Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
LG Chem
Study ID
NCT05586971
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Tigulixostat — DRUG
    Xanthine Oxidase Inhibitor
  • Allopurinol — DRUG
    Xanthine Oxidase Inhibitor
  • Placebo — DRUG
    Matching placebo

Study Details

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.

Key Dates

First listed
Oct 19, 2022
Start date
Mar 30, 2023
Status verified
Jul 2025
Primary completion
May 6, 2025
Completion
May 6, 2025

Study Design

Enrollment
2,202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tigulixostat 100mg
    Tigulixostat 100mg, Once a day (QD) for up to 12 months
  • Experimental: Tigulixostat 200mg
    Tigulixostat 200mg, Once a day (QD) for up to 12 months
  • Experimental: Tigulixostat 300mg
    Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
  • Active Comparator: 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.
  • Placebo Comparator: Placebo
    Placebo, three times a day (TID) for up to 6 months.

Primary Outcome Measure

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

Locations (124)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Alliance for Multispecialty Research, LLCDaphneAlabama36526-
Alliance for Multispecialty Research, LLCMobileAlabama36608-
Syed Research Consultants, LLCMuscle ShoalsAlabama35661-
Syed Research Consultants, LLCSheffieldAlabama35660-
Arizona Research Clinic, PLLCChandlerArizona85225-
Arizona Arthritis & Rheumatology Associates, P.C.FlagstaffArizona86001-
Arizona Arthritis and Rheumatology Research PLLCGlendaleArizona85306-
Arizon Arthritis & Rheumatology Research, PLLCMesaArizona85210-
Desert Clinical Research/CCT ResearchMesaArizona85213-
Elite Clinical Studies, LLCPhoenixArizona85018-
Fiel Family and Sports Medicine/CCT ResearchTempeArizona85283-
Lynn Institute of the OzarksLittle RockArkansas72204-
Velocity Clinical ResearchBanningCalifornia92220-
American Clinical TrialsBuena ParkCalifornia90620-
Shreenath Clinical ServiceLakewoodCalifornia90805-
Rancho Cucamonga Clinical ResearchRancho CucamongaCalifornia91730-
Rheumatology Center of San DiegoSan DiegoCalifornia92128-
TriWest Research AssociatesSan DiegoCalifornia92108-
Arthritis & Rheumatic Disease SpecialtiesAventuraFlorida33180-
Clinical Research of West Florida, Inc.ClearwaterFlorida33765-
Herco Medical and Research Center, IncCoral GablesFlorida33134-
Nouvelle Clinical Research LLCCutler BayFlorida33189-
Omega Research Debary, LLCDeBaryFlorida32713-
Alliance for Multispecialty Research, LLCFort MyersFlorida33912-
Best Quality Research, IncHialeahFlorida33016-
Direct Helpers Research CenterHialeahFlorida33012-
New Generation Of Medical Research, LLCHialeahFlorida33016-
Vital Pharma ResearchHialeahFlorida33016-
Accel Research Sites - LakelandLake MaryFlorida32746-
Accel Research Sites - St. Petersburg- LargoLake MaryFlorida32746-
ARS-Matiland Clinical Research UnitLake MaryFlorida32746-
Allied Biomedical Research InstituteMiamiFlorida33155-
Care Research Center IncMiamiFlorida33175-
Clinical Site Partners, LLC dba Flourish ResearchMiamiFlorida33186-
D&H National Research Centers, Inc.MiamiFlorida33155-
Homestead Associates in Research,IncMiamiFlorida33032-
Ivetmar Medical Group, LLCMiamiFlorida33155-
M&A Medical Centers and ResearchMiamiFlorida33186-
Miami Dade Medical Research Institute, LLCMiamiFlorida33176-
Pharmax Research of South Florida, IncMiamiFlorida33175-
HMD Research LLCOrlandoFlorida32819-
IMA Clinical ResearchSt. PetersburgFlorida33709-
Adult Medicine of Lake County, Inc.TampaFlorida32757-
Clinical Research of West Florida, Inc.TampaFlorida33606-
Clinical Research Trials of Florida, Inc.TampaFlorida33607-
ForCare Clinical ResearchTampaFlorida33613-
Nodal Medical CenterTampaFlorida33607-
Research Institute of South Florida, Inc.TampaFlorida33173-
Clinical Site Partners LLC dba CSP OrlandoWinter ParkFlorida32789-
Conquest ResearchWinter ParkFlorida32789-
Centricity ResearchColumbusGeorgia31904-
Arthritis Center of North GeorgiaGainesvilleGeorgia30501-
Vista Clinical Research, LLCNewnanGeorgia30265-
