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

Status: Recruiting
Location: See all (26) 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 hyperuricemia associated with 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 (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) 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.

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
Healthcare Research Network - Tinley Park
RECRUITING
Flossmoor
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
Healthcare Research Network
RECRUITING
Hazelwood
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
RECRUITING
Mason
Oklahoma
DelRicht Research - Tulsa
RECRUITING
Tulsa
Tennessee
DelRicht Research - Hendersonville
RECRUITING
Hendersonville
Texas
Zenos Clinical Research
RECRUITING
Dallas
Pioneer Research Solutions
RECRUITING
Houston
Alliance Clinical Lewisville (Epic Clinical Research)
RECRUITING
Lewisville
Discovery Clinical Trials
RECRUITING
San Antonio
Contact Information
Primary
Clinical Trial Lead
ClinicalTrials@crystalystx.com
(858) 356-4740
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-11-29
Participants
Target number of participants: 500
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 64.
Experimental: Dotinurad 2 mg Maintenance
Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4) and then dotinurad 2 mg QD through Week 64.
Experimental: Dotinurad 4 mg Maintenance
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 through Week 64.
Related Therapeutic Areas
Sponsors
Leads: Crystalys Therapeutics

This content was sourced from clinicaltrials.gov

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