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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent. 2. 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). 3. sUA level >6.0 and <10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit). 4. 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. 5. 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.

Exclusion Criteria

  1. History of or presence of kidney stones within 1 year prior to Screening. 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma. 3. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse. 4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening. 5. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: Dotinurad
    Over-encapsulated tablets containing active drug substance administered orally.
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).
  • Drug: Dotinurad
    Over-encapsulated tablets containing active drug substance administered orally.
  • Other: Placebo
    Capsules containing microcrystalline cellulose administered orally.

Recruiting Locations

Amicis Research Center
Granada Hills, California 91344
Contact:
Pascal Dabel, MD

Cohen Medical Center
Thousand Oaks, California 91360
Contact:
Shariar Cohen-Gadol, MD

Solace Clinical Research
Tustin, California 92780
Contact:
Roger Kornu, MD

Denver Arthritis Clinic - Lowry
Denver, Colorado 80230
Contact:
Christopher Antolini, MD

Omega Research Group
DeBary, Florida 32713
Contact:
Kwabena Ayesu, MD

Herco Medical and Research Center, Inc
Flagami, Florida 33126
Contact:
Eddy Capote, MD

New Generation of Medical Research
Hialeah, Florida 33016
Contact:
Karelia Ruiz, MD

Health Awareness, Inc.
Jupiter, Florida 33458
Contact:
Ronald Surowitz, MD

Clinical Research of Central Florida
Lakeland, Florida 33805
Contact:
Michael Gimness, MD

D&H Pompano Research Center, LLC
Margate, Florida 33063
Contact:
Mazyar Rouhani, MD

Panax Clinical Research
Miami, Florida 33014
Contact:
Robert Perry, MD

Anchor Medical Research
Miami, Florida 33176
Contact:
Juvenal Martinez, MD

MD Medical Research
Oxon Hill, Maryland 20745
Contact:
Stephen Ong, MD

Clinical Research Institute of Michigan
Saint Clair Shores, Michigan 48081
Contact:
Amar Majjhoo, MD

Revival Research Institute
Sterling Heights, Michigan 48313
Contact:
Syed Husain, MD

Las Vegas Clinical Trials
Las Vegas, Nevada 89030
Contact:
Alton Walters, MD

Premier Health Research
Sparta, New Jersey 07871
Contact:
Haroon Sarwar, MD

Ellipsis Research Group
Brooklyn, New York 11215
Contact:
Jorge Serje, MD

Drug Trials America
Hartsdale, New York 10530
Contact:
Michael Gerdis, MD

Shelby Clinical Research
Shelby, North Carolina 28150
Contact:
Christian Martin, MD

Hometown Urgent Care and Research
Dayton, Ohio 45424
Contact:
Carol Bland, MD

Zenos Clinical Research
Dallas, Texas 75230
Contact:
Bachar Elsaadi, MD

Epic Medical Research
DeSoto, Texas 75115
Contact:
Haresh Boghara, MD

Pioneer Research Solutions
Houston, Texas 77479
Contact:
Francisco Velazquez, MD

R&H Clinical Research - Westborough Drive
Katy, Texas 77449
Contact:
Maryam Khawari, MD

Southwest Rheumatology Research
Mesquite, Texas 75150
Contact:
Atul Singhal, MD

Discovery Clinical Trials, LLC
San Antonio, Texas 78229
Contact:
Abha Gyani, MD

DM Clinical Research
Tomball, Texas 77375
Contact:
Shaikh Ali, MD

Digestive Health Research of North Texas
Wichita Falls, Texas 76301
Contact:
Vanya Wagler, MD

More Details

Status
Recruiting
Sponsor
Crystalys Therapeutics

Study Contact

Clinical Trial Lead
1-858-379-2316
ClinicalTrials@crystalystx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.