EURELIA2: Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tigulixostat 100mg Tigulixostat 100mg, Once a day (QD) for up to 12 months |
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
|
| Experimental: Tigulixostat 200mg Tigulixostat 200mg, Once a day (QD) for up to 12 months |
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
|
| Experimental: Tigulixostat 300mg Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months |
Drug: Tigulixostat
Xanthine Oxidase Inhibitor
Other Names:
|
| Active Comparator: Titrated allopurinol (100-800mg) Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg. |
Drug: Allopurinol
Xanthine Oxidase Inhibitor
|
| Placebo Comparator: Placebo Placebo, three times a day (TID) for up to 6 months. |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Proportion of subjects with at least one gout flare from Month 6 to Month 12. [From Month 6 to Month 12]
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
- Proportion of subjects with complete resolution of ≥1 target tophus by Month 12 [Up to Month 12]
Tophi will be measured by independent central blind reader
- Incidence rate of adverse event [Up to Month 12]
Safety assessment
Eligibility Criteria
Criteria
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 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).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- LG Chem
Investigators
- Study Director: Jisoo Lee, MD, LG Chem
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LG-GDCL010