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RECRUITING
NCT07535034
PHASE2

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

Sponsor: Crystalys Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-05-08

Completion Date

2027-08

Last Updated

2026-07-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dotinurad

Over-encapsulated tablets containing active drug substance administered orally.

OTHER

Placebo

Capsules containing microcrystalline cellulose administered orally.

Locations (29)

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

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

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

Shelby Clinical Research

Shelby, North Carolina, United States

Hometown Urgent Care and Research

Dayton, Ohio, 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

Digestive Health Research of North Texas

Wichita Falls, Texas, United States