Clinical trial NCT06139393: Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Official title: Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gout With Hyperuricemia in Adults
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 750
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 study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.


Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, male or female;
2. BMI: 18.0-30.0 kg/m2;
3. Meet the 2015 ACR/EULAR gout classification criteria;
4. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
5. Willing to ues contraceptive measures during the study;
6. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. History of acute gout attack within 4 weeks before randomization.
2. Subjects who have undergone major surgery or organ transplantation within 3 months before randomization.
3. Subjects with major cardiovascular disease within 6 months before randomization.
4. History of chronic infection or recurrent infection within 1year before randomization.
5. History of malignant tumor or current history of combined malignant tumor within 5 years before screening.
6. History of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder.
7. Subjects with poorly controlled blood pressure or diabetes mellitus.
8. History of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease.
9. History of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research.
10. Abnormal laboratory tests that may affect subjects participating in the research.
11. Combined use of prohibited drugs.
12. Allergic to ingredient or component of the experimental drug.
13. Participated in other clinical trials within 1 month before randomization.
14. Pregnant or nursing women.
15. History of drug abuse, drug use and/or excessive drinking within 1 year before screening.
16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.

Primary outcomes:
measure: The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28
timeFrame: Week 28
Secondary outcomes:
measure: Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.
timeFrame: at week 4,8,12,16,20and24 after administration
measure: Proportion of subjects with serum uric acid level < 300 μmol/L at each visit
timeFrame: at week 4,8,12,16,20and24 after administration
measure: Change of serum uric acid level from baseline to every visit
timeFrame: at week 4,8,12,16,20and24 after administration
measure: Proportion of subjects with ≥1 gout flare during treatment stage
timeFrame: during treatment stage
Other outcomes:
Locations:
Study officials:
References: