Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients (EURELIA2)

LG Chem

Status and phase: Enrolling; Phase 3

Conditions: Hyperuricemia; Tophi; Gout Flare; Gout

Treatments: Drug: Allopurinol; Drug: Tigulixostat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05586971

LG-GDCL010

Details and patient eligibility

About

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.

Enrollment: 2,542 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 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,542 participants in 5 patient groups, including a placebo group

Tigulixostat 100mg

Experimental group

Description:

Tigulixostat 100mg, Once a day (QD) for up to 12 months

Treatment:

Drug: Tigulixostat

Tigulixostat 200mg

Experimental group

Description:

Tigulixostat 200mg, Once a day (QD) for up to 12 months

Treatment:

Drug: Tigulixostat

Tigulixostat 300mg

Experimental group

Description:

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months

Treatment:

Drug: Tigulixostat

Titrated allopurinol (100-800mg)

Active Comparator group

Description:

Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.

Treatment:

Drug: Allopurinol

Placebo

Placebo Comparator group

Description:

Placebo, three times a day (TID) for up to 6 months.

Treatment:

Drug: Placebo