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Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients (EURELIA2)

Primary Purpose

Gout, Hyperuricemia, Gout Flare

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tigulixostat
Allopurinol
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 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).

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Syed Research Consultants, LLCRecruiting
  • Syed Research Consultants, LLCRecruiting
  • Arizona Research Clinic, PLLCRecruiting
  • Arizona Arthritis & Rheumatology Associates, P.C.Recruiting
  • Arizona Arthritis and Rheumatology Research PLLCRecruiting
  • Arizon Arthritis & Rheumatology Research, PLLCRecruiting
  • Desert Clinical Research/CCT ResearchRecruiting
  • Elite Clinical Studies, LLCRecruiting
  • Fiel Family and Sports Medicine/CCT ResearchRecruiting
  • Lynn Institute of the OzarksRecruiting
  • Velocity Clinical ResearchRecruiting
  • American Clinical TrialsRecruiting
  • Shreenath Clinical ServiceRecruiting
  • Rancho Cucamonga Clinical ResearchRecruiting
  • TriWest Research AssociatesRecruiting
  • Rheumatology Center of San DiegoRecruiting
  • Arthritis & Rheumatic Disease SpecialtiesRecruiting
  • Clinical Research of West Florida, Inc.Recruiting
  • Herco Medical and Research Center, IncRecruiting
  • Nouvelle Clinical Research LLCRecruiting
  • Omega Research Debary, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Direct Helpers Research CenterRecruiting
  • Best Quality Research, IncRecruiting
  • New Generation Of Medical Research, LLCRecruiting
  • Vital Pharma ResearchRecruiting
  • Accel Research Sites - LakelandRecruiting
  • Accel Research Sites - St. Petersburg- LargoRecruiting
  • ARS-Matiland Clinical Research UnitRecruiting
  • Homestead Associates in Research,IncRecruiting
  • Allied Biomedical Research InstituteRecruiting
  • D&H National Research Centers, Inc.Recruiting
  • Ivetmar Medical Group, LLCRecruiting
  • Care Research Center IncRecruiting
  • Pharmax Research of South Florida, IncRecruiting
  • Miami Dade Medical Research Institute, LLCRecruiting
  • Clinical Site Partners, LLC dba Flourish ResearchRecruiting
  • M&A Medical Centers and ResearchRecruiting
  • HMD Research LLCRecruiting
  • IMA Clinical ResearchRecruiting
  • Adult Medicine of Lake County, Inc.Recruiting
  • Research Institute of South Florida, Inc.Recruiting
  • Clinical Research of West Florida, Inc.Recruiting
  • Clinical Research Trials of Florida, Inc.Recruiting
  • Nodal Medical CenterRecruiting
  • ForCare Clinical ResearchRecruiting
  • Clinical Site Partners LLC dba CSP OrlandoRecruiting
  • Conquest ResearchRecruiting
  • Centricity ResearchRecruiting
  • Arthritis Center of North GeorgiaRecruiting
  • Vista Clinical Research, LLCRecruiting
  • East West Medical Research InstituteRecruiting
  • Family Care Research, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • IMA Research, Inc.Recruiting
  • Great Lakes Clinical TrialsRecruiting
  • Healthcare Research Network II, LLCRecruiting
  • Clinical Investigation Specialists, IncRecruiting
  • MediSphere Medical Research Center, LLCRecruiting
  • American Health Network of Indiana, LLCRecruiting
  • American Health Network of Indiana LLCRecruiting
  • Integrated Clinical Trial Services Inc.Recruiting
  • Women's & Family Care LLC, dba GTC ResearchRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Omega Research Debary, LLCRecruiting
  • Clinical Trials Management, LLCRecruiting
  • Clinical Trials ManagementRecruiting
  • MD Medical ResearchRecruiting
  • Elite Clinical Research, LLCRecruiting
  • Olive Branch Family Medical CenterRecruiting
  • Practice Dr David HeadleyRecruiting
  • Healthcare Research NetworkRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Clay-Platte Family Medicine ClinicRecruiting
  • IMA Clinical ResearchRecruiting
  • St. Louis Medical Professionals, LLCRecruiting
  • Montana Medical Research, Inc.Recruiting
  • Methodist Physicians Clinic/CCT ResearchRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Healor Primary Care /CCT ResearchRecruiting
  • Wake Research - CRCNRecruiting
  • Alliance for Multispecialty Research, LLC.Recruiting
  • Albuquerque Center for RheumatologyRecruiting
  • Inspire Santa Fe Medical GroupRecruiting
  • Long Island Regional Arthritis & Osteoporosis Care PCRecruiting
  • IMA Clinical ResearchRecruiting
  • Conquest ResearchRecruiting
  • Presbyterian HospitalRecruiting
  • Triad Clinical Trials, LLCRecruiting
  • Olympus Family MedicineRecruiting
  • Burke Primary CareRecruiting
  • Carolina Research Center, Inc.Recruiting
  • Lillestol Research LLCRecruiting
  • Trinity Health Center Medical ArtsRecruiting
  • Arthritis Associates of Northwest Ohio Inc.Recruiting
  • STAT ResearchRecruiting
  • Hatboro Medical Associates, P.C.Recruiting
  • Tristar Clinical Investigations, P.C.Recruiting
  • New Phase ResearchRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Inquest Clinical ResearchRecruiting
  • PCCR SolutionsRecruiting
  • Metroplex Clinical Research CenterRecruiting
  • DFW Clinical ResearchRecruiting
  • Dallas Fort Worth Clinical Research AssociatesRecruiting
  • Pioneer Research Solutions, Inc.Recruiting
  • Southwest Rheumatology Research, LLCRecruiting
  • AIM Trials, LLCRecruiting
  • Clinical Trials of Texas, Inc.Recruiting
  • Sugar Lakes Family Practice, PARecruiting
  • DM Clinical ResearchRecruiting
  • DM Clinical ResearchRecruiting
  • Cope Family Medicine/CCT ResearchRecruiting
  • Olympus Family MedicineRecruiting
  • Highland Clinical ResearchRecruiting
  • South Ogden Family Medicine ClinicRecruiting
  • Velocity Clinical Research, Salt Lake CityRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Dominion Medical Associates, Inc.Recruiting
  • Arthritis Northwest, PLLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Tigulixostat 100mg

