Clinical trial NCT05586971: Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Official title: A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2202
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 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.


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 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).

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: Proportion of subjects with at least one gout flare from Month 6 to Month 12.
timeFrame: From Month 6 to Month 12
measure: Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
timeFrame: Up to Month 12
measure: Incidence rate of adverse event
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Daphne
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Muscle Shoals
country: United States
facility: Syed Research Consultants, LLC
state: Alabama
city: Sheffield
country: United States
facility: Syed Research Consultants, LLC
state: Alabama
city: Chandler
country: United States
facility: Arizona Research Clinic, PLLC
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Mesa
country: United States
facility: Arizon Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research/CCT Research
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine/CCT Research
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Banning
country: United States
facility: Velocity Clinical Research
state: California
city: Buena Park
country: United States
facility: American Clinical Trials
state: California
city: Lakewood
country: United States
facility: Shreenath Clinical Service
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: San Diego
country: United States
facility: TriWest Research Associates
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
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: Cutler Bay
country: United States
facility: Nouvelle Clinical Research LLC
state: Florida
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc
state: Florida
city: Hialeah
country: United States
facility: New Generation Of Medical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Vital Pharma Research
state: Florida
city: Lake Mary
country: United States
facility: Accel Research Sites - Lakeland
state: Florida
city: Lake Mary
country: United States
facility: Accel Research Sites - St. Petersburg- Largo
state: Florida
city: Lake Mary
country: United States
facility: ARS-Matiland Clinical Research Unit
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research,Inc
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers, Inc.
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Care Research Center Inc
state: Florida
city: Miami
country: United States
facility: Pharmax Research of South Florida, Inc
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Miami
country: United States
facility: M&A Medical Centers and Research
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC
state: Florida
city: Saint Petersburg
country: United States
facility: IMA Clinical Research
state: Florida
city: Tampa
country: United States
facility: Adult Medicine of Lake County, Inc.
state: Florida
city: Tampa
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: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners LLC dba CSP Orlando
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Newnan
country: United States
facility: Vista Clinical Research, LLC
state: Georgia
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Boise
country: United States
facility: Family Care Research, LLC
state: Idaho
city: Meridian
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Idaho
city: Chicago
country: United States
facility: IMA Research, Inc.
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services Inc.
state: Iowa
city: Shawnee
country: United States
facility: Women's & Family Care LLC, dba GTC Research
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Versailles
country: United States
facility: Versailles Family Medicine
state: Kentucky
city: Covington
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Metairie
country: United States
facility: Clinical Trials Management
state: Louisiana
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 Network
state: Missouri
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Missouri
city: Kansas City
country: United States
facility: Clay-Platte Family Medicine Clinic
state: Missouri
city: Saint Louis
country: United States
facility: IMA Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Medical Professionals, LLC
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc.
state: Montana
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Healor Primary Care /CCT Research
state: Nevada
city: Las Vegas
country: United States
facility: Wake Research - CRCN
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC.
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Santa Fe
country: United States
facility: Inspire Santa Fe Medical Group
state: New Mexico
city: Babylon
country: United States
facility: Long Island Regional Arthritis & Osteoporosis Care PC
state: New York
city: New York
country: United States
facility: IMA Clinical Research
state: New York
city: Vestal
country: United States
facility: Conquest Research
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials, LLC
state: North Carolina
city: Hendersonville
country: United States
facility: Olympus Family Medicine
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Minot
country: United States
facility: Trinity Health Center Medical Arts
state: North Dakota
city: Perrysburg
country: United States
facility: Arthritis Associates of Northwest Ohio Inc.
state: Ohio
city: Vandalia
country: United States
facility: STAT Research
state: Ohio
city: Hatboro
country: United States
facility: Hatboro Medical Associates, P.C.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations, P.C.
state: Pennsylvania
city: Knoxville
country: United States
facility: New Phase Research
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Colleyville
country: United States
facility: PCCR Solutions
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: DFW Clinical Research
state: Texas
city: Fort Worth
country: United States
facility: Dallas Fort Worth Clinical Research Associates
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: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice, PA
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine/CCT Research
state: Utah
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: South Ogden
country: United States
facility: South Ogden Family Medicine Clinic
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: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
Study officials:
affiliation: LG Chem
name: Hyungjin Cho, MD
role: STUDY_DIRECTOR
References: