Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Launched by LG CHEM · Oct 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Tigulixostat to see how effective it is in treating gout, a painful condition caused by high levels of uric acid in the body, leading to symptoms like joint pain and swelling. The study will last for six months and will compare the effects of three different doses of Tigulixostat to a placebo (a pill with no active ingredients) in patients who have high uric acid levels and a history of gout.

To participate in the trial, individuals must be between 18 and 85 years old and have high uric acid levels, either while on gout medications or not. They should not have had a recent gout flare-up or other specific health issues. Participants can expect to take the study medication, attend regular check-ups, and help researchers learn more about how Tigulixostat works for gout. This study is currently looking for volunteers, and it is important for anyone interested to discuss with their doctor to see if they qualify.

Gender

ALL

Eligibility 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, 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