A Study of Dotinurad Versus Allopurinol in Participants With Gout

Official title

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

Overview

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.

Interventions

• Drug Allopurinol
  Over-encapsulated tablets containing active drug substance administered orally (PO).
• Drug Dotinurad
  Over-encapsulated tablets containing active drug substance administered PO.

Primary outcome measures

• Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [Time frame: Week 24]

Secondary outcome measures (12)

• Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive [Time frame: Weeks 16, 20 and 24]
• Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64 [Time frame: Week 36 through Week 64]
• Percentage of Participants With an sUA level <5.0 mg/dL at Week 24 and no Gout Flares Requiring Treatment From Week 36 Through Week 64 [Time frame: Week 24 and Week 36 through Week 64]
• Mean Change From Baseline in sUA at Week 24 [Time frame: Baseline and Week 24]
• Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64 [Time frame: Week 24 through Week 64]
• Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit [Time frame: Up to Week 68]
• Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit [Time frame: Up to Week 68]
• Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit [Time frame: Up to Week 68]
• Absolute Change from Baseline in sUA Levels at Each Visit [Time frame: Baseline to Week 68]
• Percent Change from Baseline in sUA Levels at Each Visit [Time frame: Baseline to Week 68]
• Percentage of Participants With a Gout Flare Requiring Treatment at Each Visit Between Week 24 and the end of Study [Time frame: Week 24 to Week 68]
• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Day 1 through Week 68]

Eligibility criteria

Inclusion criteria

• Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
• Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
• Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
• Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.
• sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
• Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
• Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.

Exclusion criteria

• History of or presence of kidney stones within 1 year prior to Screening.
• History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
• Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.
• Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
• Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 83 centers

• University of Alabama at Birmingham — Birmingham
• Alabama Clinical Therapeutics — Birmingham
• Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert — Gilbert
• Arizona Arthritis & Rheumatology Associates (AARA) - Glendale — Glendale
• Arizona Arthritis & Rheumatology Associates (AARA) - Mesa — Mesa
• Del Sol Research Management - Tucson East — Tucson
• Del Sol Research Management - Tucson — Tucson
• Medvin Clinical Research - Covina — Covina
• … and 75 more centers

Poland · 13 centers

Center list to be confirmed — check the primary protocol.

Spain · 7 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07089875 · FYU-981-CRYS-301 · 2024-520206-19-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