NCT04956432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
779

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

July 7, 2021

Last Update Submit

January 23, 2025

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (7)

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

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

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

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

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

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

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

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

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

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

  • +2 more secondary outcomes

Study Arms (2)

Treatment group A

EXPERIMENTAL

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

Drug: SHR4640

Treatment group B

ACTIVE COMPARATOR

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

Drug: Allopurinol

Interventions

SHR4640DRUG

SHR4640 Dose 1 ,tablets, QD

Treatment group A
AllopurinolDRUG

Allopurinol 300mg, tablets, QD

Treatment group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RenJi Hospital, Shanghai JiaoTong University School Of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Gout

Interventions

ruzinuradAllopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 9, 2021

Study Start

June 15, 2021

Primary Completion

December 13, 2023

Study Completion

August 23, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

CN(1)