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

Study on Efficacy and Safety of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gout With Hyperuricemia in Adults
• Intervention / Treatment: Drug: HR091506 tablets + placebo of febuxostat tablets; Drug: febuxostat tablets + placebo of HR091506 tablets

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ninghui Yan; Phone Number: +0518-82342973; Email: ninghui.yan@hengrui.com
• Study Contact Backup: Name: Jing Xu; Phone Number: +0518-82342973; Email: jing.xu.jx23@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HR091506 tablets + placebo of febuxostat tablets	Drug: HR091506 tablets + placebo of febuxostat tablets; HR091506 tablets 20mg qd + placebo of febuxostat tablets 20mg qd from Week 1 to 4, HR091506 tablets 40mg qd + placebo of febuxostat tablets 40mg qd from Week 5 to 28.
Active Comparator: Treatment group B: febuxostat tablets + placebo of HR091506 tablets	Drug: febuxostat tablets + placebo of HR091506 tablets; febuxostat tablets 20mg qd + placebo of HR091506 tablets 20mg qd from Week 1 to 4, febuxostat tablets 40mg qd + placebo of HR091506 tablets 40mg qd from Week 5 to 28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with serum uric acid level < 360 μmoL/L at Week 28	Week 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with serum uric acid level < 360 μmol/L at each visit.	at week 4,8,12,16,20and24 after administration
Proportion of subjects with serum uric acid level < 300 μmol/L at each visit	at week 4,8,12,16,20and24 after administration
Change of serum uric acid level from baseline to every visit	at week 4,8,12,16,20and24 after administration
Proportion of subjects with ≥1 gout flare during treatment stage	during treatment stage

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: HR091506-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No