Study Summary
This trial tests if a drug can help treat gout by decreasing uric acid levels in the body.
- Gout
- High Uric Acid
- Gout Flare
- Gouty Tophi
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: From Month 6 to Month 12
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
5 Treatment Groups
Titrated allopurinol (100-800mg)
1 of 5
Tigulixostat 200mg
1 of 5
Tigulixostat 100mg
1 of 5
Tigulixostat 300mg
1 of 5
Placebo
1 of 5
Active Control
Experimental Treatment
Non-Treatment Group
2542 Total Participants · 5 Treatment Groups
Primary Treatment: Tigulixostat 200mg · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 85 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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" - Anonymous Online Contributor