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

NCT05007392 | Completed Phase 3 Results

• 1 other identifier: FYU-981-J086-301
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Gout

Keywords

Dotinurad; Febuxostat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)

  At Week 12

• Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24

  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

  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

  Baseline, Weeks 4, 8, 12, 16, 20 and 24

• Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24

  Baseline, Weeks 4, 8, 12, 16, 20 and 24

Study Arms (2)

Drug: Dotinurad + Febuxostat Matched Placebo

EXPERIMENTAL

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; Other: Febuxostat Matched Placebo

Drug: Febuxostat + Dotinurad Matched Placebo

ACTIVE COMPARATOR

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; Other: Dotinurad Matched Placebo

Interventions

Dotinurad DRUG

Dotinurad oral tablets.

Also known as: FYU-981

Drug: Dotinurad + Febuxostat Matched Placebo

Febuxostat DRUG

Febuxostat oral tablets.

Drug: Febuxostat + Dotinurad Matched Placebo

Dotinurad Matched Placebo OTHER

Dotinurad matched placebo oral tablets.

Drug: Febuxostat + Dotinurad Matched Placebo

Febuxostat Matched Placebo OTHER

Febuxostat matched placebo oral tablets.

Drug: Dotinurad + Febuxostat Matched Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Male or female participant with age greater than or equal to (\>=) 18 years at the time of informed consent
• 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

You may not qualify if:

• Has gouty arthritis that has not resolved within 14 days prior to randomization
• Has secondary hyperuricemia
• Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)
• 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
• 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
• Estimated glomerular filtration rate (eGFR) of less than (\<) 30 milliliter per minute/1.73 square meters in the screening phase
• Systolic blood pressure of \>=180 millimetre of mercury (mmHg) or diastolic blood pressure of \>=110 mmHg in the screening phase
• Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of \>=8.4 percent (%) in the screening phase
• Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (30)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China

Beijing, Beijing Municipality, 101100, China

Location

Foshan First People's Hospital

Foshan, Guangdong, 528000, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Jieyang People's Hospital

Jieyang, Guangdong, China

Location

The Seventh Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, 200090, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hu'nan, 410013, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

First Affiliated Hospital of Inner Mongolia technological University

Baotou, Inner Mongolia, 14010, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 10050, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 210300, China

Location

Nanjing Medical University Affiliated 2nd Hospital

Nanjing, Jiangsu, 210011, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, Jiangxi, 337055, China

Location

Jilin Province People's Hospital

Changchun, Jilin, 130021, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Yanbian University Hospital

Yanji, Jilin, 133000, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, 116021, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200050, China

Location

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, 200052, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yun'nan, 650032, China

Location

MeSH Terms

Conditions

Gout

Interventions

dotinurad; Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eisai Inquiry Service
• Organization: Eisai Co., Ltd.

eisai-chiken_hotline@hhc.eisai.co.jp

none

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 16, 2021
• Study Start: December 21, 2021
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (30)