A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
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 (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:
‣ History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.
⁃ Failed uricase treatment (eg, an sUA level \>6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).
• sUA level \>6.0 and \<10.5 mg/dL at both Screening Visit 1 (Day -28 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 -28 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 trial drug.
Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
RECRUITING
Birmingham
California
Amicis Research Center
RECRUITING
Granada Hills
Cohen Medical Center
RECRUITING
Thousand Oaks
Solace Clinical Research
RECRUITING
Tustin
Colorado
Denver Arthritis Clinic - Lowry
RECRUITING
Denver
Florida
Omega Research Group
RECRUITING
Debary
Herco Medical and Research Center, Inc
RECRUITING
Flagami
New Generation of Medical Research
RECRUITING
Hialeah
Health Awareness, Inc.
RECRUITING
Jupiter
Clinical Research of Central Florida
RECRUITING
Lakeland
D&H Pompano Research Center, LLC
RECRUITING
Margate
Anchor Medical Research
RECRUITING
Miami
Panax Clinical Research
RECRUITING
Miami
Georgia
Southwest Atlanta Internal Medicine
RECRUITING
Atlanta
Illinois
Great Lakes Clinical Trials
RECRUITING
Chicago
Kentucky
Research Group of Lexington, LLC
RECRUITING
Lexington
Maryland
MD Medical Research
RECRUITING
Oxon Hill
Michigan
Clinical Research Institute of Michigan
RECRUITING
Saint Clair Shores
Revival Research Institute
RECRUITING
Sterling Heights
Oakland Medical Research Center
RECRUITING
Troy
North Carolina
DJL Clinical Research
RECRUITING
Charlotte
Shelby Clinical Research
RECRUITING
Shelby
Nebraska
Velocity Clinical Research
RECRUITING
Norfolk
New Jersey
Premier Health Research
RECRUITING
Sparta
Nevada
Las Vegas Clinical Trials
RECRUITING
Las Vegas
New York
Ellipsis Research Group
RECRUITING
Brooklyn
Drug Trials America
RECRUITING
Hartsdale
Ohio
Hometown Urgent Care and Research
RECRUITING
Dayton
Texas
Amarillo Premier Research
RECRUITING
Amarillo
Zenos Clinical Research
RECRUITING
Dallas
Epic Medical Research
RECRUITING
Desoto
Pioneer Research Solutions
RECRUITING
Houston
R&H Clinical Research - Westborough Drive
RECRUITING
Katy
Southwest Rheumatology Research
RECRUITING
Mesquite
Discovery Clinical Trials, LLC
RECRUITING
San Antonio
DM Clinical Research
RECRUITING
Tomball
Velocity Clinical Research (Impact Research Institute)
RECRUITING
Waco
Digestive Health Research of North Texas
RECRUITING
Wichita Falls
Contact Information
Primary
Clinical Trial Lead
ClinicalTrials@crystalystx.com
1-858-379-2316
Time Frame
Start Date:2026-05-08
Estimated Completion Date:2027-08
Participants
Target number of participants:90
Treatments
Experimental: Dotinurad
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).
Experimental: Placebo + Placebo to Dotinuard
The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).