Gout PatientsPhase 2NCT04155918
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
A Phase 2 study testing Group 1: AR882 Alone and in Combination with Febuxostat (FBX) and Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) in people with Gout Patients, run by Arthrosi Therapeutics at 1 site in New Zealand.
Trial summary
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout Patients
- What is being tested?
- Group 1: AR882 Alone and in Combination with Febuxostat (FBX) and Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- 3 Feb 2020to 3 Sep 2020
- 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 65 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) ≥ 60 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
- Active peptic ulcer disease or active liver disease
- History of kidney stones
- Allergy or intolerance to colchicine, febuxostat, and allopurinol
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Clinical Studies Trust, Ltd (CCST)
Christchurch
About this study
Official title: A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.
- Conditions
- Gout Patients
- Being tested
- Group 1: AR882 Alone and in Combination with Febuxostat (FBX), Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
- Keywords
- Hyperuricemia, Gout, URAT1
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: AR882 Alone and in Combination with Febuxostat (FBX)Drug
Also called Febuxostat (Adenuric®, Uloric®)
AR882 + Febuxostat, AR882 alone, Febuxostat alone
Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)Drug
Also called Allopurinol (Allosig®, Progout®, Zyloprim®)
AR882 + Allopurinol, AR882 alone, Allopurinol alone
| Study group | Role | What they receive |
|---|---|---|
| AR882/FBX | Experimental | Not described Receives: Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX) |
| AR882/ALLO | Experimental | Not described Receives: Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD profile of AR882 administered alone or in combination with febuxostat
Profile from serum uric acid concentration over time
Measured: 22 Days
PD profile of AR882 administered alone or in combination with allopurinol
Profile from serum uric acid concentration over time.
Measured: 22 Days
Serum uric acid (sUA) response rate
sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL
Measured: 22 Days
Secondary outcomes (21)
Area under the curve (AUC) for plasma AR882
Profile from plasma in terms of AUC for AR882
Measured: 22 Days
Time to maximum plasma concentration (Tmax) for AR882
Profile from plasma in terms of Tmax for AR882
Measured: 22 Days
Maximum plasma concentration (Cmax) for AR882
Profile from plasma in terms of Cmax for AR882
Measured: 22 Days
Apparent terminal half-life (t1/2) for AR882
Profile from plasma in terms of t1/2 for AR882
Measured: 22 Days
Amount excreted (Ae) into urine for AR882
Profile from urine in terms of Ae for AR882
Measured: 22 Days
Renal clearance (CLr) for AR882
Profile from urine in terms of CLr for AR882
Measured: 22 Days
AUC for plasma for febuxostat
Profile from plasma in terms of AUC for febuxostat
Measured: 22 Days
Tmax for febuxostat
Profile from plasma in terms of Tmax for febuxostat
Measured: 22 Days
Cmax for febuxostat
Profile from plasma in terms of Cmax for febuxostat
Measured: 22 Days
t1/2 for febuxostat
Profile from plasma in terms of t1/2 for febuxostat
Measured: 22 Days
AUC for plasma allopurinol/oxypurinol
Profile from plasma in terms of AUC for allopurinol/oxypurinol
Measured: 22 Days
Tmax for allopurinol/oxypurinol
Profile from plasma in terms of Tmax for allopurinol/oxypurinol
Measured: 22 Days
Cmax for allopurinol/oxypurinol
Profile from plasma in terms of Cmax for allopurinol/oxypurinol
Measured: 22 Days
t1/2 for for allopurinol/oxypurinol
Profile from plasma in terms of t1/2 for allopurinol/oxypurinol
Measured: 22 Days
Ae in urine for allopurinol/oxypurinol
Profile from urine in terms of Ae for allopurinol/oxypurinol
Measured: 22 Days
CLr for allopurinol/oxypurinol
Profile from urine in terms of CLr for allopurinol/oxypurinol
Measured: 22 Days
AUC for plasma for colchicine
Profile from plasma in terms of AUC for colchicine
Measured: 22 Days
Tmax for colchicine
Profile from plasma in terms of Tmax for colchicine
Measured: 22 Days
Cmax for colchicine
Profile from plasma in terms of Cmax for colchicine
Measured: 22 Days
t1/2 for for colchicine
Profile from plasma in terms of t1/2 for colchicine
Measured: 22 Days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start3 Feb 2020
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout PatientsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrosi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Wynne, MBChB, Grad Dip Pharm Med, Principal investigator, Christchurch Clinical Studies Trust Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155918
- Sponsor's protocol ID
- AR882-201
- Status last verified
- Nov 2020
- First submitted
- 25 Oct 2019
- Last updated
- 19 Nov 2020
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients
- ClinicalTrials.gov ID
- NCT04155918
- Acronym / sponsor ID
- AR882-201
- Conditions
- Gout Patients
- Keywords
- Hyperuricemia, Gout, URAT1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Arthrosi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 7 Nov 2019 (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.
