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EURELIA1: Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Sponsor
LG Chem (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05586958
Collaborator
(none)
350
Enrollment
1
Location
4
Arms
31.2
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia
Actual Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tigulixostat 100mg

Tigulixostat 100mg, Once a day (QD) for up to 6 months

Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
  • LC350189

    		•
    Experimental: Tigulixostat 200mg

    Tigulixostat 200mg, Once a day (QD) for up to 6 months

    Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other Names:
  • LC350189

    		•
    Experimental: Tigulixostat 300mg

    Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months

    Drug: Tigulixostat
    Xanthine Oxidase Inhibitor
    Other Names:
  • LC350189

    		•
    Placebo Comparator: Placebo

    Placebo, Once a day (QD) for up to 6 months

    Drug: Placebo
    Matching placebo

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 [Up to Month 6]

      Serum uric acid (sUA) level will be measured at Month 4,5, and 6

    Secondary Outcome Measures

    1. The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 [Up to Month 6]

      Serum uric acid (sUA) level will be measured at Month 4,5, and 6

    2. The proportion of subjects reporting a gout flare up to each visit. [Up to Month 6]

      Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months

    3. Incidence rate of adverse event [Up to Month 6]

      Safety assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    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, 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) and rheumatoid arthritis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pioneer Research Solutions, Inc. Houston Texas United States 77099

    Sponsors and Collaborators

    • LG Chem

    Investigators

    • Study Director: Jisoo Lee, MD, LG Chem

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LG Chem
    ClinicalTrials.gov Identifier:
    NCT05586958
    Other Study ID Numbers:
    • LG-GDCL009
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Jan 11, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by LG Chem
    Gout
    Hyperuricemia
    Xanthine Oxidase Inhibitor
    Additional relevant MeSH terms:
    Gout
    Hyperuricemia

    Study Results

    No Results Posted as of Jan 11, 2023