Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia

NCT05513976 | Unknown Phase 2

• 1 other identifier: SHR4640-203
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with placebo and febuxostat in primary gout and hyperuricemia subjects with inadequate control on febuxostat for 12 weeks.

Conditions

Primary Gout and Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with serum uric acid ≤360μmol/L

  After 12 weeks of treatment

Secondary Outcomes (5)

• Proportion of subjects with serum uric acid ≤ 300μmol/L (response)

  After 12 weeks of treatment

• Proportion of subjects with serum uric acid ≤360μmol/L at the last two tests at 12 weeks of double-blind treatment

  After 12 weeks of treatment

• Percentage change in serum uric acid from baseline at each visit

  within 12 weeks of double-blind treatment

• Changes in serum uric acid from baseline at each visit

  within 12 weeks of double-blind treatment

• Proportion of subjects with serum uric acid ≤360μmol/L at each visit

  within 12 weeks of double-blind treatment

Study Arms (3)

treatment group A

EXPERIMENTAL

Drug: SHR4640 tablet; Drug: febuxostat tablet

treatment group B

EXPERIMENTAL

Drug: SHR4640 tablet; Drug: febuxostat tablet

treatment group C

PLACEBO COMPARATOR

Drug: febuxostat tablet; Drug: SHR4640 placebo tablet

Interventions

SHR4640 tablet DRUG

SHR4640 tablet 5mg

treatment group A

febuxostat tablet DRUG

febuxostat tablet 40mg or 60mg or 80mg based on prior medication

treatment group A; treatment group B; treatment group C

SHR4640 placebo tablet DRUG

SHR4640 placebo tablet 5 or 10mg

treatment group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
• The screening age should be 18-65 years old (including both ends), male or female; 3. Receiving febuxostat dose ≥40mg/ day, not more than 80mg/ day, stable dose for ≥6 weeks, fasting serum uric acid ≥390µmol/L at screening; 4. Meet the 1977 or 2015 American College of Rheumatology (ACR) criteria for classification of gout; 5、18kg/m2≤ Body weight Mass index (BMI) ≤35kg/m2.

You may not qualify if:

• General Situation:
• \) Pregnant or lactating women;
• \) Refusal or use of medically unapproved contraceptive measures by fertile women or men (except for non-fertile partners) within 3 months of screening to the last medication for men and 6 months for women;
• \) The average daily alcohol intake in the 1 month prior to screening was more than 14g (e.g., 145mL wine, 497mL beer, or 43mL low-alcohol liquor) for women and more than 28g (e.g., 290mL wine, 994mL beer, or 86mL low-alcohol liquor) for men;
• \) Drug abusers;
• \) Subjects whose compliance is considered by the investigator to be poor and affect the evaluation of the safety and efficacy of the trial drug.
• The following conditions occurred in the laboratory examination within 3 weeks before randomization:
• \) upper limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (T-Bil);
• \) Serum creatinine was calculated using simplified Diet adjustment for Kidney Disease (MDRD) formula and eGFR was less than 45mL/ (min×1.73m2).
• \) Glycosylated hemoglobin (HbA1c) ≥8%;
• \) Having active hepatitis B \[hepatitis B surface antigen (HBsAg) positive and HBV deoxyribonucleic acid (HBV-DNA) ≥500 IU/mL or 2500 copies/mL\], or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, Or a positive syphilis antibody test;
• \) White blood cell \< 3.0×109/L, and/or hemoglobin \< 90 g/L, and/or platelet \< 80×109/L.
• Any of the following medical history or comorbidities:
• \) Allergy, allergy to SHR4640 or any component of SHR4640, or previous intolerance to febuxostat or contraindications;
• \) Secondary hyperuricemia caused by tumors, chronic kidney diseases, blood diseases, drugs and other reasons;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Hyperuricemia

Interventions

ruzinurad; Febuxostat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Wangwang Zhi

CONTACT

+86 18036618683; Wangwang.zhi@hengrui.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR4640 VS. Placebo

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 15, 2022
• Primary Completion: May 30, 2023
• Study Completion: September 20, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08