Clincosm LogoSign in Get a demo

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

Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05007392
Collaborator
(none)
450
Enrollment
30
Locations
2
Arms
21.3
Anticipated Duration (Months)
15
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
Actual Study Start Date :
Dec 21, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 [Week 24]

    Secondary Outcome Measures

    1. Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12 [Week 12]

    2. Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24 [Up to Week 24]

    3. Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24 [Baseline up to Week 24]

    4. Mean Change From Baseline in SUA Level in Participants up to Week 24 [Baseline up to Week 24]

    5. Mean SUA Level in Participants up to Week 24 [Up to Week 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Hospital Hefei Anhui China 230001
    2 Beijing Anzhen Hospital,Capital Medical University Beijing Beijing China 100029
    3 Beijing Hospital Beijing Beijing China 100034
    4 Peking University First Hospital Beijing Beijing China 100034
    5 Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China Beijing Beijing China 101100
    6 Foshan First People's Hospital Foshan Guangdong China 528000
    7 Guangzhou First People's Hospital Guangzhou Guangdong China 510080
    8 Zhujiang Hospital of Southern Medical University Guangzhou Guangdong China 510280
    9 Jieyang People's Hospital Jieyang Guangdong China
    10 The Seventh Affiliated Hospital of Sun Yat-sen University Shenzhen Guangdong China 200090
    11 Shenzhen People's Hospital Shenzhen Guangdong China 518020
    12 Hainan General Hospital Haikou Hainan China 570311
    13 Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Wuhan Hubei China 430030
    14 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
    15 First Affiliated Hospital of Inner Mongolia technological University Baotou Inner Mongolia China 14010
    16 The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia China 10050
    17 The First People's Hospital of Changzhou Changzhou Jiangsu China 210300
    18 Nanjing Medical University Affiliated 2nd Hospital Nanjing Jiangsu China 210011
    19 Northern Jiangsu People's Hospital Yangzhou Jiangsu China 225000
    20 Jiangxi Pingxiang People's Hospital Pingxiang Jiangxi China 337055
    21 Jilin Province People's Hospital Changchun Jilin China 130021
    22 The First Hospital of Jilin University Changchun Jilin China 130021
    23 Yanbian University Hospital Yanji Jilin China 133000
    24 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China 116011
    25 Dalian Municipal Central Hospital Affiliated of Dalian Medical University Dalian Liaoning China 116021
    26 The Second Hospital of Dalian Medical University Dalian Liaoning China 116023
    27 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266000
    28 Tong Ren Hospital Shanghai Jiaotong University School of Medicine Shanghai Shanghai China 200050
    29 Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine Shanghai Shanghai China 200052
    30 The First People's Hospital of Yunnan Province Kunming Yunnan China 650032

    Sponsors and Collaborators

    • Eisai Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05007392
    Other Study ID Numbers:
    • FYU-981-J086-301
    First Posted:
    Aug 16, 2021
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eisai Co., Ltd.
    Dotinurad
    Febuxostat
    Additional relevant MeSH terms:
    Gout
    Febuxostat
    Dotinurad

    Study Results

    No Results Posted as of Aug 9, 2022