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

ClinicalTrials.gov processed this data on October 17, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

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

Sponsor

LG Chem

Information Provided by (Responsible Party)

LG Chem

Clinicaltrials.gov Identifier

NCT05586971
Other Study ID Numbers: LG-GDCL010
First Submitted: October 16, 2022
First Posted: October 19, 2022
Last Update Posted: October 18, 2023
Last Verified: October 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: Allopurinol
  • Drug: Placebo

Study Design

Study TypeInterventional
Anticipated Enrollment2542 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 30, 2023
Anticipated Primary Completion DateJuly 2025
Anticipated Study Completion DateDecember 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Tigulixostat 100mg
    • Tigulixostat 100mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • Tigulixostat 200mg
    • Tigulixostat 200mg, Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • Tigulixostat 300mg
    • Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
  • Drug: Tigulixostat
    • Xanthine Oxidase Inhibitor
  • 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
    • Placebo
      • Placebo, three times a day (TID) 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. Proportion of subjects with at least one gout flare from Month 6 to Month 12. [From Month 6 to Month 12]
        Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
      3. Proportion of subjects with complete resolution of ≥1 target tophus by Month 12 [Up to Month 12]
        Tophi will be measured by independent central blind reader
      4. Incidence rate of adverse event [Up to Month 12]
        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 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).

