Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Gout With Hyperuricemia in Adults

Treatments: Drug: febuxostat tablets + placebo of HR091506 tablets; Drug: HR091506 tablets + placebo of febuxostat tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06414837

HR091506-301

Details and patient eligibility

About

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.

Enrollment: 434 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-75 years old, male or female;
2. Meet the 2015 ACR/EULAR gout classification criteria;
3. Fast serum uric acid ≥ 480 μmol/L on 2 different days during the screening perid;
4. Patients with tophi, chronic arthropathy, frequent attacks;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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434 participants in 2 patient groups

Treatment group A: HR091506 tablets + placebo of febuxostat tablets

Experimental group

Treatment:

Drug: HR091506 tablets + placebo of febuxostat tablets

Treatment group B: febuxostat tablets + placebo of HR091506 tablets

Active Comparator group

Treatment:

Drug: febuxostat tablets + placebo of HR091506 tablets