Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

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
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
Incidence rate of adverse event	Up to Month 6	Safety assessment

Locations (50): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Medvin Clinical Research
🇺🇸
Covina, California, United States
Clinical Research of West Florida, Inc.
🇺🇸
Tampa, 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
Conquest Research, LLC
🇺🇸
Winter Park, Florida, United States
Vista Clinical Research, LLC
🇺🇸
Newnan, Georgia, United States
Velocity Clinical Research
🇺🇸
Meridian, Idaho, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States