What side effects are associated with this type of intervention?

Common treatments for gout, such as Xanthine Oxidase Inhibitors (XOIs) like allopurinol and febuxostat, have several known side effects. Allopurinol can cause hypersensitivity reactions, including severe skin rashes, and requires dose adjustments in patients with renal impairment. Febuxostat has been associated with a higher risk of cardiovascular events, including cardiovascular death, particularly in patients with pre-existing cardiovascular conditions. Both medications can also lead to liver function abnormalities and gastrointestinal issues. These side effects necessitate careful consideration and monitoring when choosing the appropriate treatment for gout.

What prior FDA approvals exist?

The FDA has approved several xanthine oxidase inhibitors (XOIs) for the treatment of gout, including allopurinol and febuxostat. Allopurinol, a purine analog, has been widely used for many years to lower uric acid levels in patients with gout. Febuxostat, a non-purine selective inhibitor of xanthine oxidase, was approved more recently and offers an alternative for patients who cannot tolerate allopurinol. Both drugs work by inhibiting the enzyme xanthine oxidase, thereby reducing the production of uric acid. These treatments are similar to Tigulixostat, which is currently being studied in clinical trials for its efficacy and safety in gout patients with hyperuricemia.

What other types of research exist?

Promising novel alternatives to Tigulixostat for gout patients include Dotinurad, a selective urate reabsorption inhibitor, and Rilonacept, which has shown efficacy in reducing gout flares. Additionally, Pegloticase remains a viable option for patients who do not respond to conventional therapies.

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XO Inhibitor

Tigulixostat for Gout (EURELIA1 Trial)

Q: What is the mechanism of action of this treatment?

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.

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.

Must not have

Subjects with secondary hyperuricemia, enzymatic defects

Subjects who have received pegloticase to treat gout which has not responded to the usual treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Awards & highlights

Pivotal Trial

Summary

This trial is testing Tigulixostat, a medication that may help people with gout by lowering high uric acid levels. The study focuses on gout patients who have too much uric acid in their blood. By reducing uric acid, Tigulixostat aims to prevent or lessen painful gout attacks.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have high uric acid levels and gout according to ACR/EULAR 2015.

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My uric acid levels are high, even with or without gout medication.

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My BMI is 50 or less and my kidney function is good.

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I have high uric acid levels and gout according to ACR/EULAR 2015.

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My uric acid levels are high despite taking or not taking urate-lowering medication.

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My BMI is 50 or less and my kidney function is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high uric acid levels due to an enzyme problem.

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I have taken pegloticase for gout that didn't improve with standard treatments.

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I have a history of high xanthine in my urine and rheumatoid arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

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

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

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

Awards & Highlights

Pivotal Trial

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

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

0 / 9Eligibility criteria met

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.