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A study to assess the efficacy and safety of tigulixostat at different doses as compared to a control drug (allopurinol) in gout patients with hyperuricemia
EU CTIS ID: 2022-501421-20-00
What this study is testing
To compare the efficacy of tigulixostat to appropriately titrated allopurinol (up to 800 mg/day) in achieving sUA levels of <6 mg/dL at Months 4, 5, and 6.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject or the subject’s legally acceptable representative is willing and able to provide written ICF prior to the initiation of any study procedures.
- Male or female subjects between the ages of 18 and 85 years, inclusive.
- Subjects with hyperuricemia and a history or presence of gout per ACR/EULAR 2015 criteria (Neogi et al 2015).
- Subjects who are currently on 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 a sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
- Subjects with a BMI ≤50 kg/m2 at screening (Visit 1).
- Subjects with eGFR ≥30 mL/min/1.73m2 at screening (Visit 1).
You likely can't join if
- Subjects with secondary hyperuricemia (e.g., due to myeloproliferative disorder or their treatment, organ transplant, therapeutic regimens that produce hyperuricemia, renal failure, renal tubular disorders, lead poisoning, hyperproliferative skin disorders, enzymatic defects (eg, deficient hypoxanthine-guanine phosphoribosyl transferase, glycogen storage diseases)).
- Subjects experiencing an active acute gout attack within 2 weeks prior to screening (Visit 1).
- Subjects who are Asian descent (eg, Han Chinese, Korean, Thai) and Black/African descent (eg. African American) with a positive test for HLA B*58:01.
- Subjects who have received uricase (e.g., pegloticase).
- Subjects who have not been receiving stable doses of drugs known to affect sUA levels (losartan, fibrates, thiazide diuretics, loop diuretics, ASA) for the last 3 weeks prior to screening (Visit 1). Acetylsalicylic acid use more than 325 mg/day is not allowed.
- Subjects with a history of xanthinuria.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Colombia
- Georgia
- Brazil
- New Zealand
- Korea, Republic of
- Thailand
- Taiwan
- Philippines
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Colombia; Georgia; Brazil; New Zealand and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.