search
Back to results

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients (EURELIA1)

Primary Purpose

Gout, Hyperuricemia, Gout Flare

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tigulixostat
Placebo
Sponsored by
LG Chem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout, Hyperuricemia, Xanthine Oxidase Inhibitor

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Syed Research Consultants, LLCRecruiting
  • Medvin Clinical ResearchRecruiting
  • Clinical Research of West Florida, Inc.Recruiting
  • Herco Medical and Research Center, IncRecruiting
  • Direct Helpers Research CenterRecruiting
  • Research Institute of South Florida, Inc.Recruiting
  • Clinical Research of West Florida, Inc.Recruiting
  • Conquest Research, LLCRecruiting
  • Vista Clinical Research, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Healthcare Research Network II, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • L-MARC Research CenterRecruiting
  • MD Medical ResearchRecruiting
  • Elite Clinical Research, LLCRecruiting
  • Olive Branch Family Medical CenterRecruiting
  • Practice Dr. David HeadleyRecruiting
  • HealthCare ResearchRecruiting
  • Healor Primary Care/CCT ResearchRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Triad Clinical TrialsRecruiting
  • STAT ResearchRecruiting
  • Altoona Center for Clinical ResearchRecruiting
  • Tristar Clinical Investigations, P.C.Recruiting
  • Velocity Clinical Research GreenvilleRecruiting
  • PCCR SolutionsRecruiting
  • Pioneer Research Solutions, Inc.Recruiting
  • Southwest Rheumatology Research LLCRecruiting
  • Endeavor Clinical TrialsRecruiting
  • DM Clinical ResearchRecruiting
  • Highland Clinical ResearchRecruiting
  • South Ogden Family Medicine/CCT ResearchRecruiting
  • Velocity Clinical Research, Salt Lake CityRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Dominion Medical Associates, Inc.Recruiting
  • Clinical Research Partners, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tigulixostat 100mg

Tigulixostat 200mg

Tigulixostat 300mg

Placebo

Arm Description

Tigulixostat 100mg, Once a day (QD) for up to 6 months

Tigulixostat 200mg, Once a day (QD) for up to 6 months

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months

Placebo, Once a day (QD) for up to 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Incidence rate of adverse event
Safety assessment

Full Information

First Posted
October 16, 2022
Last Updated
August 24, 2023
Sponsor
LG Chem
search

1. Study Identification

Unique Protocol Identification Number
NCT05586958
Brief Title
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia, Gout Flare, Tophi
Keywords
Gout, Hyperuricemia, Xanthine Oxidase Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tigulixostat 100mg
Arm Type
Experimental
Arm Description
Tigulixostat 100mg, Once a day (QD) for up to 6 months
Arm Title
Tigulixostat 200mg
Arm Type
Experimental
Arm Description
Tigulixostat 200mg, Once a day (QD) for up to 6 months
Arm Title
Tigulixostat 300mg
Arm Type
Experimental
Arm Description
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, Once a day (QD) for up to 6 months
Intervention Type
Drug
Intervention Name(s)
Tigulixostat
Other Intervention Name(s)
LC350189
Intervention Description
Xanthine Oxidase Inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Description
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Time Frame
Up to Month 6
Secondary Outcome Measure Information:
Title
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
Description
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Time Frame
Up to Month 6
Title
The proportion of subjects reporting a gout flare up to each visit.
Description
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 6 months
Time Frame
Up to Month 6
Title
Incidence rate of adverse event
Description
Safety assessment
Time Frame
Up to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Younghwan Jang
Phone
+82-2-6987-4154
Email
younghj@lgchem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jisoo Lee, MD
Organizational Affiliation
LG Chem
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Name
Syed Research Consultants, LLC
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Individual Site Status
Recruiting
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Herco Medical and Research Center, Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Institute of South Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Vista Clinical Research, LLC
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Healthcare Research Network II, LLC
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Individual Site Status
Recruiting
Facility Name
Elite Clinical Research, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Individual Site Status
Recruiting
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Individual Site Status
Recruiting
Facility Name
Practice Dr. David Headley
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Individual Site Status
Recruiting
Facility Name
HealthCare Research
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Individual Site Status
Recruiting
Facility Name
Healor Primary Care/CCT Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Individual Site Status
Recruiting
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Individual Site Status
Recruiting
Facility Name
STAT Research
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Individual Site Status
Recruiting
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Tristar Clinical Investigations, P.C.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
PCCR Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77377
Country
United States
Individual Site Status
Recruiting
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Name
South Ogden Family Medicine/CCT Research
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Salt Lake City
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703
Country
United States
Individual Site Status
Recruiting
Facility Name
Dominion Medical Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

We'll reach out to this number within 24 hrs