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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

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

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

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

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

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

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

More Details

Status
Recruiting
Sponsor
Crystalys Therapeutics

Study Contact

Clinical Trial Lead
(858) 356-4740
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.