      Contacts and Locations

      Sponsors and Collaborators LG Chem
      Locations
      • University of Alabama at Birmingham | Birmingham, Alabama, United States, 35249
      • Alliance for Multispecialty Research, LLC | Daphne, Alabama, United States, 36526
      • Alliance for Multispecialty Research, LLC | Mobile, Alabama, United States, 36608
      • Syed Research Consultants, LLC | Muscle Shoals, Alabama, United States, 35661
      • Syed Research Consultants, LLC | Sheffield, Alabama, United States, 35660
      • Arizona Research Clinic, PLLC | Chandler, Arizona, United States, 85225
      • Arizona Arthritis & Rheumatology Associates, P.C. | Flagstaff, Arizona, United States, 86001
      • Arizona Arthritis and Rheumatology Research PLLC | Glendale, Arizona, United States, 85306
      • Arizon Arthritis & Rheumatology Research, PLLC | Mesa, Arizona, United States, 85210
      • Desert Clinical Research/CCT Research | Mesa, Arizona, United States, 85213
      • Elite Clinical Studies, LLC | Phoenix, Arizona, United States, 85018
      • Fiel Family and Sports Medicine/CCT Research | Tempe, Arizona, United States, 85283
      • Lynn Institute of the Ozarks | Little Rock, Arkansas, United States, 72204
      • Velocity Clinical Research | Banning, California, United States, 92220
      • American Clinical Trials | Buena Park, California, United States, 90620
      • Shreenath Clinical Service | Lakewood, California, United States, 90805
      • Rancho Cucamonga Clinical Research | Rancho Cucamonga, California, United States, 91730
      • TriWest Research Associates | San Diego, California, United States, 92108
      • Rheumatology Center of San Diego | San Diego, California, United States, 92128
      • Arthritis & Rheumatic Disease Specialties | Aventura, Florida, United States, 33180
      • Clinical Research of West Florida, Inc. | Clearwater, Florida, United States, 33765
      • Herco Medical and Research Center, Inc | Coral Gables, Florida, United States, 33134
      • Nouvelle Clinical Research LLC | Cutler Bay, Florida, United States, 33189
      • Omega Research Debary, LLC | DeBary, Florida, United States, 32713
      • Alliance for Multispecialty Research, LLC | Fort Myers, Florida, United States, 33912
      • Direct Helpers Research Center | Hialeah, Florida, United States, 33012
      • Best Quality Research, Inc | Hialeah, Florida, United States, 33016
      • New Generation Of Medical Research, LLC | Hialeah, Florida, United States, 33016
      • Vital Pharma Research | Hialeah, Florida, United States, 33016
      • Accel Research Sites - Lakeland | Lake Mary, Florida, United States, 32746
      • Accel Research Sites - St. Petersburg- Largo | Lake Mary, Florida, United States, 32746
      • ARS-Matiland Clinical Research Unit | Lake Mary, Florida, United States, 32746
      • Homestead Associates in Research,Inc | Miami, Florida, United States, 33032
      • Allied Biomedical Research Institute | Miami, Florida, United States, 33155
      • D&H National Research Centers, Inc. | Miami, Florida, United States, 33155
      • Ivetmar Medical Group, LLC | Miami, Florida, United States, 33155
      • Care Research Center Inc | Miami, Florida, United States, 33175
      • Pharmax Research of South Florida, Inc | Miami, Florida, United States, 33175
      • Miami Dade Medical Research Institute, LLC | Miami, Florida, United States, 33176
      • Clinical Site Partners, LLC dba Flourish Research | Miami, Florida, United States, 33186
      • M&A Medical Centers and Research | Miami, Florida, United States, 33186
      • HMD Research LLC | Orlando, Florida, United States, 32819
      • IMA Clinical Research | Saint Petersburg, Florida, United States, 33709
      • Adult Medicine of Lake County, Inc. | Tampa, Florida, United States, 32757
      • Research Institute of South Florida, Inc. | Tampa, Florida, United States, 33173
      • Clinical Research of West Florida, Inc. | Tampa, Florida, United States, 33606
      • Clinical Research Trials of Florida, Inc. | Tampa, Florida, United States, 33607
      • Nodal Medical Center | Tampa, Florida, United States, 33607
      • ForCare Clinical Research | Tampa, Florida, United States, 33613
      • Clinical Site Partners LLC dba CSP Orlando | Winter Park, Florida, United States, 32789
      • Conquest Research | Winter Park, Florida, United States, 32789
      • Centricity Research | Columbus, Georgia, United States, 31904
      • Arthritis Center of North Georgia | Gainesville, Georgia, United States, 30501
      • Vista Clinical Research, LLC | Newnan, Georgia, United States, 30265
      • East West Medical Research Institute | Honolulu, Hawaii, United States, 96814
      • Family Care Research, LLC | Boise, Idaho, United States, 83713
      • Alliance for Multispecialty Research, LLC | Meridian, Idaho, United States, 83642
      • IMA Research, Inc. | Chicago, Illinois, United States, 60602
      • Great Lakes Clinical Trials | Chicago, Illinois, United States, 60640
      • Healthcare Research Network II, LLC | Flossmoor, Illinois, United States, 60422
      • Clinical Investigation Specialists, Inc | Gurnee, Illinois, United States, 60031
      • MediSphere Medical Research Center, LLC | Evansville, Indiana, United States, 47714
      • American Health Network of Indiana, LLC | Franklin, Indiana, United States, 46131
      • American Health Network of Indiana LLC | Muncie, Indiana, United States, 47304
      • Integrated Clinical Trial Services Inc. | West Des Moines, Iowa, United States, 50265
      • Women's & Family Care LLC, dba GTC Research | Shawnee Mission, Kansas, United States, 66218
      • Alliance for Multispecialty Research, LLC | Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research, LLC | Lexington, Kentucky, United States, 40509
      • Omega Research Debary, LLC | Versailles, Kentucky, United States, 40383
      • Clinical Trials Management, LLC | Covington, Louisiana, United States, 70433
      • Clinical Trials Management | Metairie, Louisiana, United States, 70006
      • 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 Network | Hazelwood, Missouri, United States, 63042
      • Alliance for Multispecialty Research, LLC | Kansas City, Missouri, United States, 64114
      • Clay-Platte Family Medicine Clinic | Kansas City, Missouri, United States, 64151
      • IMA Clinical Research | Saint Louis, Missouri, United States, 63117
      • St. Louis Medical Professionals, LLC | Saint Louis, Missouri, United States, 63119
      • Montana Medical Research, Inc. | Missoula, Montana, United States, 59808
      • Methodist Physicians Clinic/CCT Research | Fremont, Nebraska, United States, 68025
      • Meridian Clinical Research, LLC | Norfolk, Nebraska, United States, 68701
      • Healor Primary Care /CCT Research | Las Vegas, Nevada, United States, 89102
      • Wake Research - CRCN | Las Vegas, Nevada, United States, 89118
      • Alliance for Multispecialty Research, LLC. | Las Vegas, Nevada, United States, 89119
      • Albuquerque Center for Rheumatology | Albuquerque, New Mexico, United States, 87102
      • Inspire Santa Fe Medical Group | Santa Fe, New Mexico, United States, 87505
      • Long Island Regional Arthritis & Osteoporosis Care PC | Babylon, New York, United States, 11702
      • IMA Clinical Research | New York, New York, United States, 10036
      • Conquest Research | Vestal, New York, United States, 13850
      • Presbyterian Hospital | Charlotte, North Carolina, United States, 28277
      • Triad Clinical Trials, LLC | Greensboro, North Carolina, United States, 27410
      • Olympus Family Medicine | Hendersonville, North Carolina, United States, 28792
      • Burke Primary Care | Morganton, North Carolina, United States, 28655
      • Carolina Research Center, Inc. | Shelby, North Carolina, United States, 28150
      • Lillestol Research LLC | Fargo, North Dakota, United States, 58104
      • Trinity Health Center Medical Arts | Minot, North Dakota, United States, 58701
      • Arthritis Associates of Northwest Ohio Inc. | Perrysburg, Ohio, United States, 43551
      • STAT Research | Vandalia, Ohio, United States, 45377
      • Hatboro Medical Associates, P.C. | Hatboro, Pennsylvania, United States, 19040
      • Tristar Clinical Investigations, P.C. | Philadelphia, Pennsylvania, United States, 19114
      • New Phase Research | Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Research, LLC | Knoxville, Tennessee, United States, 37920
      • Inquest Clinical Research | Baytown, Texas, United States, 77521
      • PCCR Solutions | Colleyville, Texas, United States, 76034
      • Metroplex Clinical Research Center | Dallas, Texas, United States, 75231
      • DFW Clinical Research | Dallas, Texas, United States, 75234
      • Dallas Fort Worth Clinical Research Associates | Fort Worth, Texas, United States, 76177
      • Pioneer Research Solutions, Inc. | Houston, Texas, United States, 77099
      • Southwest Rheumatology Research, LLC | Mesquite, Texas, United States, 75150
      • AIM Trials, LLC | Plano, Texas, United States, 75093
      • Clinical Trials of Texas, Inc. | San Antonio, Texas, United States, 78229
      • Sugar Lakes Family Practice, PA | Sugar Land, Texas, United States, 77479
      • DM Clinical Research | Tomball, Texas, United States, 77375
      • DM Clinical Research | Tomball, Texas, United States, 77377
      • Cope Family Medicine/CCT Research | Bountiful, Utah, United States, 84010
      • Olympus Family Medicine | Salt Lake City, Utah, United States, 84117
      • Highland Clinical Research | Salt Lake City, Utah, United States, 84124
      • South Ogden Family Medicine Clinic | 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
      • Arthritis Northwest, PLLC | Spokane, Washington, United States, 99204
      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