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

Last updated: May 10, 2024
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Musculoskeletal Diseases

Treatment

febuxostat tablets + placebo of HR091506 tablets

HR091506 tablets + placebo of febuxostat tablets

Clinical Study ID

NCT06414837
HR091506-301
  • Ages 18-75
  • All Genders

Study 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

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

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 monthsbefore randomization.

  3. Subjects with major cardiovascular disease within 6 months before randomization.

  4. History of chronic infection or recurrent infection within 1year beforerandomization.

  5. History of malignant tumor or current history of combined malignant tumor within 5years before screening.

  6. History of secondary hyperuricemia, refractory gout, or xanthine metabolismdisorder.

  7. Subjects with poorly controlled blood pressure or diabetes mellitus.

  8. History of chronic diffuse connective tissue disease and/or massively elevated uratediseases and/or untreated clinically significant thyroid disease.

  9. History of diseases that may affect the in vivo process, safety evaluation, orsubjects' 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 beforescreening.

  16. The inestigators determined that other conditions were inappropriate forparticipation in this clinical trial.

Study Design

Total Participants: 434
Treatment Group(s): 2
Primary Treatment: febuxostat tablets + placebo of HR091506 tablets
Phase: 3
Study Start date:
June 01, 2024
Estimated Completion Date:
June 30, 2026