Back to results

A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout

Primary Purpose

Gout

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

SHR4640 dose1

SHR4640 dose2

Placebo oral tablet

Allopurinol 300 MG

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;
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 allopurinal, 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 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

SHR4640 dose1

SHR4640 dose2

Allopurinol

Arm Description

Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks

SHR4640 dose1 once a day, orally, for 36 weeks

SHR4640 dose2 once a day, orally, for 36 weeks

Allopurinol 300mg (milligram) once a day, Orally, for 36 week

Outcomes

Primary Outcome Measures

Proportion of subjects with a serum uric level≤360μmol/l.

Secondary Outcome Measures

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

Percentage change from baseline in serum uric level

Actual change from baseline in serum uric level

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

Full Information

NCT ID

NCT04052932

First Posted

August 6, 2019

Last Updated

June 9, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04052932

Brief Title

A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout

Official Title

A Phase3, Multicentre, Randomized, Double-Blind, Allopurinol and Placebo-Controlled Study to Evaluate the Efficacy and Safety of SHR4640 Monotherapy in Subjects With Gout

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 16, 2019 (Actual)

Primary Completion Date

July 14, 2021 (Actual)

Study Completion Date

July 14, 2021 (Actual)

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

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to placebo and Allopurinol in patients 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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

594 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo once a day, orally, for 12 weeks, followed by SHR4640 treatment to 36 weeks

Arm Title

SHR4640 dose1

Arm Type

Experimental

Arm Description

SHR4640 dose1 once a day, orally, for 36 weeks

Arm Title

SHR4640 dose2

Arm Type

Experimental

Arm Description

SHR4640 dose2 once a day, orally, for 36 weeks

Arm Title

Allopurinol

Arm Type

Active Comparator

Arm Description

Allopurinol 300mg (milligram) once a day, Orally, for 36 week

Intervention Type

Drug

Intervention Name(s)

SHR4640 dose1

Intervention Description

tablets，dose1，QD

Intervention Type

Drug

Intervention Name(s)

SHR4640 dose2

Intervention Description

tablets，dose2，QD

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

tablets，QD

Intervention Type

Drug

Intervention Name(s)

Allopurinol 300 MG

Intervention Description

tablets，300mg，QD

Primary Outcome Measure Information:

Title

Proportion of subjects with a serum uric level≤360μmol/l.

Description

Proportion of subjects with a serum uric level≤360μmol/l.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Week 36

Title

Percentage change from baseline in serum uric level

Description

Percentage change from baseline in serum uric level

Time Frame

Up to 36 weeks

Title

Actual change from baseline in serum uric level

Description

Actual change from baseline in serum uric level

Time Frame

Up to 36 weeks

Title

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

Description

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

Time Frame

Up to 36 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; 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 allopurinal, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunde Bao

Organizational Affiliation

Shanghai Jiaotong University School of Medicine,Renji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

RenJi Hospital Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout

We'll reach out to this number within 24 hrs