Your session is about to expire
← 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 weeks
Treatment 12 months
Follow Up 2 weeks
Awards & highlights
EURELIA2 Trial Summary
This trial tests if a drug can help treat gout by decreasing uric acid levels in the body.
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.Check my eligibility
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.See study design
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.
EURELIA2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion 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.
EURELIA2 Trial Timeline
Screening ~ 1 weeks0 visits
Treatment ~ 12 months13 visits
Follow Up ~ 2 weeks0 visits
Screening ~ 1 weeks
Treatment ~ 12 months
Follow Up ~2 weeks
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
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 moreSide effects data
From 2019 Phase 3 trial • 530 Patients • NCT0201717116%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Urinary tract infection
6%
Influenza like illness
6%
Sinusitis
6%
Diabetic ketoacidosis
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Osteomyelitis
2%
Abortion spontaneous
1%
Diarrhoea
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Chest pain
1%
Pancreatitis acute
1%
Asthma
1%
Coronary artery disease
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Cardiac arrest
1%
Hyperglycaemia
1%
Death
1%
Cellulitis
1%
Staphylococcal infection
1%
Road traffic accident
1%
Renal failure acute
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Hyperemesis gravidarum
1%
Angina unstable
1%
Impaired gastric emptying
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo
EURELIA2 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
62 Previous Clinical Trials
27,899 Total Patients Enrolled
Jisoo Lee, MDStudy DirectorLG Chem
2 Previous Clinical Trials
8,350 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My uric acid levels are high despite taking or not taking gout medication.I have high uric acid levels and gout according to ACR/EULAR 2015.My uric acid levels are high despite taking or not taking urate-lowering medications.I do not have uncontrolled pain unrelated to gout.I have not taken oral steroids in the past 2 weeks.I am between 18 and 85 years old.My BMI is 50 or less and my kidney function is good.I am between 18 and 85 years old.I have high uric acid levels and gout according to ACR/EULAR 2015.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: Titrated allopurinol (100-800mg)
- Group 5: 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 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks 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.
What is the cap on the number of participants in this experiment?
"The study necessitates the involvement of 2542 individuals who comply with its inclusion criteria. Patients can join from either Alliance for Multispecialty Research, LLC in Daphne, Arizona or Syed Research Consultants, LLC in Muscle Shoals, California."
Answered by AI
What safety considerations should be taken into account when administering Tigulixostat 200mg?
"Tigulixostat 200mg has been evaluated as 3 on a scale of 1 to 3 due to the established evidence from its Phase 3 trial demonstrating efficacy and safety."
Answered by AI
Does this research permit individuals aged 35 and above to take part?
"The age range for potential participants in this clinical trial are those who have reached the legal age of consent and are below 85 years old."
Answered by AI
Are there currently vacancies for individuals to participate in this research?
"Affirmative. According to clinicaltrials.gov, the trial launched on March 30th 2023 and was adjusted as recently as May 22nd 2023 is presently searching for participants. In total, 74 sites will be admitting 2542 patients into this investigation."
Answered by AI
How widely geographically dispersed is this scientific investigation in the USA?
"The study is accessible in 74 distinct clinical sites, including Alliance for Multispecialty Research, LLC (Daphne), Syed Research Consultants, LLC (Muscle Shoals) and Arizona Research Clinic PLLC (Sheffield)."
Answered by AI
How can I register for this research project?
"This clinical trial seeks 2,542 individuals aged between 18-85 suffering from gout. In addition to this qualification, participants must be either male or female; possess hyperuricemia and meet the ACR/EULAR 2015 criteria for gout; have a Body Mass Index ≤50 kg/m2 and an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1); those currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening should also undergo washout in order"
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Alliance for Multispecialty Research, LLC
New Phase Research
Clinical Trials Management - Northshore
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I need money. Keep getting gout and meds not stopping it from recurring. Aid in any clinical trials that will be conducted and aid others.
PatientReceived 1 prior treatment
I tried of the pain and hoping for a cure or some kind of relief. Money yes and to help people that have gout like me to take medicine.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Clinical Trials Management - Northshore: < 24 hours
- Clinical Trials Management - Southshore: < 24 hours
- Clinical Research of West Florida: < 48 hours
Average response time
- < 2 Days
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger