Clinical trial NCT05586958: Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gout
Hyperuricemia
Gout Flare
Tophi
Keywords: Gout
Hyperuricemia
Xanthine Oxidase Inhibitor
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
timeFrame: Up to Month 6
Secondary outcomes:
measure: The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
timeFrame: Up to Month 6
measure: The proportion of subjects reporting a gout flare up to each visit.
timeFrame: Up to Month 6
measure: Incidence rate of adverse event
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Muscle Shoals
country: United States
facility: Syed Research Consultants, LLC
state: Alabama
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center, Inc
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Winter Park
country: United States
facility: Conquest Research, LLC
state: Florida
city: Newnan
country: United States
facility: Vista Clinical Research, LLC
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Jackson
country: United States
facility: Elite Clinical Research, LLC
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Port Gibson
country: United States
facility: Practice Dr. David Headley
state: Mississippi
city: Hazelwood
country: United States
facility: HealthCare Research
state: Missouri
city: Las Vegas
country: United States
facility: Healor Primary Care/CCT Research
state: Nevada
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Vandalia
country: United States
facility: STAT Research
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations, P.C.
state: Pennsylvania
city: Greenville
country: United States
facility: Velocity Clinical Research Greenville
state: South Carolina
city: Colleyville
country: United States
facility: PCCR Solutions
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine/CCT Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Portsmouth
country: United States
facility: Meridian Clinical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates, Inc.
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
Study officials:
affiliation: LG Chem
name: Jisoo Lee, MD
role: STUDY_DIRECTOR
References: