A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout

The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Dotinurad; Other: Febuxostat Matched Placebo; Drug: Febuxostat; Other: Dotinurad Matched Placebo

• Study Type: Interventional
• Enrollment (Actual): 451
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100029
      • Beijing Anzhen Hospital，Capital Medical University
    • Beijing, Beijing, China, 100034
      • Beijing Hospital
    • Beijing, Beijing, China, 101100
      • Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Foshan First People's Hospital
    • Guangzhou, Guangdong, China, 510280
      • ZhuJiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510080
      • Guangzhou First People's Hospital
    • Jieyang, Guangdong, China
      • Jieyang People's Hospital
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen People's Hospital
    • Shenzhen, Guangdong, China, 200090
      • The Seventh Affiliated Hospital of Sun Yat-sen University
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 14010
      • First Affiliated Hospital of Inner Mongolia technological University
    • Hohhot, Inner Mongolia, China, 10050
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 210300
      • The First People's Hospital of Changzhou
    • Nanjing, Jiangsu, China, 210011
      • Nanjing Medical University Affiliated 2nd Hospital
    • Yangzhou, Jiangsu, China, 225000
      • Northern Jiangsu People's Hospital
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
    • Yanji, Jilin, China, 133000
      • Yanbian University Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116023
      • The Second Hospital of Dalian Medical University
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University
    • Dalian, Liaoning, China, 116021
      • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • Shandong
    • Qingdao, Shandong, China, 266000
      • The Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200050
      • Tong Ren Hospital Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200052
      • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First People's Hospital of Yunnan Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization)
2. Male or female participant with age greater than or equal to (>=) 18 years at the time of informed consent
3. Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

1. Has gouty arthritis that has not resolved within 14 days prior to randomization
2. Has secondary hyperuricemia
3. Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)
4. Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
5. Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in the screening phase
6. Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter per minute/1.73 square meters in the screening phase
7. Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic blood pressure of >=110 mmHg in the screening phase
8. Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4 percent (%) in the screening phase
9. Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Dotinurad + Febuxostat Matched Placebo; Participants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).	Drug: Dotinurad; Dotinurad oral tablets.; Other Names: FYU-981; Other: Febuxostat Matched Placebo; Febuxostat matched placebo oral tablets.
Active Comparator: Drug: Febuxostat + Dotinurad Matched Placebo; Participants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).	Drug: Febuxostat; Febuxostat oral tablets.; Other: Dotinurad Matched Placebo; Dotinurad matched placebo oral tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)	Percentage of participants with SUA level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)	Percentage of participants with SUA level <=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.	At Week 12
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24	Percentage of participants with SUA level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.	At Weeks 4, 8, 12, 16, 20 and 24
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24	Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.	Baseline, Weeks 4, 8, 12, 16, 20 and 24
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24	Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.	Baseline, Weeks 4, 8, 12, 16, 20 and 24
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24	Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.	Baseline, Weeks 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Febuxostat; Dotinurad
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Gout Suppressants; Antirheumatic Agents; Uricosuric Agents; Febuxostat; Dotinurad
• Other Study ID Numbers: FYU-981-J086-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No