Tigulixostat 200mg

Tigulixostat 300mg

Titrated allopurinol (100-800mg)

Placebo

Arm Description

Tigulixostat 100mg, Once a day (QD) for up to 12 months

Tigulixostat 200mg, Once a day (QD) for up to 12 months

Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months

Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.

Placebo, three times a day (TID) 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
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
Tophi will be measured by independent central blind reader
Incidence rate of adverse event
Safety assessment

Full Information

First Posted
October 16, 2022
Last Updated
October 17, 2023
Sponsor
LG Chem
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1. Study Identification

Unique Protocol Identification Number
NCT05586971
Brief Title
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Acronym
EURELIA2
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 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 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.

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
2542 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tigulixostat 100mg
Arm Type
Experimental
Arm Description
Tigulixostat 100mg, Once a day (QD) for up to 12 months
Arm Title
Tigulixostat 200mg
Arm Type
Experimental
Arm Description
Tigulixostat 200mg, Once a day (QD) for up to 12 months
Arm Title
Tigulixostat 300mg
Arm Type
Experimental
Arm Description
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
Arm Title
Titrated allopurinol (100-800mg)
Arm Type
Active Comparator
Arm Description
Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, three times a day (TID) 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)
Allopurinol
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
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Description
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
Time Frame
From Month 6 to Month 12
Title
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
Description
Tophi will be measured by independent central blind reader
Time Frame
Up to Month 12
Title
Incidence rate of adverse event
Description
Safety assessment
Time Frame
Up to Month 12

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 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).
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
Alliance for Multispecialty Research, LLC
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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
Syed Research Consultants, LLC
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Research Clinic, PLLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizon Arthritis & Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Name
Desert Clinical Research/CCT Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Individual Site Status
Recruiting
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Fiel Family and Sports Medicine/CCT Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Recruiting
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Individual Site Status
Recruiting
Facility Name
American Clinical Trials
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Individual Site Status
Recruiting
Facility Name
Shreenath Clinical Service
City
Lakewood
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Recruiting
Facility Name
Rancho Cucamonga Clinical Research
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
TriWest Research Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Center of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
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
Nouvelle Clinical Research LLC
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Debary, LLC
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
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
Best Quality Research, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
New Generation Of Medical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Pharma Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites - Lakeland
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites - St. Petersburg- Largo
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
ARS-Matiland Clinical Research Unit
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead Associates in Research,Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H National Research Centers, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Ivetmar Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Research Center Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmax Research of South Florida, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Dade Medical Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site Partners, LLC dba Flourish Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
M&A Medical Centers and Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
HMD Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Individual Site Status
Recruiting
Facility Name
Adult Medicine of Lake County, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Institute of South Florida, Inc.
City
Tampa
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
Clinical Research Trials of Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Nodal Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site Partners LLC dba CSP Orlando
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
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
East West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Care Research, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
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
Clinical Investigation Specialists, Inc
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Name
American Health Network of Indiana, LLC
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Individual Site Status
Recruiting
Facility Name
American Health Network of Indiana LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Individual Site Status
Recruiting
Facility Name
Integrated Clinical Trial Services Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Name
Women's & Family Care LLC, dba GTC Research
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
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
Omega Research Debary, LLC
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management, LLC
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
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 Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Individual Site Status
Recruiting
Facility Name
Clay-Platte Family Medicine Clinic
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Louis Medical Professionals, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Individual Site Status
Recruiting
Facility Name
Montana Medical Research, Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist Physicians Clinic/CCT Research
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
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
Wake Research - CRCN
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Inspire Santa Fe Medical Group
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Recruiting
Facility Name
Long Island Regional Arthritis & Osteoporosis Care PC
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Name
Conquest Research
City
Vestal
State/Province
New York
ZIP/Postal Code
13850
Country
United States
Individual Site Status
Recruiting
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Triad Clinical Trials, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympus Family Medicine
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28792
Country
United States
Individual Site Status
Recruiting
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center, Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Health Center Medical Arts
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Associates of Northwest Ohio Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
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
Hatboro Medical Associates, P.C.
City
Hatboro
State/Province
Pennsylvania
ZIP/Postal Code
19040
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
New Phase Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
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
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
DFW Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Name
Dallas Fort Worth Clinical Research Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
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
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Sugar Lakes Family Practice, PA
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
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
Cope Family Medicine/CCT Research
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Name
Olympus Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
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 Clinic
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
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
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, Allopurinol Controlled in Gout Patients

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