Overview

A Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia

Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
LG Chem
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