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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
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
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
10,542 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken pegloticase for gout that didn't improve with standard treatments.I am between 18 and 85 years old.I have had a severe gout attack in the last 2 weeks.My uric acid levels are high despite taking or not taking urate-lowering medication.My uric acid levels are high, even with or without gout medication.I have high uric acid levels and gout according to ACR/EULAR 2015.My BMI is 50 or less and my kidney function is adequate.I haven't taken drugs that change uric acid levels in the last 3 weeks.I have a history of high xanthine in my urine and rheumatoid arthritis.I am between 18 and 85 years old.I have high uric acid levels and gout according to ACR/EULAR 2015.I have high uric acid levels due to an enzyme problem.My BMI is 50 or less and my kidney function is good.
Research Study Groups:
This trial has the following groups:- Group 1: Tigulixostat 100mg
- Group 2: Tigulixostat 200mg
- Group 3: Tigulixostat 300mg
- Group 4: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experimental process extend to octogenarians?
"This study is accepting individuals who are 18 years and older, but must be younger than 85."
Answered by AI
Has Tigulixostat 200mg been given the green light by the FDA?
"Our experts at Power rate the safety of Tigulixostat 200mg a 3, as this Phase 3 trial has generated compelling evidence in support of its efficacy and repeated documentation attesting to its safety."
Answered by AI
What is the current enrollment figure for this research trial?
"Indeed, according to clinicaltrials.gov, this study is actively seeking participants. It was published on October 25th 2022 and last modified on January 10th 2023; the researchers are looking for 350 individuals from one specific location."
Answered by AI
Does this research project presently have room for additional participants?
"Affirmative. Clinicaltrials.gov supplies evidence that this clinical trial, having been posted on October 25th 2022, is currently in search of new participants. 350 people are wanted for the study at one medical centre."
Answered by AI
May I be accepted as a participant in this research endeavor?
"This scientific research is seeking 350 participants between 18 and 85 years of age who have had a diagnosis of hyperuricemia. Criteria for consideration includes meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria, having an sUA level ≥6.0 mg/dL at screening if currently on urate-lowering therapies or an sUA level ≥7.0 mg/dL at screening otherwise; BMI ≤50 kg/m2 and eGFR≥30mL//min1.73 m2; as well being within the specified age range for"
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Direct Helpers Research Center
Pioneer Research Solutions, Inc.
Other
Triad Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Clinical Research of West Florida: < 48 hours
Average response time
- < 2 Days
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