Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
- Conditions
- GoutHyperuricemiaGout FlareTophi
- Interventions
- Drug: Placebo
- Registration Number
- NCT05586958
- Lead Sponsor
- LG Chem
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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, 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
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 6 months Tigulixostat 200mg Tigulixostat Tigulixostat 200mg, Once a day (QD) for up to 6 months Tigulixostat 300mg Tigulixostat Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months Placebo Placebo Placebo, Once a day (QD) for up to 6 months
- 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 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
Incidence rate of adverse event Up to Month 6 Safety assessment
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
Trial Locations
- Locations (35)
Meridian Clinical Research, LLC
🇺🇸Portsmouth, Virginia, United States
PCCR Solutions
🇺🇸Colleyville, Texas, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Healthcare Research Network II, LLC
🇺🇸Flossmoor, Illinois, United States
Conquest Research, LLC
🇺🇸Winter Park, Florida, United States
Velocity Clinical Research
🇺🇸Meridian, Idaho, United States
Practice Dr. David Headley
🇺🇸Port Gibson, Mississippi, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
STAT Research
🇺🇸Vandalia, Ohio, United States
Healor Primary Care/CCT Research
🇺🇸Las Vegas, Nevada, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Syed Research Consultants, LLC
🇺🇸Muscle Shoals, Alabama, United States
Medvin Clinical Research
🇺🇸Covina, California, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Vista Clinical Research, LLC
🇺🇸Newnan, Georgia, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Elite Clinical Research, LLC
🇺🇸Jackson, Mississippi, United States
HealthCare Research
🇺🇸Hazelwood, Missouri, United States
Tristar Clinical Investigations, P.C.
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Rheumatology Research LLC
🇺🇸Mesquite, Texas, United States
South Ogden Family Medicine/CCT Research
🇺🇸South Ogden, Utah, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Velocity Clinical Research Greenville
🇺🇸Greenville, South Carolina, United States
Alliance for Multispecialty Research, LLC
🇺🇸Lexington, Kentucky, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Herco Medical and Research Center, Inc
🇺🇸Coral Gables, Florida, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States