Gout Treatment

Last updated: September 22, 2023
Sponsor: LG Chem
Overall Status: Active - Recruiting

Phase

3

Condition

Gout (Hyperuricemia)

Treatment

N/A

Clinical Study ID

TX318211
LG-GDCL010
  • Ages 18-85
  • All Genders

Study Summary

A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia

Eligibility Criteria

Inclusion

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

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

Study Start date:
Estimated Completion Date:

Study Description

  • Condition: Gout
  • Clinical Trial Identifier: NCT05586971
  • Sponsor: LG Chem

Connect with a study center

  • AMR Kansas City (formerly Center for Pharmaceutical Research)

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

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