Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Gout, Hyperuricemia, Gout Flare, Tophi

In brief

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.

Key facts

Study ID

NCT05586958

Run by

LG Chem

People needed

354

Starts

2022-10-25

Expected to finish

2024-12-16

Last updated by the study team

2025-10-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Medvin Clinical Research — Covina, California, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Herco Medical and Research Center, Inc — Coral Gables, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• Research Institute of South Florida, Inc. — Miami, Florida, United States
• Clinical Research of West Florida, Inc. — Tampa, Florida, United States
• Conquest Research, LLC — Winter Park, Florida, United States
• Vista Clinical Research, LLC — Newnan, Georgia, United States
• Velocity Clinical Research — Meridian, Idaho, United States
• Healthcare Research Network II, LLC — Flossmoor, Illinois, United States
• Alliance for Multispecialty Research, LLC — Lexington, Kentucky, United States
• L-MARC Research Center — Louisville, Kentucky, 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 — Hazelwood, Missouri, United States
• Healor Primary Care/CCT Research — Las Vegas, Nevada, United States
• Meridian Clinical Research, LLC — Vestal, New York, United States
• Triad Clinical Trials — Greensboro, North Carolina, United States
• STAT Research — Vandalia, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Tristar Clinical Investigations, P.C. — Philadelphia, Pennsylvania, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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