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

Innovent Biologics (Suzhou) Co. Ltd.84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gout Hyperuricemia

Interventions

FebuxostatDRUG

Tablets, Once a day (QD), Per oral

IBI128DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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

Time frame: Week 16

Secondary Outcomes

The proportion of subjects in each treatment group with serum uric acid levels <300 μmol/L after continuous treatment for 16 weeks

Time frame: Week 16

The proportion of subjects in each treatment group with serum uric acid levels <360, <300 μmol/L after continuous treatment for 2, 4, 8, 12 weeks

Time frame: Week 2, 4, 8, 12

Absolute and percentage Changes in serum uric acid levels from baseline in subjects of each treatment group after continuous treatment for 2, 4, 8, 12, and 16 weeks

Time frame: Baseline, Week 2, 4, 8, 12

The proportion of subjects experiencing gout flares and the number of gout flare occurrences within every 4 weeks from the first dose, among those receiving various doses of Tigulixostat tablets and Febuxostat tablets

Time frame: Baseline through Week 16/18

Number of subjects with Adverse Event, Serious Adverse Events, Treatment Emergent Adverse Event, Adverse event of special interest

Time frame: Baseline through Week 18/20

Number of subjects with clinically significant changes in physical examination results

Clinically significant abnormal physical examination findings reported by the investigator.

Time frame: Baseline through Week 16/18

Number of subjects with clinically significant changes in in vital sign

Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure.

Data from ClinicalTrials.gov

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