Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Gout Clinical Trial

— EURELIA1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586958
• Other study ID #: LG-GDCL009
• Status: Recruiting
• Phase: Phase 3
• Start date: October 25, 2022
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: LG Chem
• Contact: Younghwan Jang
• Phone: +82-2-6987-4154
• Email: younghj[@]lgchem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

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

Related Conditions & MeSH terms

• Gout
• Gout Flare
• Hyperuricemia

Intervention

Drug:
• Tigulixostat
Xanthine Oxidase Inhibitor
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Clinical Research of West Florida, Inc.	Clearwater	Florida
United States	PCCR Solutions	Colleyville	Texas
United States	Herco Medical and Research Center, Inc	Coral Gables	Florida
United States	Medvin Clinical Research	Covina	California
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Healthcare Research Network II, LLC	Flossmoor	Illinois
United States	Triad Clinical Trials	Greensboro	North Carolina
United States	Velocity Clinical Research Greenville	Greenville	South Carolina
United States	HealthCare Research	Hazelwood	Missouri
United States	Direct Helpers Research Center	Hialeah	Florida
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Elite Clinical Research, LLC	Jackson	Mississippi
United States	Healor Primary Care/CCT Research	Las Vegas	Nevada
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	L-MARC Research Center	Louisville	Kentucky
United States	Velocity Clinical Research	Meridian	Idaho
United States	Southwest Rheumatology Research LLC	Mesquite	Texas
United States	Research Institute of South Florida, Inc.	Miami	Florida
United States	Syed Research Consultants, LLC	Muscle Shoals	Alabama
United States	Vista Clinical Research, LLC	Newnan	Georgia
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	MD Medical Research	Oxon Hill	Maryland
United States	Tristar Clinical Investigations, P.C.	Philadelphia	Pennsylvania
United States	Practice Dr. David Headley	Port Gibson	Mississippi
United States	Meridian Clinical Research, LLC	Portsmouth	Virginia
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Dominion Medical Associates, Inc.	Richmond	Virginia
United States	Highland Clinical Research	Salt Lake City	Utah
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	South Ogden Family Medicine/CCT Research	South Ogden	Utah
United States	Clinical Research of West Florida, Inc.	Tampa	Florida
United States	DM Clinical Research	Tomball	Texas
United States	STAT Research	Vandalia	Ohio
United States	Meridian Clinical Research, LLC	Vestal	New York
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Conquest Research, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence rate of adverse event	Safety assessment	Up to Month 6