Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gout, Hyperuricemia, Gout Flare, Tophi

Intervention / Treatment
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* Drug: Tigulixostat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tigulixostat 100mg<br>Tigulixostat 100mg, Once a day (QD) for up to 6 months | Drug: Tigulixostat<br>* Xanthine Oxidase Inhibitor<br>* Other names: LC350189;|
| Experimental: Tigulixostat 200mg<br>Tigulixostat 200mg, Once a day (QD) for up to 6 months | Drug: Tigulixostat<br>* Xanthine Oxidase Inhibitor<br>* Other names: LC350189;|
| Experimental: Tigulixostat 300mg<br>Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months | Drug: Tigulixostat<br>* Xanthine Oxidase Inhibitor<br>* Other names: LC350189;|
| Placebo Comparator: Placebo<br>Placebo, Once a day (QD) for up to 6 months | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 | Serum uric acid (sUA) level will be measured at Month 4,5, and 6 | Up to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 | Serum uric acid (sUA) level will be measured at Month 4,5, and 6 | Up to Month 6 | 
| The proportion of subjects reporting a gout flare up to each visit. | Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months | Up to Month 6 | 
| Incidence rate of adverse event | Safety assessment | Up to Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Hyperuricemia, Xanthine Oxidase Inhibitor