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

ClinicalTrials.gov processed this data on October 17, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified October 2023 by LG Chem

Sponsor

LG Chem

Information Provided by (Responsible Party)

LG Chem

Clinicaltrials.gov Identifier

NCT05586971
Other Study ID Numbers: LG-GDCL010
First Submitted: October 16, 2022
First Posted: October 19, 2022
Last Update Posted: October 18, 2023
Last Verified: October 2023
History of Changes

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Tracking Information
First Submitted DateOctober 16, 2022
First Posted DateOctober 19, 2022
Last Update Posted DateOctober 18, 2023
Study Start DateMarch 30, 2023
Anticipated Primary Completion DateJuly 2025
Current Primary Outcome Measures
(submitted: October 17, 2023)
  1. The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6 [Up to Month 6]
    Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Change HistoryComplete list of historical versions of study NCT05586971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
  1. The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6 [Up to Month 6]
    Serum uric acid (sUA) level will be measured at Month 4,5, and 6
  2. Proportion of subjects with at least one gout flare from Month 6 to Month 12. [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
  3. Proportion of subjects with complete resolution of ≥1 target tophus by Month 12 [Up to Month 12]
    Tophi will be measured by independent central blind reader
  4. Incidence rate of adverse event [Up to Month 12]
    Safety assessment
Current Other Outcome MeasuresNot Provided
Descriptive Information
Brief TitleTigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Official TitleA 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple
Primary Purpose: Treatment
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
Condition
  • Gout
  • Hyperuricemia
  • Gout Flare
  • Tophi
Intervention

Drug: Tigulixostat

Xanthine Oxidase Inhibitor

Study Groups/Cohorts

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

Intervention:
  • Drug: Tigulixostat

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

Intervention:
  • Drug: Tigulixostat

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

Intervention:
  • Drug: Tigulixostat

Active Comparator: Titrated allopurinol (100-800mg)
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.

Intervention:
  • Drug: Allopurinol

Placebo Comparator: Placebo
Placebo, three times a day (TID) for up to 6 months.

Intervention:
  • Drug: Placebo
Publications *Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment
(submitted: October 17, 2023)		2542
Anticipated Study Completion DateDecember 2025
Anticipated Primary Study Completion DateJuly 2025
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).

Sex/GenderSexes Eligible for Study: All
Ages18 Years to 85 Years (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts

Contact: Younghwan Jang, phone: +82-2-6987-4154, email: younghj@lgchem.com

Listed Location CountriesUnited States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States
Administrative Information
NCT NumberNCT05586971
Other Study ID NumbersLG-GDCL010
Has Data Monitoring CommitteeYes
U.S FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No

Product Manufactured in and Exported from the U.S.: Not Provided

IPD Sharing StatementPlan to Share IPD: No
Responsible PartyLG Chem, LG Chem
Study SponsorLG Chem
CollaboratorsNot Provided
Investigators
PRS AccountLG Chem
Verification DateOctober 2023