Primary GoutPhase 2/3NCT06603142
Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
A Phase 2/3 study testing Febuxostat 20MG Tablets, AR882 25MG and AR882 12.5MG in people with Primary Gout and Hyperuricemia, run by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are: What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia? Researchers will… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Gout, Hyperuricemia
- What is being tested?
- Febuxostat 20MG Tablets, AR882 25MG and AR882 12.5MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to Apr 2026
- Phase
- Phase 2/3
- 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
- Male or female patients ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)；
- History of gout according to the 2015 American College Rheumatology/European League Against Rheumatism (ACR/EULAR) Gout Classification Criteria，with serum urate (sUA) levels ≥480μmol/L；
- Body mass index (BMI) must be within the range of ≥ 18 to ≤ 35 kg/m2；
- Participants with childbearing potential must agree to use medically accepted effective contraception during the study period and for 3 months after the last dose
- Willing to participate in the study and sign the informed consent form.
Who cannot join
- Known or suspected allergy to the study drug or its components, or previous intolerance or contraindications to febuxostat；
- HbA1c ≥8% within 2 weeks prior to randomization；
- Any of the following laboratory test results within 2 weeks prior to randomization：WBC\<3.0×109/L，Hb\<90g/L，PLT\<80×109/L，ASTorALT\>1.5×ULN，TBIL\>1.5×ULN，Scr\>1.5×ULN，eGFR\<60mL/min/1.73m2；
- Use of any other uric acid-lowering drugs or concomitant medications affecting uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4 inhibitors, SGLT2 inhibitors, metformin) within 2 weeks prior to randomization, except for stable dose usage；
- Use of aspirin \&amp;gt;100 mg/day or unstable dosage within 2 weeks prior to randomization；
- Use of any diuretics within 2 weeks prior to randomization；
Show all 26Show fewer
- Use of a strong or moderate CYP2C9 inhibitor or BCRP substrate drugs (see Appendix 2) within 2 weeks prior to randomization；
- Secondary hyperuricemia due to tumors, chronic kidney disease, hematological diseases, medications, or hereditary hyperuricemia；
- Presence of unresolved gout attacks within 2 weeks prior to randomization；
- Imaging or clinical manifestations (e.g., hematuria, back pain) of kidney stones or urolithiasis within 2 weeks prior to randomization；
- Other joint lesions that may confound gouty arthritis, such as rheumatoid arthritis, septic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or joint diseases caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.;
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin and resected cervical intraepithelial neoplasia that has been successfully treated；
- Severe cardiovascular or cerebrovascular diseases, such as New York Heart Association (NYHA) Class III-IV congestive heart failure, uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), QTcF interval (Fridericia\&#39;s formula) prolongation (male \&gt;450 ms, female \&gt;470 ms), myocardial infarction, acute stroke, uncontrolled arrhythmia, or unstable angina within 12 months prior to screening；
- Unable to swallow oral medications or have gastrointestinal diseases that may interfere with drug absorption, or have active gastric or duodenal ulcers within 3 months prior to screening；
- Systemic diseases requiring immunosuppressive therapy, or vaccination within 2 weeks prior to randomization；
- Other severe or uncontrolled diseases；
- History of xanthinuria；
- Poor compliance (e.g., alcoholism, drug abuse) that may affect the safety and efficacy evaluation of the study drug, as judged by the investigator；
- Pregnant or breastfeeding women；
- Any acute inflammation or clinically significant active infection；
- Active hepatitis B (HBsAg positive and HBV-DNA \&gt;1000 IU/mL), or positive for serum HCV antibodies, HIV antibodies, or syphilis antibodies；
- Previous kidney removal and/or kidney transplantation；
- Major surgery within 3 months prior to randomization, or planned major surgery during the study；
- Blood donation (or blood loss) ≥400 mL or blood transfusion within 3 months prior to randomization；
- Participation in another drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational product (whichever is longer), or participation in a medical device clinical trial within 3 months prior to screening；
- Any other condition deemed unsuitable for study participation by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Science
Beijing, 100730
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are:
What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia?