East West Medical Research InstituteHonoluluHawaii96814-
Family Care Research, LLCBoiseIdaho83713-
Alliance for Multispecialty Research, LLCMeridianIdaho83642-
Great Lakes Clinical TrialsChicagoIllinois60640-
IMA Research, Inc.ChicagoIllinois60602-
Healthcare Research Network II, LLCFlossmoorIllinois60422-
Clinical Investigation Specialists, IncGurneeIllinois60031-
MediSphere Medical Research Center, LLCEvansvilleIndiana47714-
American Health Network of Indiana, LLCFranklinIndiana46131-
American Health Network of Indiana LLCMuncieIndiana47304-
Integrated Clinical Trial Services Inc.West Des MoinesIowa50265-
Women's & Family Care LLC, dba GTC ResearchShawnee MissionKansas66218-
Alliance for Multispecialty Research, LLCWichitaKansas67207-
Alliance for Multispecialty Research, LLCLexingtonKentucky40509-
Versailles Family MedicineVersaillesKentucky40383-
Clinical Trials Management, LLCCovingtonLouisiana70433-
Clinical Trials ManagementMetairieLouisiana70006-
MD Medical ResearchOxon HillMaryland20745-
Elite Clinical Research, LLCJacksonMississippi39202-
Olive Branch Family Medical CenterOlive BranchMississippi38654-
Practice Dr David HeadleyPort GibsonMississippi39150-
Healthcare Research NetworkHazelwoodMissouri63042-
Alliance for Multispecialty Research, LLCKansas CityMissouri64114-
Clay-Platte Family Medicine ClinicKansas CityMissouri64151-
IMA Clinical ResearchSt LouisMissouri63117-
St. Louis Medical Professionals, LLCSt LouisMissouri63119-
Montana Medical Research, Inc.MissoulaMontana59808-
Methodist Physicians Clinic/CCT ResearchFremontNebraska68025-
Meridian Clinical Research, LLCNorfolkNebraska68701-
Alliance for Multispecialty Research, LLC.Las VegasNevada89119-
Healor Primary Care /CCT ResearchLas VegasNevada89102-
Wake Research - CRCNLas VegasNevada89118-
Albuquerque Center for RheumatologyAlbuquerqueNew Mexico87102-
Inspire Santa Fe Medical GroupSanta FeNew Mexico87505-
Long Island Regional Arthritis & Osteoporosis Care PCBabylonNew York11702-
IMA Clinical ResearchNew YorkNew York10036-
Conquest ResearchVestalNew York13850-
Presbyterian HospitalCharlotteNorth Carolina28277-
Triad Clinical Trials, LLCGreensboroNorth Carolina27410-
Olympus Family MedicineHendersonvilleNorth Carolina28792-
Burke Primary CareMorgantonNorth Carolina28655-
Carolina Research Center, Inc.ShelbyNorth Carolina28150-
Lillestol Research LLCFargoNorth Dakota58104-
Trinity Health Center Medical ArtsMinotNorth Dakota58701-
Arthritis Associates of Northwest Ohio Inc.PerrysburgOhio43551-
STAT ResearchVandaliaOhio45377-
Hatboro Medical Associates, P.C.HatboroPennsylvania19040-
Tristar Clinical Investigations, P.C.PhiladelphiaPennsylvania19114-
Alliance for Multispecialty Research, LLCKnoxvilleTennessee37920-
New Phase ResearchKnoxvilleTennessee37909-
Inquest Clinical ResearchBaytownTexas77521-
PCCR SolutionsColleyvilleTexas76034-
DFW Clinical ResearchDallasTexas75234-
Metroplex Clinical Research CenterDallasTexas75231-
Dallas Fort Worth Clinical Research AssociatesFort WorthTexas76177-
Pioneer Research Solutions, Inc.HoustonTexas77099-
Southwest Rheumatology Research, LLCMesquiteTexas75150-
AIM Trials, LLCPlanoTexas75093-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Sugar Lakes Family Practice, PASugar LandTexas77479-
DM Clinical ResearchTomballTexas77375-
DM Clinical ResearchTomballTexas77377-
Cope Family Medicine/CCT ResearchBountifulUtah84010-
Highland Clinical ResearchSalt Lake CityUtah84124-
Olympus Family MedicineSalt Lake CityUtah84117-
South Ogden Family Medicine ClinicSouth OgdenUtah84405-
Velocity Clinical Research, Salt Lake CityWest JordanUtah84088-
Meridian Clinical Research, LLCPortsmouthVirginia23703-
Dominion Medical Associates, Inc.RichmondVirginia23219-
Arthritis Northwest, PLLCSpokaneWashington99204-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALAlliance for Multispecialty Research, LLC· Daphne, ALAlliance for Multispecialty Research, LLC· Mobile, ALSyed Research Consultants, LLC· Muscle Shoals, ALSyed Research Consultants, LLC· Sheffield, ALArizona Research Clinic, PLLC· Chandler, AZ

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