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
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
• 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.
• sUA level ≥5.0 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.
Locations
United States
California
West Coast Research
RECRUITING
Dublin
Acclaim Clinical Research, Inc.
RECRUITING
San Diego
Florida
Herco Medical and Research Center, Inc
RECRUITING
Coral Gables
Best Quality Research
RECRUITING
Hialeah
Clinical Research Trials of Florida
RECRUITING
Tampa
Georgia
DelRicht Research - Atlanta
RECRUITING
Atlanta
Illinois
Chicago Clinical Research Institute, Inc. (CCRII)
RECRUITING
Chicago
Indiana
Delricht Research - Better Life Direct Primary Care
RECRUITING
Indianapolis
Kansas
Delricht Research - Concierge And Direct Primary Care
RECRUITING
Overland Park
Kentucky
DelRicht Research - Louisville (Derby City DPC)
RECRUITING
Louisville
Louisiana
DelRicht Research - LCMC Health Urgent Care - Lakeview
RECRUITING
New Orleans
DelRicht Research - Prairieville
RECRUITING
Prairieville
Maryland
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
RECRUITING
Rockville
Missouri
Delricht Research - Command Family Medicine
RECRUITING
Springfield
DelRicht Research - Town and Country
RECRUITING
Town And Country
North Carolina
DelRicht Research - Charlotte (Direct Primary Care - DPC)
RECRUITING
Charlotte
Shelby Clinical Research, LLC - North Carolina
RECRUITING
Shelby
Ohio
Delricht Research - Concierge Medicine Of Cincinnati
Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.
Experimental: Dotinurad
Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter up through Week 76.