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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04956432
Collaborator
(none)
288
1
2
13.5
21.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with goutTo evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
Actual Study Start Date :
Jun 15, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A

SHR4640+Allopurinol Placebo;once a day, orally, for 16 weeks

Drug: SHR4640
SHR4640 Dose 1 ,tablets, QD

Active Comparator: Treatment group B

Allopurinol+ SHR4640 Placebo;once a day, orally, for 16 weeks.

Drug: Allopurinol
Allopurinol 300mg, tablets, QD

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with a serum uric acid level≤360 μmol/L [Start of Treatment to end of study (approximately 16 weeks)]

Secondary Outcome Measures

  1. 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)]

  2. 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)]

  3. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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:
  1. Subject who is pregnant or breastfeeding;

  2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;

  3. Subject with a positive test for HLA-B*5801;

  4. Estimated glomerular filtration rate (MDRD formula) <60ml/min;

  5. HbA1c≥8%;

  6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640;

  7. Subject with kidney stones or suspicion of kidney stones;

  8. Subject who has acute gout flares within 2 weeks before randomization;

  9. Subject with a history of malignancy within the previous 5 years;

  10. Subject with a history of active peptic ulcer within a year;

  11. Subject with a history of xanthine urine.

Contacts and Locations

Locations

Site City State Country Postal Code
1 RenJi Hospital, Shanghai JiaoTong University School Of Medicine Shanghai Shanghai China 200127

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04956432
Other Study ID Numbers:
  • SHR4640-303
First Posted:
Jul 9, 2021
Last Update Posted:
Jul 9, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2021