Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
- Conditions
- HyperuricemiaGoutGout FlareTophi
- Interventions
- Registration Number
- NCT05586971
- Lead Sponsor
- LG Chem
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2202
- 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).
- 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 Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tigulixostat 100mg Tigulixostat Tigulixostat 100mg, Once a day (QD) for up to 12 months Tigulixostat 200mg Tigulixostat Tigulixostat 200mg, Once a day (QD) for up to 12 months Placebo Placebo Placebo, three times a day (TID) for up to 6 months. Tigulixostat 300mg Tigulixostat Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months Titrated allopurinol (100-800mg) Allopurinol 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence rate of adverse event Up to Month 12 Safety assessment
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
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
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
Trial Locations
- Locations (109)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Syed Research Consultants, LLC
🇺🇸Sheffield, Alabama, United States
Arizona Research Clinic, PLLC
🇺🇸Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Research PLLC
🇺🇸Glendale, Arizona, United States
Arizon Arthritis & Rheumatology Research, PLLC
🇺🇸Mesa, Arizona, United States
Desert Clinical Research/CCT Research
🇺🇸Mesa, Arizona, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Fiel Family and Sports Medicine/CCT Research
🇺🇸Tempe, Arizona, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Velocity Clinical Research
🇺🇸Banning, California, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Shreenath Clinical Service
🇺🇸Lakewood, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
TriWest Research Associates
🇺🇸San Diego, California, United States
Rheumatology Center of San Diego
🇺🇸San Diego, California, United States
Arthritis & Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
New Generation Of Medical Research, LLC
🇺🇸Hialeah, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Herco Medical and Research Center, Inc
🇺🇸Coral Gables, Florida, United States
Nouvelle Clinical Research LLC
🇺🇸Cutler Bay, Florida, United States
Omega Research Debary, LLC
🇺🇸DeBary, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Best Quality Research, Inc
🇺🇸Hialeah, Florida, United States
Vital Pharma Research
🇺🇸Hialeah, Florida, United States
Accel Research Sites - Lakeland
🇺🇸Lake Mary, Florida, United States
Accel Research Sites - St. Petersburg- Largo
🇺🇸Lake Mary, Florida, United States
ARS-Matiland Clinical Research Unit
🇺🇸Lake Mary, Florida, United States
Homestead Associates in Research,Inc
🇺🇸Miami, Florida, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
D&H National Research Centers, Inc.
🇺🇸Miami, Florida, United States
Ivetmar Medical Group, LLC
🇺🇸Miami, Florida, United States
Care Research Center Inc
🇺🇸Miami, Florida, United States
Pharmax Research of South Florida, Inc
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
🇺🇸Miami, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Miami, Florida, United States
M&A Medical Centers and Research
🇺🇸Miami, Florida, United States
HMD Research LLC
🇺🇸Orlando, Florida, United States
IMA Clinical Research
🇺🇸New York, New York, United States
Adult Medicine of Lake County, Inc.
🇺🇸Tampa, Florida, United States
Research Institute of South Florida, Inc.
🇺🇸Tampa, Florida, United States
Clinical Research Trials of Florida, Inc.
🇺🇸Tampa, Florida, United States
Nodal Medical Center
🇺🇸Tampa, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Clinical Site Partners LLC dba CSP Orlando
🇺🇸Winter Park, Florida, United States
Conquest Research
🇺🇸Vestal, New York, United States
Centricity Research
🇺🇸Columbus, Georgia, United States
Arthritis Center of North Georgia
🇺🇸Gainesville, Georgia, United States
Vista Clinical Research, LLC
🇺🇸Newnan, Georgia, United States
East West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Family Care Research, LLC
🇺🇸Boise, Idaho, United States
IMA Research, Inc.
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Clinical Investigation Specialists, Inc
🇺🇸Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
American Health Network of Indiana, LLC
🇺🇸Franklin, Indiana, United States
American Health Network of Indiana LLC
🇺🇸Muncie, Indiana, United States
Integrated Clinical Trial Services Inc.
🇺🇸West Des Moines, Iowa, United States
Women's & Family Care LLC, dba GTC Research
🇺🇸Shawnee, Kansas, United States
Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Clinical Trials Management, LLC
🇺🇸Covington, Louisiana, United States
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Elite Clinical Research, LLC
🇺🇸Jackson, Mississippi, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Practice Dr David Headley
🇺🇸Port Gibson, Mississippi, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Clay-Platte Family Medicine Clinic
🇺🇸Kansas City, Missouri, United States
St. Louis Medical Professionals, LLC
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Methodist Physicians Clinic/CCT Research
🇺🇸Fremont, Nebraska, United States
Meridian Clinical Research, LLC
🇺🇸Portsmouth, Virginia, United States
Healor Primary Care /CCT Research
🇺🇸Las Vegas, Nevada, United States
Hatboro Medical Associates, P.C.
🇺🇸Hatboro, Pennsylvania, United States
Wake Research - CRCN
🇺🇸Las Vegas, Nevada, United States
Alliance for Multispecialty Research, LLC.
🇺🇸Las Vegas, Nevada, United States
Albuquerque Center for Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Inspire Santa Fe Medical Group
🇺🇸Santa Fe, New Mexico, United States
Long Island Regional Arthritis & Osteoporosis Care PC
🇺🇸Babylon, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Triad Clinical Trials, LLC
🇺🇸Greensboro, North Carolina, United States
Olympus Family Medicine
🇺🇸Salt Lake City, Utah, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Carolina Research Center, Inc.
🇺🇸Shelby, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Trinity Health Center Medical Arts
🇺🇸Minot, North Dakota, United States
Arthritis Associates of Northwest Ohio Inc.
🇺🇸Perrysburg, Ohio, United States
STAT Research
🇺🇸Vandalia, Ohio, United States
Tristar Clinical Investigations, P.C.
🇺🇸Philadelphia, Pennsylvania, United States
New Phase Research
🇺🇸Knoxville, Tennessee, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
PCCR Solutions
🇺🇸Colleyville, Texas, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
DFW Clinical Research
🇺🇸Dallas, Texas, United States
Dallas Fort Worth Clinical Research Associates
🇺🇸Fort Worth, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Southwest Rheumatology Research, LLC
🇺🇸Mesquite, Texas, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice, PA
🇺🇸Sugar Land, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Cope Family Medicine/CCT Research
🇺🇸Bountiful, Utah, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
South Ogden Family Medicine Clinic
🇺🇸South Ogden, Utah, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States