Tigulixostat (IBI128) vs Febuxostat in Gout
ConditionGout
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics Technology Limited (Shanghai R&D Center)
About this trial
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. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.
Eligibility criteria
Qualifiers
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.
Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.
Disqualifiers
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 to renal insufficiency.
Trial design
Treatments tested in this trial
- Febuxostat
- Tigulixostat
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov