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 (63) 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
Alabama
Alabama Clinical Therapeutics
RECRUITING
Birmingham
Arizona
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
RECRUITING
Gilbert
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
RECRUITING
Glendale
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
RECRUITING
Mesa
Del Sol Research Management - Tucson East
RECRUITING
Tucson
California
Medvin Clinical Research - Covina
RECRUITING
Covina
West Coast Research
RECRUITING
Dublin
Infinity Clinical Research
RECRUITING
Norco
Amicis Research Center - Balboa
RECRUITING
Northridge
Dream Team Clinical Research
RECRUITING
Pomona
Acclaim Clinical Research, Inc.
RECRUITING
San Diego
East Bay Rheumatology Medical Group
RECRUITING
San Leandro
BTC Network - Encompass Clinical Research
RECRUITING
Spring Valley
Cohen Medical Centers
RECRUITING
Thousand Oaks
Medvin Clinical Research - Tujunga
RECRUITING
Tujunga
Colorado
Denver Arthritis Clinic - Lowry
RECRUITING
Denver
Florida
Bradenton Research Center
RECRUITING
Bradenton
Herco Medical and Research Center, Inc
RECRUITING
Coral Gables
Best Quality Research
RECRUITING
Hialeah
New Generation of Medical Research
RECRUITING
Hialeah
Health Awareness Inc
RECRUITING
Jupiter
Clinical Research of Center Florida
RECRUITING
Lakeland
D&H Pompano Research Center
RECRUITING
Margate
Anchor Medical Research, LLC
RECRUITING
Miami
Panax Clinical Research
RECRUITING
Miami Lakes
Omega Research DeBary
RECRUITING
Orlando
Clinical Research Trials of Florida
RECRUITING
Tampa
Georgia
DelRicht Research - Atlanta
RECRUITING
Atlanta
Illinois
Chicago Clinical Research Institute, Inc. (CCRII)
RECRUITING
Chicago
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
RECRUITING
Chicago
Indiana
MediSphere Medical Research Center, LLC - East
RECRUITING
Evansville
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
Tandem Clinical Research - Metairie Clinic
RECRUITING
Metairie
DelRicht Research - LCMC Health Urgent Care - Lakeview
RECRUITING
New Orleans
DelRicht Research - Prairieville
RECRUITING
Prairieville
Massachusetts
MedVadis Research
RECRUITING
Waltham
Maryland
MD Medical Research - Oxon Hill
RECRUITING
Oxon Hill
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
RECRUITING
Rockville
Michigan
DM Clinical Research - Detroit
RECRUITING
Southfield
Oakland Medical Center
RECRUITING
Troy
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
Nevada
Las Vegas Clinical Trials
RECRUITING
North Las Vegas
New York
Ellipsis Research Group
RECRUITING
Brooklyn
Ohio
Hometown Urgent Care and Research - Dayton
RECRUITING
Dayton
Delricht Research - Concierge Medicine Of Cincinnati
RECRUITING
Mason
Oklahoma
DelRicht Research - Tulsa
RECRUITING
Tulsa
Pennsylvania
Suburban Research Associates - West Chester Office
RECRUITING
West Chester
South Carolina
Coastal Carolina Research Center - Main
RECRUITING
North Charleston
South Dakota
Health Concepts
RECRUITING
Rapid City
Tennessee
DelRicht Research - Hendersonville
RECRUITING
Hendersonville
Texas
Zenos Clinical Research
RECRUITING
Dallas
Lone Star Arthritis & Rheumatology Associates - Denton
RECRUITING
Denton
Epic Medical Research - DeSoto
RECRUITING
Desoto
Pioneeer Research Solutions
RECRUITING
Houston
Alliance Clinical Lewisville (Epic Clinical Research)
RECRUITING
Lewisville
Discovery Clinical Trials
RECRUITING
San Antonio
DM Clinical Research - Tomball - Multiple Specialties
RECRUITING
Tomball
Virginia
Charlottesville Medical Research
RECRUITING
Charlottesville
Contact Information
Primary
Clinical Trial Lead
ClinicalTrials@crystalystx.com
(858) 356-4740
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 250
Treatments
Active_comparator: Allopurinol
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.
Related Therapeutic Areas
Sponsors
Leads: Crystalys Therapeutics

This content was sourced from clinicaltrials.gov