Read more
Researchers will compare AR882 Capsules with Febuxostat Tablets to see :
Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia.
Participants will:
Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.
- Conditions
- Primary Gout, Hyperuricemia
- Being tested
- Febuxostat 20MG Tablets, Febuxostat 20MG Placebo, AR882 25MG, AR882 12.5MG, AR882 25MG Placebo
- Keywords
- ULT, Gout, Hyperuricemia, 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.
Febuxostat 20MG TabletsDrug
Febuxostat 20MG Tablets
Febuxostat 20MG PlaceboDrug
Febuxostat 20MG Placebo
AR882 25MGDrug
AR882 25 MG Capsules
AR882 12.5MGDrug
AR882 12.5 MG Capsules
AR882 25MG PlaceboDrug
AR882 25MG Placebo
AR882 12.5MG PlaceboDrug
AR882 12.5MG Placebo
Febuxostat 40MG TabletsDrug
Febuxostat 40MG Tablets
Febuxostat 40MG PlaceboDrug
Febuxostat 40MG Placebo
| Study group | Role | What they receive |
|---|---|---|
| AR882 50MG | Experimental | Titrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo. Receives: Drug: Febuxostat 20MG Placebo; Drug: AR882 25MG; Drug: AR882 12.5MG; Drug: Febuxostat 40MG Placebo |
| Febuxostat 40MG | Active comparator | Titrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo. Receives: Drug: Febuxostat 20MG Tablets; Drug: AR882 25MG Placebo; Drug: AR882 12.5MG Placebo; Drug: Febuxostat 40MG Tablets |
| AR882 75MG | Experimental | Titrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo. Receives: Drug: Febuxostat 20MG Placebo; Drug: AR882 25MG; Drug: Febuxostat 40MG Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants with serum uric acid <360 μmol/L
Measured: 8 Weeks
Secondary outcomes (6)
The percentage of participants with serum uric acid <300, 240 μmol/L
Measured: 8 Weeks
The percentage of participants with serum uric acid <360, 300, 240 μmol/L
Measured: 2, 4, and 6 Weeks
The absolute change in serum uric acid levels from baseline
Measured: 2, 4, 6, and 8 Weeks
The percentage change in serum uric acid levels from baseline
Measured: 2, 4, 6, and 8 Weeks
Serum uric acid levels
Measured: 2, 4, 6, and 8 Weeks
Adverse events
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start22 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 636 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603142
- Sponsor's protocol ID
- APRAB-H001-P301
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase II/III Study to Evaluate the Efficacy and Safety of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
- ClinicalTrials.gov ID
- NCT06603142
- Acronym / sponsor ID
- APRAB-H001-P301
- Conditions
- Primary Gout, Hyperuricemia
- Keywords
- ULT, Gout, Hyperuricemia, URAT1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 636 participants (estimated)
- Lead sponsor
- Guangzhou Ruianbo Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia. The main questions it aims to answer are:
What is the efficacy of AR882 Capsules in reducing serum uric acid levels in patients with primary gout and hyperuricemia?
Researchers will compare AR882 Capsules with Febuxostat Tablets to see :
Phase II: To explore the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia, aiming to determine the dosing regimen for the Phase III study Phase III: To evaluate the efficacy of AR882 Capsules in patients with primary gout and hyperuricemia.
