutics, requires a total of 36 participants to meet the inclusion criteria. The investigation will be conducted in Boise, <a href="https://www.withpower.com/clinical-trials/idaho">Idaho</a> and Greensboro <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a> with two specific sites assigned: 404 and 406 respectively.

Q: Does this trial accept geriatric participants?

This medical research is open to individuals aged 18 years and older, but not those over 75.

Q: Is this experiment currently enrolling participants?

According to the information provided on clinicaltrials.gov, this trial is currently recruiting participants from its inception date of August 12th 2022 and up until its last edit on October 14th 2022.

Q: Has the Allopurinol Tablet received regulatory endorsement from the FDA?

Evaluation of the safety profile for Allopurinol Tablet revealed a score of 2, as there is limited evidence that supports its efficacy but some data confirming its security.

Q: Are there numerous venues administering this medical research in Canada?

9 different clinical sites are currently enrolling patients in this trial. These locations include Boise, Greensboro and Tampa as well as 6 other cities. Therefore, it is strongly encouraged to select the closest site to reduce unnecessary travel requirements should one decide to participate.

Q: Is it possible for me to join this research endeavor?

This research requires volunteers aged 18-75 with <a href="https://www.withpower.com/clinical-trials/gout">gout</a> chronic. To qualify, they must show a past of this health condition, at least one tophus on the hands/wrists and/or feet/ankles that measures between 5mm and 30mm in length, an sUA level higher than 7mg/dL for those not receiving approved ULT or 6mg/dL if currently taking medically appropriate ULT treatment and have eGFR levels no lower than 45mL per min per 1.73m2. 36 participants are sought after for this study

Phase 2

Waitlist Available

Research Sponsored by Arthrosi Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are NOT on approved ULT must have sUA > 7 mg/dL

Patients who are on medically appropriate ULT must have sUA > 6 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks and 24 weeks

Awards & highlights

Study Summary

This trial will compare the effectiveness of AR882 to allopurinol in reducing gout symptoms, as well as assess safety.

Who is the study for?

This trial is for people with tophaceous gout, a type of gout where painful nodules form. Participants need high uric acid levels and at least one measurable tophus on hands/wrists or feet/ankles. They must have decent kidney function (eGFR ≥ 45 mL/min/1.73m2) and can't have had cancer (except certain skin cancers) in the last 5 years, a history of kidney stones, or be pregnant/breastfeeding.Check my eligibility

What is being tested?

The study tests AR882 alone or combined with allopurinol against allopurinol alone over 24 weeks. It aims to see how well these treatments lower uric acid levels in the blood and reduce gouty nodules while checking their safety.See study design

What are the potential side effects?

Potential side effects may include reactions related to lowering uric acid like flare-ups of joint pain, possible liver enzyme changes, rash, nausea, and other drug-specific reactions that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My uric acid level is above 6 mg/dL despite being on gout medication.

Select...

I have a gout-related swelling on my hand/wrist or foot/ankle that is between 5 and 30 mm in size.

Select...

I have had gout before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3

Secondary outcome measures

Change from baseline in tophus area at Months 3 and 6

Change from baseline in tophus crystal volume at Months 6

Incidence of Adverse Events

+2 more

Side effects data

From 2021 Phase 1 trial • 25 Patients • NCT04550234

Headache

Dizziness

Constipation

Eye pain

Nausea

Arthropod bite

Abdominal pain

Epistaxis

Swelling of eyelid

Flatulence

100%

80%

60%

40%

20%

Study treatment Arm

Treatment 1

Treatment 2

Treatment 3

Treatment 4

Treatment 5

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 3Experimental Treatment2 Interventions

AR882 Dose 1 + Allopurinol for 24 weeks

Group II: Group 2Experimental Treatment2 Interventions

AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks

Group III: Group 1Active Control1 Intervention

Allopurinol once daily for 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AR882 Dose 2

2021

Completed Phase 2

~140

Allopurinol Tablet

2021

Completed Phase 3

~130

AR882 Dose 1

2021

Completed Phase 2

~140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arthrosi TherapeuticsLead Sponsor

6 Previous Clinical Trials

316 Total Patients Enrolled

2 Trials studying Gout

170 Patients Enrolled for Gout

R Keenan, MDStudy ChairArthrosi Therapeutics

1 Previous Clinical Trials

140 Total Patients Enrolled

1 Trials studying Gout

140 Patients Enrolled for Gout

Media Library

Allopurinol Tablet (XO Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05253833 — Phase 2

Gout Research Study Groups: Group 3, Group 1, Group 2

Gout Clinical Trial 2023: Allopurinol Tablet Highlights & Side Effects. Trial Name: NCT05253833 — Phase 2

Allopurinol Tablet (XO Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05253833 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are admitted to this research endeavor?

"The trial, sponsored by Arthrosi Therapeutics, requires a total of 36 participants to meet the inclusion criteria. The investigation will be conducted in Boise, Idaho and Greensboro North carolina with two specific sites assigned: 404 and 406 respectively."

Answered by AI

Does this trial accept geriatric participants?

"This medical research is open to individuals aged 18 years and older, but not those over 75."

Answered by AI

Is this experiment currently enrolling participants?

"According to the information provided on clinicaltrials.gov, this trial is currently recruiting participants from its inception date of August 12th 2022 and up until its last edit on October 14th 2022."

Answered by AI

Has the Allopurinol Tablet received regulatory endorsement from the FDA?

"Evaluation of the safety profile for Allopurinol Tablet revealed a score of 2, as there is limited evidence that supports its efficacy but some data confirming its security."

Answered by AI

Are there numerous venues administering this medical research in Canada?

"9 different clinical sites are currently enrolling patients in this trial. These locations include Boise, Greensboro and Tampa as well as 6 other cities. Therefore, it is strongly encouraged to select the closest site to reduce unnecessary travel requirements should one decide to participate."

Answered by AI

Is it possible for me to join this research endeavor?

"This research requires volunteers aged 18-75 with gout chronic. To qualify, they must show a past of this health condition, at least one tophus on the hands/wrists and/or feet/ankles that measures between 5mm and 30mm in length, an sUA level higher than 7mg/dL for those not receiving approved ULT or 6mg/dL if currently taking medically appropriate ULT treatment and have eGFR levels no lower than 45mL per min per 1.73m2. 36 participants are sought after for this study"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

2022. "Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05253833.

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