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

Sponsor
Eisai Co., Ltd.
Study ID
NCT05007392
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dotinurad — DRUG
    Dotinurad oral tablets.
  • Febuxostat — DRUG
    Febuxostat oral tablets.
  • Dotinurad Matched Placebo — OTHER
    Dotinurad matched placebo oral tablets.
  • Febuxostat Matched Placebo — OTHER
    Febuxostat matched placebo oral tablets.

Study Details

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.

Key Dates

Start date
Dec 21, 2021
Status verified
Jul 2025
Primary completion
Jun 14, 2023
Completion
Jun 14, 2023

Study Design

Enrollment
451 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).

Primary Outcome Measure

Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) [ Time Frame: At Week 24 ]

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