Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients (EURELIA1)

LG Chem

Status and phase: Enrolling; Phase 3

Conditions: Hyperuricemia; Gout Flare; Tophi; Gout

Treatments: Drug: Placebo; Drug: Tigulixostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05586958

LG-GDCL009

Details and patient eligibility

About

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• Subjects with secondary hyperuricemia, 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) and rheumatoid arthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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350 participants in 4 patient groups, including a placebo group

Tigulixostat 100mg

Experimental group

Description:

Tigulixostat 100mg, Once a day (QD) for up to 6 months

Treatment:

Drug: Tigulixostat

Tigulixostat 200mg

Experimental group

Description:

Tigulixostat 200mg, Once a day (QD) for up to 6 months

Treatment:

Drug: Tigulixostat

Tigulixostat 300mg

Experimental group

Description:

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months

Treatment:

Drug: Tigulixostat

Placebo

Placebo Comparator group

Description:

Placebo, Once a day (QD) for up to 6 months

Treatment:

Drug: Placebo