GoutPhase 2NCT05119686
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
A Phase 2 study testing AR882 Dose 1 and AR882 Dose 2 in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 23 sites in 3 countries.
Trial summary
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 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 and AR882 Dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 16 Nov 2021to 17 Nov 2022
- 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
- sUA > 7 mg/dL
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2
Who cannot join
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- History of kidney stones
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States16 sites
Arthrosi Investigative Site
Cleveland, Ohio, 44122
Arthrosi Investigative Site
Cleveland, Ohio, 44195
Arthrosi Investigative Site
Dallas, Texas, 75231
Arthrosi Investigative Site
Duncansville, Pennsylvania, 16635
Arthrosi Investigative Site
Gilbert, Arizona, 85297
Arthrosi Investigative Site
Glendale, Wisconsin, 53217
Arthrosi Investigative Site
Honolulu, Hawaii, 96814
Arthrosi Investigative Site
Houston, Texas, 77074
Arthrosi Investigative Site
Miami, Florida, 33143
Arthrosi Investigative Site
Miami Lakes, Florida, 33014
Arthrosi Investigative Site
Overland Park, Kansas, 66212
Arthrosi Investigative Site
Sun City, Arizona, 85351
Arthrosi Investigative Site
Tampa, Florida, 33613
Arthrosi Investigative Site
Tomball, Texas, 77375
Arthrosi Investigative Site
Tucson, Arizona, 85704
Arthrosi Investigative Site
West Jordan, Utah, 84088
Taiwan5 sites
Arthrosi Investigative Site
Taichung, 402
Arthrosi Investigative Site - 301
Taipei, 112
Arthrosi Investigative Site - 304
Taipei, 112
Arthrosi Investigative Site
Taipei, 114
Arthrosi Investigative Site
Taoyuan, 333
Australia2 sites
Arthrosi investigative Site
Botany, New South Wales, 2019
Arthrosi Investigative Site
Melbourne, Camberwell, 3124
About this study
Official title: A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Being tested
- AR882 Dose 1, AR882 Dose 2, Placebo
- 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
PlaceboDrug
Matching Solid Oral Capsule Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AR882 Dose 1 x 12 weeks Receives: Drug: AR882 Dose 1 |
| Group 2 | Experimental | AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks Receives: Drug: AR882 Dose 1; Drug: AR882 Dose 2 |
| Group 3 | Placebo comparator | AR882 matching placebo x 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
Measured: 6 weeks
Secondary outcomes (5)
sUA levels < 5, < 4, and < 3 mg/dL
Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL
Measured: 6 weeks
Incidence of Adverse Events
Treatment Emergent Adverse Events and Serious Adverse Event incidence.
Measured: 14 weeks
Maximum Observed Plasma Concentration (Cmax)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax.
Measured: 12 weeks
Time to observed Cmax (Tmax)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax.
Measured: 12 weeks
Area under the plasma concentration-time curve (AUC)
Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start16 Nov 2021
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 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
- NCT05119686
- Sponsor's protocol ID
- AR882-202
- Status last verified
- May 2023
- First submitted
- 20 Oct 2021
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients
- ClinicalTrials.gov ID
- NCT05119686
- Acronym / sponsor ID
- AR882-202
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 15 Nov 2021 (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 uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: AR882 Dose 1AR882 Dose 1 x 12 weeks |
| Group 2 | Experimental | Drug: AR882 Dose 1, Drug: AR882 Dose 2AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks |
| Group 3 | Placebo comparator | Drug: PlaceboAR882 matching placebo x 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of gout
- sUA > 7 mg/dL
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 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
- History of cardiac abnormalities
- 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 1, Group 2 |
| AR882 Dose 2Solid Oral Capsule | Drug | Group 2 |
| PlaceboMatching Solid Oral Capsule Placebo | Drug | Group 3 |
Primary outcome
Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
Time frame: 6 weeks
Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing
5 secondary outcomes
sUA levels < 5, < 4, and < 3 mg/dL
Time frame: 6 weeks
Incidence of Adverse Events
Time frame: 14 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: 12 weeks
Time to observed Cmax (Tmax)
Time frame: 12 weeks
Area under the plasma concentration-time curve (AUC)
Time frame: 12 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 12 May 2023.
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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
23 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 and AR882 Dose 2 in people with Gout and Arthritis, Gouty, run by Arthrosi Therapeutics at 23 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 3 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Taiwan, Australia. 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. Some participants in this study may receive a placebo. 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 < 6 mg/dL following 6 weeks of dosing (time frame: 6 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 12 May 2023.