DOTINURAD for Gout | Hyperuricemia

Inclusion criteria

• {"criterion_text":"- 1. Provide written informed consent and any authorizations required by local law.\n- 2. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.\n- 3. Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.\n- 4. Had at least 2 gout flares in the 12 months prior to Screening\n- 5. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening.\n- 6. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).\n- 7. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n- 8. 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 study drug."}

Exclusion criteria

• {"criterion_text":"- 1. History of or presence of kidney stones within 1 year prior to Screening.\n- 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.\n- 3. Hypersensitivity or intolerance to dotinurad or to colchicine AND NSAIDs.\n- 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse\n- 5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.\n- 6. Participants with unstable long-term conditions, such as diabetes, high cholesterol, hypertension, asthma, etc.\n- 7. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results."}

Primary endpoints

• {"endpoint_text":"- 1. Proportion of participants with an sUA level <6.0 mg/dL at Week 24.","definition_or_measurement_approach":"Serum uric acid (sUA) measurement at Week 24; endpoint is proportion of participants with sUA <6.0 mg/dL at Week 24."}

Secondary endpoints

• {"endpoint_text":"- 1. Proportion of participants with an sUA level <6.0 mg/dL at Weeks 16, 20, and 24, inclusive.","definition_or_measurement_approach":"Serum uric acid (sUA) measurements at Weeks 16, 20 and 24; endpoint is proportion with sUA <6.0 mg/dL at those visits."}
• {"endpoint_text":"- 2. Mean rate of gout flares requiring treatment from Week 36 through Week 64.","definition_or_measurement_approach":"Count of gout flares requiring treatment captured from Week 36 through Week 64; reported as mean rate over that interval."}
• {"endpoint_text":"- 3. Proportion of participants with an sUA level <5.0 mg/dL at Week 24 AND no gout flares requiring treatment from Week 36 through Week 64.","definition_or_measurement_approach":"Composite endpoint requiring sUA <5.0 mg/dL at Week 24 and absence of gout flares requiring treatment during Weeks 36–64."}

Methods

• Website recruitment / Participant Digital Outreach (digital) — localized materials available (Spanish and Polish).
• Facebook ads (digital) — participant-targeted recruitment materials (Spanish and Polish versions listed).
• Radio ads (audio) — Spanish version indicated.
• Print advertising and brochures — patient brochures, posters and print ads (Spanish and Polish materials listed).
• HCP engagement (Dear Colleague letters, HCP factsheets) — clinician-targeted recruitment materials to referring physicians/sites.
• Direct patient contact (Dear Patient letters, Participant brochures, ICF Flipbook) — clinic-based recruitment materials for patients.
• Site-based recruitment through participating hospitals/clinics and clinical research organisations.

Spain

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

24-03-2026

Processing Time Days

239

Number Of Sites

7

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

22-02-2026

Processing Time Days

142

Number Of Sites

13

Number Of Participants

50

Primary sponsor

Full Name

Crystalys Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Multiple trial management and operational responsibilities (regulatory, central laboratory coordination, data management, monitoring and other roles listed in sponsorDuties).

Name

QPS LLC

Responsibilities

Clinical services (code 4).

Name

Almac Clinical Services Limited

Responsibilities

QP release and associated clinical supply services.

Name

Medidata Solutions Inc.

Responsibilities

Clinical trial technology/platform services.

Name

Clario Medical Imaging Inc.

Responsibilities

Electronic Clinical Outcome Assessment (eCOA).

Name

AG Mednet Inc.

Responsibilities

Electronic adjudication system.

Third parties

• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel and reimburesment services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"Electronic Clinical Outcome Assessment (eCOA)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"AG Mednet Inc.","duties_or_roles":"Electronic Adjudication System","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Clinical trial technology/platform services (document code 7 listed)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"QP release","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Clinical services (duty code 4)","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Certe Medische Diagnostiek en Advies Stichting","duties_or_roles":"Central laboratory / laboratory services (duty code 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple trial management and operational roles including regulatory submissions and centralised trial functions (many duties codes listed: e.g. 1,2,3,4,5,6,8,10,11,12,13,15 etc.)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Cyberchrome Inc.","duties_or_roles":"Materials for patient recruitment services","organisation_type":"Non-Pharmaceutical company"}