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

ClinicalTrials.gov processed this data on August 24, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified August 2023 by LG Chem

Sponsor

LG Chem

Information Provided by (Responsible Party)

LG Chem

Clinicaltrials.gov Identifier

NCT05586958
Other Study ID Numbers: LG-GDCL009
First Submitted: October 16, 2022
First Posted: October 19, 2022
Last Update Posted: August 25, 2023
Last Verified: August 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Gout
  • Hyperuricemia
  • Gout Flare
  • Tophi
  • Drug: Tigulixostat
  • Drug: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment350 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateOctober 25, 2022
Anticipated Primary Completion DateDecember 2024
Anticipated Study Completion DateJune 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Tigulixostat 100mg
    • Tigulixostat 100mg, Once a day (QD) for up to 6 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • Tigulixostat 200mg
    • Tigulixostat 200mg, Once a day (QD) for up to 6 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • Tigulixostat 300mg
    • Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • Placebo
    • Placebo, Once a day (QD) for up to 6 months
  • Drug: 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

    Ages Eligible for Study 18 Years to 85 Years (Adult, Older Adult)
    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

    Sponsors and Collaborators LG Chem
    Locations
    • University of Alabama at Birmingham | Birmingham, Alabama, United States, 35249
    • Syed Research Consultants, LLC | Muscle Shoals, Alabama, United States, 35661
    • Medvin Clinical Research | Covina, California, United States, 91722
    • Clinical Research of West Florida, Inc. | Clearwater, Florida, United States, 33765
    • Herco Medical and Research Center, Inc | Coral Gables, Florida, United States, 33134
    • Direct Helpers Research Center | Hialeah, Florida, United States, 33012
    • Research Institute of South Florida, Inc. | Miami, Florida, United States, 33173
    • Clinical Research of West Florida, Inc. | Tampa, Florida, United States, 33606
    • Conquest Research, LLC | Winter Park, Florida, United States, 32789
    • Vista Clinical Research, LLC | Newnan, Georgia, United States, 30265
    • Velocity Clinical Research | Meridian, Idaho, United States, 83642
    • Healthcare Research Network II, LLC | Flossmoor, Illinois, United States, 60422
    • Alliance for Multispecialty Research, LLC | Lexington, Kentucky, United States, 40509
    • L-MARC Research Center | Louisville, Kentucky, United States, 40213
    • MD Medical Research | Oxon Hill, Maryland, United States, 20745
    • Elite Clinical Research, LLC | Jackson, Mississippi, United States, 39202
    • Olive Branch Family Medical Center | Olive Branch, Mississippi, United States, 38654
    • Practice Dr. David Headley | Port Gibson, Mississippi, United States, 39150
    • HealthCare Research | Hazelwood, Missouri, United States, 63042
    • Healor Primary Care/CCT Research | Las Vegas, Nevada, United States, 89102
    • Meridian Clinical Research, LLC | Vestal, New York, United States, 13850
    • Triad Clinical Trials | Greensboro, North Carolina, United States, 27410
    • STAT Research | Vandalia, Ohio, United States, 45377
    • Altoona Center for Clinical Research | Duncansville, Pennsylvania, United States, 16635
    • Tristar Clinical Investigations, P.C. | Philadelphia, Pennsylvania, United States, 19114
    • Velocity Clinical Research Greenville | Greenville, South Carolina, United States, 29615
    • PCCR Solutions | Colleyville, Texas, United States, 76034
    • Pioneer Research Solutions, Inc. | Houston, Texas, United States, 77099
    • Southwest Rheumatology Research LLC | Mesquite, Texas, United States, 75150
    • Endeavor Clinical Trials | San Antonio, Texas, United States, 78240
    • DM Clinical Research | Tomball, Texas, United States, 77377
    • Highland Clinical Research | Salt Lake City, Utah, United States, 84124
    • South Ogden Family Medicine/CCT Research | South Ogden, Utah, United States, 84405
    • Velocity Clinical Research, Salt Lake City | West Jordan, Utah, United States, 84088
    • Meridian Clinical Research, LLC | Portsmouth, Virginia, United States, 23703
    • Dominion Medical Associates, Inc. | Richmond, Virginia, United States, 23219
    • Clinical Research Partners, LLC | Richmond, Virginia, United States, 23226
    Investigators

      More Information

      Additional Relevant MeSH Terms

      • Gout
      • Hyperuricemia
      • Arthritis
      • Joint Diseases
      • Musculoskeletal Diseases
      • Crystal Arthropathies
      • Rheumatic Diseases
      • Purine-Pyrimidine Metabolism, Inborn Errors
      • Metabolism, Inborn Errors
      • Genetic Diseases, Inborn
      • Metabolic Diseases
      • Pathologic Processes