CompletedPhase 2

A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects

China84 participantsStarted 2024-07-10

Plain-language 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 a randomized, open label, multicenter, parallel-group, positive-controlled, dose finding, and Phase II study to assess efficacy and safety of IBI128 in chinese gout subjects.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

✕. 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.

What they're measuring

The proportion of subjects in each treatment group with serum uric acid levels <360 μmol/L after continuous treatment for 16 weeks

Timeframe: Week 16

Trial details

NCT IDNCT06501534

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-13

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