← Back to Search

XO Inhibitor

Tigulixostat for Gout (EURELIA2 Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by LG Chem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you a Male or Female 18 - 85 years of age?
Have you been diagnosed with GOUT?
Must not have
Do you have any uncontrolled pain not related to GOUT?
Have you received any oral steroids in the last 2 weeks?
Timeline
Screening 1 week
Treatment 12 months
Follow Up 2 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing Tigulixostat, a new medication, to see if it can help people with gout by lowering high levels of uric acid in their blood. The study focuses on gout patients who have high uric acid levels, which can lead to painful attacks. By reducing uric acid, Tigulixostat aims to prevent these painful episodes.

Who is the study for?
Adults aged 18-85 with gout and high uric acid levels are eligible for this trial. They must have a BMI ≤50 kg/m^2, kidney function (eGFR) ≥30 mL/min/1.73 m^2, and sUA level ≥6 mg/dL if on urate-lowering therapy or ≥7 mg/dL without it after washout. Excluded are those with xanthinuria, recent acute gout attacks, secondary hyperuricemia, enzymatic defects, or unstable medication affecting sUA.
What is being tested?
This study tests the effectiveness and safety of three doses of Tigulixostat compared to Allopurinol and placebo in managing gout over 12 months. It's randomized, double-blind (neither doctors nor patients know who gets which treatment), multi-regional with parallel groups.
What are the potential side effects?
While specific side effects for Tigulixostat aren't listed here, common side effects for gout medications include stomach pain, nausea, rash or itching; liver issues might also occur as well as possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have uncontrolled pain unrelated to gout.

Timeline

Screening ~ 1 week
Treatment ~ 12 months
Follow Up ~2 weeks
This trial's timeline: 1 week for screening, 12 months for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Secondary study objectives
Incidence rate of adverse event
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Tigulixostat 300mgExperimental Treatment1 Intervention
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
Group II: Tigulixostat 200mgExperimental Treatment1 Intervention
Tigulixostat 200mg, Once a day (QD) for up to 12 months
Group III: Tigulixostat 100mgExperimental Treatment1 Intervention
Tigulixostat 100mg, Once a day (QD) for up to 12 months
Group IV: Titrated allopurinol (100-800mg)Active Control1 Intervention
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.
Group V: PlaceboPlacebo Group1 Intervention
Placebo, three times a day (TID) for up to 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tigulixostat
2023
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

LG ChemLead Sponsor
65 Previous Clinical Trials
31,283 Total Patients Enrolled
Jisoo Lee, MDStudy DirectorLG Chem
2 Previous Clinical Trials
10,350 Total Patients Enrolled

Media Library

Tigulixostat (XO Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05586971 — Phase 3
Condition Research Study Groups: Tigulixostat 100mg, Tigulixostat 200mg, Tigulixostat 300mg, Titrated allopurinol (100-800mg), Placebo
Condition Clinical Trial 2023: Tigulixostat Highlights & Side Effects. Trial Name: NCT05586971 — Phase 3
Tigulixostat (XO Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05586971 — Phase 3
~471 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top