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

NCT ID: NCT06501534

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-01-09

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 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.

Conditions

Gout; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Febuxostat 40mg

Tablets, Once a day (QD), Per oral

Group Type: ACTIVE_COMPARATOR

Febuxostat

Intervention Type: DRUG

Tablets, Once a day (QD), Per oral

IBI128 50mg

Tablets, Once a day (QD), Per oral

Group Type: EXPERIMENTAL

IBI128

Intervention Type: DRUG

Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral

IBI128 200mg

Tablets, Once a day (QD), Per oral

Group Type: EXPERIMENTAL

IBI128

Intervention Type: DRUG

Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral

IBI128 100mg

Tablets, Once a day (QD), Per oral

Group Type: EXPERIMENTAL

IBI128

Intervention Type: DRUG

Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral

Interventions

Febuxostat

Tablets, Once a day (QD), Per oral

Intervention Type: DRUG

IBI128

Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CIBI128A201

Identifier Type: -

Identifier Source: org_study_id