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A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

Primary Purpose

Gout

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

SHR4640

Allopurinol

About this trial

This is an interventional treatment trial for Gout

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.

Exclusion Criteria:

Subject who is pregnant or breastfeeding;
Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;
Subject with a positive test for HLA-B*5801;
Estimated glomerular filtration rate (MDRD formula) <60ml/min;
HbA1c≥8%;
Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;
Subject with kidney stones or suspicion of kidney stones;
Subject who has acute gout flares within 2 weeks before randomization;
Subject with a history of malignancy within the previous 5 years;
Subject with a history of active peptic ulcer within a year;
Subject with a history of xanthine urine.

Sites / Locations

RenJi Hospital, Shanghai JiaoTong University School Of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group A

Treatment group B

Arm Description

SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks

Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment

Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment

The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment

Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment

change value of serum uric acid from baseline at each visit within 52 weeks of treatment

proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment

serum uric acid value at each visit within 52 weeks of treatment

Full Information

NCT ID

NCT04956432

First Posted

July 7, 2021

Last Updated

August 28, 2023

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04956432

Brief Title

A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

Official Title

A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

July 17, 2024 (Anticipated)

Study Completion Date

July 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

780 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group A

Arm Type

Experimental

Arm Description

SHR4640+Allopurinol Placebo；once a day, orally, for 52 weeks

Arm Title

Treatment group B

Arm Type

Active Comparator

Arm Description

Allopurinol+ SHR4640 Placebo；once a day, orally, for 52 weeks.

Intervention Type

Drug

Intervention Name(s)

SHR4640

Intervention Description

SHR4640 Dose 1 ,tablets, QD

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Intervention Description

Allopurinol 300mg, tablets, QD

Primary Outcome Measure Information:

Title

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

Time Frame

Start of Treatment to end of study (approximately 16 weeks)

Secondary Outcome Measure Information:

Title

Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 16 weeks)

Title

Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 16 weeks)

Title

The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 16 weeks)

Title

Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 52 weeks)

Title

change value of serum uric acid from baseline at each visit within 52 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 52 weeks)

Title

proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 52 weeks)

Title

serum uric acid value at each visit within 52 weeks of treatment

Time Frame

Start of Treatment to end of study (approximately 52 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2. Exclusion Criteria: Subject who is pregnant or breastfeeding; Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit; Subject with a positive test for HLA-B*5801; Estimated glomerular filtration rate (MDRD formula) <60ml/min; HbA1c≥8%; Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640; Subject with kidney stones or suspicion of kidney stones; Subject who has acute gout flares within 2 weeks before randomization; Subject with a history of malignancy within the previous 5 years; Subject with a history of active peptic ulcer within a year; Subject with a history of xanthine urine.

Facility Information:

Facility Name

RenJi Hospital, Shanghai JiaoTong University School Of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout

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