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR882/FBX | Experimental | Drug: Group 1: AR882 Alone and in Combination with Febuxostat (FBX) |
| AR882/ALLO | Experimental | Drug: Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) |
Who may qualify
- Ages
- 18 to 65 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) ≥ 60 mL/min/1.73m2
Key exclusion criteria (5 listed)
- Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- History of cardiac abnormalities
- Active peptic ulcer disease or active liver disease
- History of kidney stones
- Allergy or intolerance to colchicine, febuxostat, and allopurinol
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 |
|---|---|---|
| Group 1: AR882 Alone and in Combination with Febuxostat (FBX)Also: Febuxostat (Adenuric®, Uloric®)AR882 + Febuxostat, AR882 alone, Febuxostat alone | Drug | AR882/FBX |
| Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)Also: Allopurinol (Allosig®, Progout®, Zyloprim®)AR882 + Allopurinol, AR882 alone, Allopurinol alone | Drug | AR882/ALLO |
Primary outcome
PD profile of AR882 administered alone or in combination with febuxostat
Time frame: 22 Days
Profile from serum uric acid concentration over time
PD profile of AR882 administered alone or in combination with allopurinol
Time frame: 22 Days
Profile from serum uric acid concentration over time.
Serum uric acid (sUA) response rate
Time frame: 22 Days
sUA response rate to achieve sUA <6, <5, <4, and <3 mg/dL
21 secondary outcomes
Area under the curve (AUC) for plasma AR882
Time frame: 22 Days
Time to maximum plasma concentration (Tmax) for AR882
Time frame: 22 Days
Maximum plasma concentration (Cmax) for AR882
Time frame: 22 Days
Apparent terminal half-life (t1/2) for AR882
Time frame: 22 Days
Amount excreted (Ae) into urine for AR882
Time frame: 22 Days
Renal clearance (CLr) for AR882
Time frame: 22 Days
AUC for plasma for febuxostat
Time frame: 22 Days
Tmax for febuxostat
Time frame: 22 Days
Cmax for febuxostat
Time frame: 22 Days
t1/2 for febuxostat
Time frame: 22 Days
AUC for plasma allopurinol/oxypurinol
Time frame: 22 Days
Tmax for allopurinol/oxypurinol
Time frame: 22 Days
Cmax for allopurinol/oxypurinol
Time frame: 22 Days
t1/2 for for allopurinol/oxypurinol
Time frame: 22 Days
Ae in urine for allopurinol/oxypurinol
Time frame: 22 Days
CLr for allopurinol/oxypurinol
Time frame: 22 Days
AUC for plasma for colchicine
Time frame: 22 Days
Tmax for colchicine
Time frame: 22 Days
Cmax for colchicine
Time frame: 22 Days
t1/2 for for colchicine
Time frame: 22 Days
Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs
Time frame: 28 Days
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 19 Nov 2020.
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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.
Christopher Wynne, MBChB, Grad Dip Pharm Med principal investigator
Christchurch Clinical Studies Trust Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group 1: AR882 Alone and in Combination with Febuxostat (FBX) and Group 2: AR882 Alone and in Combination with Allopurinol (ALLO) in people with Gout Patients, run by Arthrosi Therapeutics at 1 site in New Zealand.
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 5 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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?
PD profile of AR882 administered alone or in combination with febuxostat (time frame: 22 Days). The study lists 3 primary outcomes in all. 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 19 Nov 2020.