The trial is taking place at:
F

Family Care Research | Boise, ID

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

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Status and phase

Enrolling
Phase 3

Conditions

Hyperuricemia
Tophi
Gout Flare
Gout

Treatments

Drug: Tigulixostat
Drug: Placebo
Drug: Allopurinol

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

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

Trial contacts and locations

124

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Central trial contact

Younghwan Jang

Data sourced from clinicaltrials.gov

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