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XO Inhibitor

Tigulixostat for Gout (EURELIA1 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
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights

EURELIA1 Trial Summary

This trial will test a new drug to see if it's safe and effective in treating gout, a painful joint condition.

Who is the study for?
Adults aged 18-85 with gout and high uric acid levels are eligible for this trial. They must meet specific criteria for hyperuricemia, have a BMI ≤50 kg/m2, and an eGFR ≥30 mL/min/1.73 m2. Those on urate-lowering therapies need to reach certain uric acid levels after washout to participate.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of Tigulixostat at three different doses compared to a placebo in treating gout patients over six months. Participants will be randomly assigned to either the medication or placebo group.See study design
What are the potential side effects?
While specific side effects of Tigulixostat aren't listed here, common side effects in similar medications include stomach pain, nausea, rash, liver issues, and more frequent gout attacks initially.

EURELIA1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have high uric acid levels and gout according to ACR/EULAR 2015.
Select...
My uric acid levels are high, even with or without gout medication.
Select...
My BMI is 50 or less and my kidney function is good.
Select...
I have high uric acid levels and gout according to ACR/EULAR 2015.
Select...
My uric acid levels are high despite taking or not taking urate-lowering medication.
Select...
My BMI is 50 or less and my kidney function is adequate.

EURELIA1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Secondary outcome measures
Incidence rate of adverse event
The proportion of subjects reporting a gout flare up to each visit.
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6

EURELIA1 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Tigulixostat 300mgExperimental Treatment1 Intervention
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 6 months
Group II: Tigulixostat 200mgExperimental Treatment1 Intervention
Tigulixostat 200mg, Once a day (QD) for up to 6 months
Group III: Tigulixostat 100mgExperimental Treatment1 Intervention
Tigulixostat 100mg, Once a day (QD) for up to 6 months
Group IV: PlaceboPlacebo Group1 Intervention
Placebo, Once a day (QD) for up to 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tigulixostat
2023
Completed Phase 1
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Xanthine oxidase inhibitors (XOIs) like allopurinol and febuxostat treat gout by inhibiting the enzyme xanthine oxidase, which reduces the production of uric acid. Lowering uric acid levels helps prevent the formation of urate crystals that cause gout flares. Uricosuric agents increase uric acid excretion in the urine, further reducing blood uric acid levels. These mechanisms are vital for gout patients as they help prevent painful attacks and long-term joint damage.
Uric acid lowering for slowing CKD progression after the CKD-FIX trial: a solved question or still a dilemma?Gout: Rapid Evidence Review.The net clinical benefits of febuxostat versus allopurinol in patients with gout or asymptomatic hyperuricemia - A systematic review and meta-analysis.

Find a Location

Who is running the clinical trial?

LG ChemLead Sponsor
62 Previous Clinical Trials
30,091 Total Patients Enrolled
8 Trials studying Gout
331 Patients Enrolled for Gout
Jisoo Lee, MDStudy DirectorLG Chem
2 Previous Clinical Trials
12,542 Total Patients Enrolled

Media Library

Tigulixostat (XO Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05586958 — Phase 3
Gout Research Study Groups: Tigulixostat 100mg, Tigulixostat 200mg, Tigulixostat 300mg, Placebo
Gout Clinical Trial 2023: Tigulixostat Highlights & Side Effects. Trial Name: NCT05586958 — Phase 3
Tigulixostat (XO Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05586958 — Phase 3
~70 spots leftby Dec 2024
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