Clinical trial NCT06603142: Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Primary Gout
Hyperuricemia
Keywords: ULT
Gout
Hyperuricemia
URAT1
Lead sponsor: Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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\&lt;3.0×109/L，Hb\&lt;90g/L，PLT\&lt;80×109/L，ASTorALT\&gt;1.5×ULN，TBIL\&gt;1.5×ULN，Scr\&gt;1.5×ULN，eGFR\&lt;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;amp;gt;100 mg/day or unstable dosage within 2 weeks prior to randomization；
* Use of any diuretics within 2 weeks prior to randomization；
* 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\&amp;#39;s formula) prolongation (male \&amp;gt;450 ms, female \&amp;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 \&amp;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

Primary outcomes:
measure: The percentage of participants with serum uric acid &lt;360 μmol/L
timeFrame: 8 Weeks
Secondary outcomes:
measure: The percentage of participants with serum uric acid &lt;300, 240 μmol/L
timeFrame: 8 Weeks
measure: The percentage of participants with serum uric acid &lt;360, 300, 240 μmol/L
timeFrame: 2, 4, and 6 Weeks
measure: The absolute change in serum uric acid levels from baseline
timeFrame: 2, 4, 6, and 8 Weeks
measure: The percentage change in serum uric acid levels from baseline
timeFrame: 2, 4, 6, and 8 Weeks
measure: Serum uric acid levels
timeFrame: 2, 4, 6, and 8 Weeks
measure: Adverse events
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science
Study officials:
References: