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XO Inhibitor

AR882 + Allopurinol for Gout

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
Must not have
History of kidney stones
Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks and 24 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had kidney stones in the past.
Select...
I haven't had cancer in the last 5 years, except for skin cancer that was treated successfully.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Secondary study objectives
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
8%
Headache
4%
Swelling of eyelid
4%
Epistaxis
4%
Eye pain
4%
Abdominal pain
4%
Constipation
4%
Nausea
4%
Dizziness
4%
Flatulence
4%
Arthropod bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment 1
Treatment 2
Treatment 3
Treatment 4
Treatment 5

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 1
2022
Completed Phase 2
~190
AR882 Dose 2
2022
Completed Phase 2
~190
Allopurinol Tablet
2022
Completed Phase 3
~170

Find a Location

Who is running the clinical trial?

Arthrosi TherapeuticsLead Sponsor
7 Previous Clinical Trials
1,066 Total Patients Enrolled
3 Trials studying Gout
920 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
~13 spots leftby Dec 2025
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