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Status unknownNCT06414837Updated May 16, 2024

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

A Phase 3 interventional study of HR091506 tablets + placebo of febuxostat tablets and febuxostat tablets + placebo of HR091506 tablets in Gout With Hyperuricemia in Adults, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
434
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Gout With Hyperuricemia in Adults
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 571 studies on the registry; 86 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
434 participants (estimated)

Study arms

  • Experimental
    Treatment group A: HR091506 tablets + placebo of febuxostat tablets

    Drug: HR091506 tablets + placebo of febuxostat tablets

  • Active comparator
    Treatment group B: febuxostat tablets + placebo of HR091506 tablets

    Drug: febuxostat tablets + placebo of HR091506 tablets

Interventions

  • DrugHR091506 tablets + placebo of febuxostat tablets

    HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd, from Week 1 to 36.

  • Drugfebuxostat tablets + placebo of HR091506 tablets

    febuxostat tablets 20mg/ 40mg/ 60mg/80mg qd + placebo of HR091506 tablets 20mg/ 40mg/ 60mg/80mg qd . from Week 1 to 36.

06

What researchers measure

Primary outcomes

  1. The proportion of subjects with serum uric acid level < 300 μmoL/L at Week 36

    Time frame: Week 36

Secondary outcomes

  1. Proportion of subjects with serum uric acid level < 360 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration

    Time frame: at week 4,8,12,16,20,24,28,32,36 after administration

  2. Proportion of subjects with serum uric acid level < 300 μmol/L at week 4,8,12,16,20,24,28,32,36 after administration

    Time frame: at week 4,8,12,16,20,24,28,32,36 after administration

  3. Change of serum uric acid level from baseline week 4,8,12,16,20,24,28,32,36 after administration

    Time frame: week 4,8,12,16,20,24,28,32,36 after administration

  4. Proportion of subjects with ≥1 gout flare during the 36 weeks treatment stage

    Time frame: during the 36 weeks treatment stage

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06414837
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 16, 2024
Start date
Jun 2024 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
May 16, 2024

Study contacts

Ninghui Yan
Contact
ninghui.yan@hengrui.com
+0518-82342973
Jing Xu
Contact
jing.xu.jx23@hengrui.com
+0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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