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

Crystalys Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Gout

Treatments: Drug: Dotinurad; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07535034

FYU-981-CRYS-201

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Dotinurad

Experimental group

Description:

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).

Treatment:

Drug: Dotinurad

Placebo + Placebo to Dotinuard

Experimental group

Description:

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).

Treatment:

Other: Placebo

Drug: Dotinurad