Participants will:
Be randomly assigned to receive either AR882 Capsules or Febuxostat Tablets. Undergo regular assessments of serum uric acid levels. Report any adverse events or side effects experienced during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR882 50MG | Experimental | Drug: Febuxostat 20MG Placebo, Drug: AR882 25MG, Drug: AR882 12.5MG, Drug: Febuxostat 40MG PlaceboTitrated from 12.5 mg to 25 mg (2 weeks each), then 50 mg for 4 weeks, with matching Febuxostat placebo. |
| Febuxostat 40MG | Active comparator | Drug: Febuxostat 20MG Tablets, Drug: AR882 25MG Placebo, Drug: AR882 12.5MG Placebo, Drug: Febuxostat 40MG TabletsTitrated from 20 mg (4 weeks) to 40 mg (4 weeks) Febuxostat, with matching AR882 placebo. |
| AR882 75MG | Experimental | Drug: Febuxostat 20MG Placebo, Drug: AR882 25MG, Drug: Febuxostat 40MG PlaceboTitrated from 25 mg to 50 mg (2 weeks each), then 75 mg for 4 weeks, with matching Febuxostat placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)；
- History of gout according to the 2015 American College Rheumatology/European League Against Rheumatism (ACR/EULAR) Gout Classification Criteria，with serum urate (sUA) levels ≥480μmol/L；
- Body mass index (BMI) must be within the range of ≥ 18 to ≤ 35 kg/m2；
- Participants with childbearing potential must agree to use medically accepted effective contraception during the study period and for 3 months after the last dose
- Willing to participate in the study and sign the informed consent form.
Key exclusion criteria (26 listed)
- Known or suspected allergy to the study drug or its components, or previous intolerance or contraindications to febuxostat；
- HbA1c ≥8% within 2 weeks prior to randomization；
- Any of the following laboratory test results within 2 weeks prior to randomization：WBC\<3.0×109/L，Hb\<90g/L，PLT\<80×109/L，ASTorALT\>1.5×ULN，TBIL\>1.5×ULN，Scr\>1.5×ULN，eGFR\<60mL/min/1.73m2；
- Use of any other uric acid-lowering drugs or concomitant medications affecting uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4 inhibitors, SGLT2 inhibitors, metformin) within 2 weeks prior to randomization, except for stable dose usage；
- Use of aspirin \&amp;gt;100 mg/day or unstable dosage within 2 weeks prior to randomization；
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 |
|---|---|---|
| Febuxostat 20MG TabletsFebuxostat 20MG Tablets | Drug | Febuxostat 40MG |
| Febuxostat 20MG PlaceboFebuxostat 20MG Placebo | Drug | AR882 50MG, AR882 75MG |
| AR882 25MGAR882 25 MG Capsules | Drug | AR882 50MG, AR882 75MG |
| AR882 12.5MGAR882 12.5 MG Capsules | Drug | AR882 50MG |
| AR882 25MG PlaceboAR882 25MG Placebo | Drug | Febuxostat 40MG |
| AR882 12.5MG PlaceboAR882 12.5MG Placebo | Drug | Febuxostat 40MG |
| Febuxostat 40MG TabletsFebuxostat 40MG Tablets | Drug | Febuxostat 40MG |
| Febuxostat 40MG PlaceboFebuxostat 40MG Placebo | Drug | AR882 50MG, AR882 75MG |
Primary outcome
The percentage of participants with serum uric acid <360 μmol/L
Time frame: 8 Weeks
6 secondary outcomes
The percentage of participants with serum uric acid <300, 240 μmol/L
Time frame: 8 Weeks
The percentage of participants with serum uric acid <360, 300, 240 μmol/L
Time frame: 2, 4, and 6 Weeks
The absolute change in serum uric acid levels from baseline
Time frame: 2, 4, 6, and 8 Weeks
The percentage change in serum uric acid levels from baseline
Time frame: 2, 4, 6, and 8 Weeks
Serum uric acid levels
Time frame: 2, 4, 6, and 8 Weeks
Adverse events
Time frame: 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Gout
RecruitingPhase 2
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
Primary Gout and Hyperuricemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Febuxostat 20MG Tablets, AR882 25MG and AR882 12.5MG in people with Primary Gout and Hyperuricemia, run by Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd at 1 site in China.
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 26 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The percentage of participants with serum uric acid <360 μmol/L (time frame: 8 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 19 Sep 2024.