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Compares treatment options for Gout
Official title Tigulixostat (IBI128) vs Febuxostat in Gout
ClinicalTrials.gov ID: NCT07414394
What this study is testing
What is Febuxostat?
Febuxostat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gout.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level \< 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all of the following criteria to be eligible for the study:
- Age ≥ 18 years, male or female.
- Body mass index (BMI) between 18 and 40 kg/m².
- Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.
- Serum uric acid (sUA) at screening: ≥ 480 μmol/L for people without comorbidities; ≥ 420 μmol/L for people with at least one concurrent condition...
You likely can't join if
- Participants who meet any of the following criteria will be excluded from the study:
- History of allergy or intolerance to any component of febuxostat or Tigulixostat, or previous evidence of poor response to febuxostat treatment...
- Acute gout attack within 4 weeks prior to screening or from screening to first dose.
- Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium...
- Hyperuricemia caused by secondary gout (e.g., myeloproliferative disease, tumor, organ transplantation, enzyme deficiency, renal tubular dysfunction...
- Use of the following medications or therapies prior to screening or planned during the study: (1)Prior urate oxidase treatment; (2)Concomitant...
See the full eligibility criteria
- Participants must meet all of the following criteria to be eligible for the study:
- Age ≥ 18 years, male or female.
- Body mass index (BMI) between 18 and 40 kg/m².
- Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.
- Serum uric acid (sUA) at screening: ≥ 480 μmol/L for people without comorbidities; ≥ 420 μmol/L for people with at least one concurrent condition (e.g., ≥ 2 gout attacks/year, tophi, chronic gouty arthritis...
- Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.
- Participants who meet any of the following criteria will be excluded from the study:
- History of allergy or intolerance to any component of febuxostat or Tigulixostat, or previous evidence of poor response to febuxostat treatment (e.g., sUA \> 420 μmol/L after ≥ 6 weeks of febuxostat ≥ 40 mg).
- Acute gout attack within 4 weeks prior to screening or from screening to first dose.
- Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium bicarbonate) within 2 weeks before screening.
- Hyperuricemia caused by secondary gout (e.g., myeloproliferative disease, tumor, organ transplantation, enzyme deficiency, renal tubular dysfunction, lead poisoning, psoriasis, medications), excluding hyperuricemia due...
- Use of the following medications or therapies prior to screening or planned during the study: (1)Prior urate oxidase treatment; (2)Concomitant medications affecting uric acid levels within 4 weeks before screening with...
- Xanthinuria, Lech-Nyhan syndrome, 5-phosphoribosyl-1-pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, rhabdomyolysis;
- Uncontrolled severe pain not caused by gout;
- Cardiovascular events or conditions within 6 months (e.g., acute MI, ACS, unstable angina, CABG, PCI, TIA, cerebrovascular accident, severe arrhythmia, NYHA class III/IV heart failure);
- QTcF ≥ 480 ms or history of prolonged QTc interval;
- Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) or recent adjustment of antihypertensive drugs;
- Poorly controlled diabetes (HbA1c ≥ 9.0%);
- Autoimmune or inflammatory diseases requiring systemic immunosuppressive treatment;
- Active peptic ulcer or GI bleeding within 1 month;
- Diseases affecting drug absorption (e.g., IBS, IBD);
- Active hepatitis B, C, HIV, or syphilis infection;
- Active or untreated malignancy within 5 years, except specified low-risk cancers;
- Thyroid dysfunction requiring treatment. 7. Laboratory abnormalities: (1)total bilirubin \> 2×ULN, ALT or AST \> 3×ULN; (2)eGFR \ 21 units for males, \> 14 units for females). 10\. Blood donation or loss ≥ 400 mL within...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.