Status:
COMPLETED
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Gout
Hyperuricemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
IBI128 (Tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (XO). The XO inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid. This ia ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants must be aged between 18 and 75 years old (inclusive, as of the time of signing the informed consent form), with no gender restrictions;
- Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
- Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
- At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
- Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.
- Exclusion criteria (brief):
- History of allergy to any component of Tigulixostat;
- Previous allergy or intolerance to Febuxostat;
- Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;
- Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;
- Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);
- Subjects with a history of xanthinuria.
Exclusion
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06501534
Start Date
July 10 2024
End Date
January 9 2025
Last Update
March 27 2025
Active Locations (1)
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1
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, China, 200040