Gout

Last updated: July 6, 2023
Sponsor: LG Chem
Overall Status: Active - Recruiting

Phase

3

Condition

Gout (Hyperuricemia)

Treatment

N/A

Clinical Study ID

TX310395
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-85

  • Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.

  • Subjects with a Body Mass Index ≤50 kg/m2.

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 (Hyperuricemia)

  • Clinical Trial Identifier: NCT05586971

  • Sponsor: LG Chem

  • Looking for participates within a 30-mile radius of the study location.

Connect with a study center

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Clinical Physiology Associates

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

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