RecruitingPhase 2NCT07535034

A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

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

Sponsor

Crystalys Therapeutics

Enrollment

90 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Gout

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dotinurad and Placebo for people with gout. The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDotinurad

Over-encapsulated tablets containing active drug substance administered orally.

OTHERPlacebo

Capsules containing microcrystalline cellulose administered orally.

Locations(38)

The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, United States

Amicis Research Center

Granada Hills, California, United States

Cohen Medical Center

Thousand Oaks, California, United States

Solace Clinical Research

Tustin, California, United States

Denver Arthritis Clinic - Lowry

Denver, Colorado, United States

Omega Research Group

DeBary, Florida, United States

Herco Medical and Research Center, Inc

Flagami, Florida, United States

New Generation of Medical Research

Hialeah, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Clinical Research of Central Florida

Lakeland, Florida, United States

D&H Pompano Research Center, LLC

Margate, Florida, United States

Panax Clinical Research

Miami, Florida, United States

Anchor Medical Research

Miami, Florida, United States

Southwest Atlanta Internal Medicine

Atlanta, Georgia, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Research Group of Lexington, LLC

Lexington, Kentucky, United States

MD Medical Research

Oxon Hill, Maryland, United States

Clinical Research Institute of Michigan

Saint Clair Shores, Michigan, United States

Revival Research Institute

Sterling Heights, Michigan, United States

Oakland Medical Research Center

Troy, Michigan, United States

Velocity Clinical Research

Norfolk, Nebraska, United States

Las Vegas Clinical Trials

Las Vegas, Nevada, United States

Premier Health Research

Sparta, New Jersey, United States

Ellipsis Research Group

Brooklyn, New York, United States

Drug Trials America

Hartsdale, New York, United States

DJL Clinical Research

Charlotte, North Carolina, United States

Shelby Clinical Research

Shelby, North Carolina, United States

Hometown Urgent Care and Research

Dayton, Ohio, United States

Amarillo Premier Research

Amarillo, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Epic Medical Research

DeSoto, Texas, United States

Pioneer Research Solutions

Houston, Texas, United States

R&H Clinical Research - Westborough Drive

Katy, Texas, United States

Southwest Rheumatology Research

Mesquite, Texas, United States

Discovery Clinical Trials, LLC

San Antonio, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Velocity Clinical Research (Impact Research Institute)

Waco, Texas, United States

Digestive Health Research of North Texas

Wichita Falls, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07535034

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