Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.