Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

Purpose

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.

Conditions

  • Gout
  • Hyperuricemia
  • Gout Flare
  • Tophi

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tigulixostat 100mg 		Tigulixostat 100mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Experimental
Tigulixostat 200mg 		Tigulixostat 200mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Experimental
Tigulixostat 300mg 		Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other names:
    • LC350189
Active Comparator
Titrated allopurinol (100-800mg) 		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.
  • Drug: Allopurinol
    Xanthine Oxidase Inhibitor
Placebo Comparator
Placebo 		Placebo, three times a day (TID) for up to 6 months.
  • Drug: Placebo
    Matching placebo

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35249

More Details

Status
Recruiting
Sponsor
LG Chem

Study Contact

Younghwan Jang
+82-2-6987-4154
younghj@lgchem.com