Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
Key facts
- Where
- Birmingham, Clearwater, Colleyville, Coral Gables, Covina, Duncansville, Flossmoor, Greensboro, Greenville, Hazelwood, Hialeah, Houston, Jackson, Las Vegas, Lexington, Louisville, Meridian, Miami, Newnan, Olive Branch, Oxon Hill, Philadelphia, Port Gibson, Portsmouth, Richmond, Salt Lake City, San Antonio, South Ogden, Tampa, Tomball, Vandalia, Vestal, West Jordan, and Winter Park, United StatesSee the 36 sites
- Phase
- Phase 3
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Clinical Research of West Florida, Inc.Clearwater, United StatesNo longer taking part
- PCCR SolutionsColleyville, United StatesNo longer taking part
- Herco Medical and Research Center, IncCoral Gables, United StatesNo longer taking part
- Medvin Clinical ResearchCovina, United StatesNo longer taking part
- Altoona Center For Clinical ResearchDuncansville, United StatesNo longer taking part
- Healthcare Research Network II, LLCFlossmoor, United StatesNo longer taking part
- Triad Clinical TrialsGreensboro, United StatesNo longer taking part
- Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
- HealthCare ResearchHazelwood, United StatesNo longer taking part
- Direct Helpers Research CenterHialeah, United StatesNo longer taking part
- Pioneer Research Solutions, Inc.Houston, United StatesNo longer taking part
- Elite Clinical Research LLCJackson, United StatesNo longer taking part
- Healor Primary Care / CCT ResearchLas Vegas, United StatesNo longer taking part
- Alliance for Multispecialty Research, LLCLexington, United StatesNo longer taking part
- L-MARC Research CenterLouisville, United StatesNo longer taking part
- Velocity Clinical ResearchMeridian, United StatesNo longer taking part
- Allied Biomedical Research InstituteMiami, United StatesNo longer taking part
- Research Institute of South Florida, Inc.Miami, United StatesNo longer taking part
- Vista Clinical Research, LLCNewnan, United StatesNo longer taking part
- Olive Branch Family Medical CenterOlive Branch, United StatesNo longer taking part
- MD Medical ResearchOxon Hill, United StatesNo longer taking part
- Tristar Clinical Investigations, P.C.Philadelphia, United StatesNo longer taking part
- Practice Dr. David HeadleyPort Gibson, United StatesNo longer taking part
- Meridian Clinical Research, LLCPortsmouth, United StatesNo longer taking part
- Clinical Research Partners, LLCRichmond, United StatesNo longer taking part
- Dominion Medical Associates, Inc.Richmond, United StatesNo longer taking part
- Highland Clinical ResearchSalt Lake City, United StatesNo longer taking part
- Endeavor Clinical TrialsSan Antonio, United StatesNo longer taking part
- South Ogden Family Medicine/CCT ResearchSouth Ogden, United StatesNo longer taking part
- Clinical Research of West Florida IncTampa, United StatesNo longer taking part
- DM Clinical ResearchTomball, United StatesNo longer taking part
- STAT ResearchVandalia, United StatesNo longer taking part
- Meridian Clinical Research, LLCVestal, United StatesNo longer taking part
- Velocity Clinical Research, Salt Lake CityWest Jordan, United StatesNo longer taking part
- Conquest Research, LLCWinter Park, United StatesNo longer taking part
Trial details
- Who runs it
- LG Chem
- Trial code
- NCT05586958
- Record updated
- 29 October 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Subjects with secondary hyperuricemia, enzymatic defects.