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

Innovent Biologics

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Gout

Treatments: Drug: IBI128; Drug: Febuxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06501534

CIBI128A201

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. 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;
2. Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
3. Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
4. At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
5. Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.

Exclusion criteria (brief):

1. History of allergy to any component of Tigulixostat;
2. Previous allergy or intolerance to Febuxostat;
3. Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;
4. Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;
5. Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);
6. Subjects with a history of xanthinuria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 4 patient groups

Febuxostat 40mg

Active Comparator group

Description:

Tablets, Once a day (QD), Per oral

Treatment:

Drug: Febuxostat

IBI128 50mg

Experimental group

Description:

Tablets, Once a day (QD), Per oral

Treatment:

Drug: IBI128

IBI128 200mg

Experimental group

Description:

Tablets, Once a day (QD), Per oral

Treatment:

Drug: IBI128

IBI128 100mg

Experimental group

Description:

Tablets, Once a day (QD), Per oral

Treatment:

Drug: IBI128