Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Gout, Hyperuricemia, Gout Flare, Tophi

In brief

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 facts

Study ID

NCT05586971

Run by

LG Chem

People needed

2202

Starts

2023-03-30

Expected to finish

2025-05-06

Last updated by the study team

2025-07-22

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 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).

Where it is running

• MICS Centrum Medyczne Warszawa — Warsaw, Poland
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Alliance for Multispecialty Research, LLC — Daphne, Alabama, United States
• Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
• Syed Research Consultants, LLC — Muscle Shoals, Alabama, 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
• FutureMeds Warszawa Centrum — Warsaw, Poland
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Herco Medical and Research Center, Inc — Coral Gables, Florida, United States
• Elite Clinical Research, LLC — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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