GoutPhase 2NCT05253833
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
A Phase 2 study testing AR882 Dose 1, AR882 Dose 2 and Allopurinol Tablet in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 12 sites in 3 countries.
Trial summary
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Arthritis, Gouty, Hyperuricemia
- What is being tested?
- AR882 Dose 1, AR882 Dose 2 and Allopurinol Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 12 Aug 2022to 28 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of gout
- at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
- 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
- Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2
Who cannot join
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- Pregnant or breastfeeding
- History of kidney stones
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
Arthrosi Investigative Site (409)
Ann Arbor, Michigan, 48109
Arthrosi Investigative Site (410)
Birmingham, Alabama, 35233
Arthrosi Investigative Site (404)
Boise, Idaho, 83713
Arthrosi Investigative Site (401)
Dallas, Texas, 75231
Arthrosi Investigative Site (406)
Greensboro, North Carolina, 27410
Arthrosi Investigative Site (408)
Myrtle Beach, South Carolina, 29577
Arthrosi Investigative Site (403)
Phoenix, Arizona, 85032
Arthrosi Investigative Site (416)
Sun City, Arizona, 85351
Arthrosi Investigative Site (402)
Tampa, Florida, 33606
Arthrosi Investigative Site (417)
Tucson, Arizona, 85704
About this study
Official title: A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Being tested
- AR882 Dose 1, AR882 Dose 2, Allopurinol Tablet
- Medical subject headings
- Gout, Arthritis, Gouty, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR882 Dose 1Drug
Solid Oral Capsule
AR882 Dose 2Drug
Solid Oral Capsule
Allopurinol TabletDrug
Solid tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Allopurinol once daily for 24 weeks Receives: Drug: Allopurinol Tablet |
| Group 2 | Experimental | AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks Receives: Drug: AR882 Dose 1; Drug: AR882 Dose 2 |
| Group 3 | Experimental | AR882 Dose 1 + Allopurinol for 24 weeks Receives: Drug: AR882 Dose 1; Drug: Allopurinol Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Measured: 12 weeks
Secondary outcomes (5)
Change from baseline in tophus area at Months 3 and 6
Comparison of the treatment groups for tophus area as measured by digital calipers
Measured: 12 weeks and 24 weeks
Change from baseline in tophus crystal volume at Months 6
Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
Measured: 24 weeks
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Measured: 12 weeks
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Measured: 24 weeks
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start12 Aug 2022
- Primary completion13 Aug 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Keenan, MD, Study chair, Arthrosi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253833
- Sponsor's protocol ID
- AR882-203
- Status last verified
- Jan 2025
- First submitted
- 15 Feb 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients
- ClinicalTrials.gov ID
- NCT05253833
- Acronym / sponsor ID
- AR882-203
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Allopurinol TabletAllopurinol once daily for 24 weeks |
| Group 2 | Experimental | Drug: AR882 Dose 1, Drug: AR882 Dose 2AR882 Dose 1 x 2 weeks, then Dose 2 x 22 weeks |
| Group 3 | Experimental | Drug: AR882 Dose 1, Drug: Allopurinol TabletAR882 Dose 1 + Allopurinol for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of gout
- at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
- 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
- Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2
Key exclusion criteria (3 listed)
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- Pregnant or breastfeeding
- History of kidney stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR882 Dose 1Solid Oral Capsule | Drug | Group 2, Group 3 |
| AR882 Dose 2Solid Oral Capsule | Drug | Group 2 |
| Allopurinol TabletSolid tablet | Drug | Group 1, Group 3 |
Primary outcome
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
Time frame: 12 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 5 mg/dL at month 3
5 secondary outcomes
Change from baseline in tophus area at Months 3 and 6
Time frame: 12 weeks and 24 weeks
Change from baseline in tophus crystal volume at Months 6
Time frame: 24 weeks
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3
Time frame: 12 weeks
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6
Time frame: 24 weeks
Incidence of Adverse Events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Keenan, MD study chair
Arthrosi Therapeutics
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR882 Dose 1, AR882 Dose 2 and Allopurinol Tablet in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, New Zealand, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.