A Study of Dotinurad Versus Allopurinol in Participants With Gout
Phase 3 – large-scale trial before approval
Conditions:
Gout
Sponsor: Crystalys Therapeutics
trial.available_in:
БГ
Overview
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
Who can participate
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.
3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
4. 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 and remain on their dosing regimen until Day 1.
5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
6. 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.
7. 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:
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. Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs.
4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
6. 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.
Interventions
Allopurinol
DRUG
Dotinurad
DRUG
Locations
95
Poland (12)
ClinicMed Daniluk, Nowak Spółka Komandytowa
Bialystok , Podlaskie Voivodeship
FutureMeds Gdynia
Gdynia , Pomeranian Voivodeship
Pro Familia - Katowice
Katowice , Silesian Voivodeship
Silmedic sp. z o.o.
Katowice , Silesian Voivodeship
FutureMeds - Krakow
Krakow , Lesser Poland Voivodeship
Innova Clinic
Plońsk , Masovian Voivodeship
Centrum Medyczne Solumed
Poznan , Greater Poland Voivodeship
Prolato Clinical Research Center
Sochaczew , Masovian Voivodeship
Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna
Warsaw , Masovian Voivodeship
FutureMeds - Targówek
Warsaw , Masovian Voivodeship
Med-Progress Ośrodek Nowoczesnego Leczenia
Wejherowo , Pomeranian Voivodeship
FutureMeds - Wroclaw
Wroclaw , Lower Silesian Voivodeship
Spain (7)
Complejo Hospitalario Universitario A Coruña
A Coruña , La Coruña
Accellacare - Alcobendas
Alcobendas , Madrid
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Infanta Leonor
Madrid , Madrid
Clínica Gaias Santiago
Santiago de Compostela , La Coruña
Hospital Quirónsalud Infanta Luisa
Seville , Sevilla
Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología
Seville , Sevilla
United States (76)
DelRicht Research - Atlanta
Atlanta , Georgia
WITHDRAWN
University of Alabama at Birmingham
Birmingham , Alabama
Alabama Clinical Therapeutics
Birmingham , Alabama
WITHDRAWN
Bradenton Research Center
Bradenton , Florida
Ellipsis Research Group
Brooklyn , New York
Investigators Research Group
Brownsburg , Indiana
DelRicht Research - Charlotte (Direct Primary Care - DPC)
БГ