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RECRUITINGPhase 3INTERVENTIONAL

A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 tophaceous gout.

Who May Be Eligible (Plain English)

Inclusion Criteria 1. Between 18 and 75 years of age (inclusive) at the time of signing willing to sign a consent form. 2. Diagnosis of gout based on 2015 American College of Rheumatology-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year. 3. Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter. 4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit). 5. 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. 6. 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 willing to sign a consent form through 30 days after the last dose of study drug. Exclusion Criteria 1. History of or presence of kidney stones within 1 year prior to Screening. 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma. 3. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs). 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 5. Known history of or positive results for human weakened immune system virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria 1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent. 2. Diagnosis of gout based on 2015 American College of Rheumatology-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year. 3. Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter. 4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit). 5. 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. 6. 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 1. History of or presence of kidney stones within 1 year prior to Screening. 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma. 3. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs). 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.

Treatments Being Tested

DRUG

Allopurinol

Over-encapsulated tablets containing active drug substance administered orally (PO).

DRUG

Dotinurad

Over-encapsulated tablets containing active drug substance administered PO.

Locations (20)

Alabama Clinical Therapeutics
Birmingham, Alabama, United States
G & L Research
Foley, Alabama, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States
Del Sol Research Management - Tucson East
Tucson, Arizona, United States
Medvin Clinical Research - Covina
Covina, California, United States
West Coast Research
Dublin, California, United States
Infinity Clinical Research
Norco, California, United States
Amicis Research Center - Balboa
Northridge, California, United States
Dream Team Clinical Research
Pomona, California, United States
Acclaim Clinical Research, Inc.
San Diego, California, United States
East Bay Rheumatology Medical Group
San Leandro, California, United States
BTC Network - Encompass Clinical Research
Spring Valley, California, United States
Cohen Medical Centers
Thousand Oaks, California, United States
Medvin Clinical Research - Tujunga
Tujunga, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Bradenton Research Center
Bradenton, Florida, United States
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States