A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia

CompletadoFase 3ClinicalTrials.gov

ID: NCT05586971Tipo: INTERVENTIONALInicio: 30 de mar de 2023Fin estimado: 6 de may de 2025

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Resumen

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Male or female subjects between the ages of 18 85 years, inclusive.
Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).

Criterios de exclusión

Subjects with secondary hyperuricemia and enzymatic defects.
Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).

Intervenciones

drug

Tigulixostat

Xanthine Oxidase Inhibitor

drug

Allopurinol

Xanthine Oxidase Inhibitor

drug

Placebo

Matching placebo

Ubicaciones

Hospital Universitario Austral

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas San Nicolás

Buenos Aires, Argentina

Centro Médico Reumatologico - Organizacion Medica de Investigacion S.A. (OMI)

Buenos Aires, Argentina

Aprillus Asistencia e Investigacion Clinica

Buenos Aires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Argentina

Clinica Adventista Belgrano

Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Cordoba

Córdoba, Argentina

Centro Integral De Dianogostico por Imagenes Marchegiani (CIDIM)

Córdoba, Argentina

Instituto Reumatologico Strusberg

Córdoba, Argentina

Clinica Privada Velez Sarsfield (CPVS)

Córdoba, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Argentina

Instituto CAICI (Instituto Centralizado de Asistencia e Investigacion Clinica Integral)

Santa Fe, Argentina

Patrocinadores

PrincipalLG Chem

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