A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
NCT Number: NCT06501534
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Gout|Hyperuricemia
Interventions: DRUG: Febuxostat|DRUG: IBI128
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-19
Completion Date: 2025-02-05
Locations: Shanghai Fudan University HuaShan Hospital, Shanghai, Shanghai, 200040, China

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.

Primary Outcome Measures: The proportion of subjects in each treatment group with serum uric acid levels <360 μmol/L after continuous treatment for 16 weeks, Week 16
Secondary Outcome Measures: The proportion of subjects in each treatment group with serum uric acid levels <300 μmol/L after continuous treatment for 16 weeks, 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, 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, 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, Baseline through Week 16/18|Number of subjects with Adverse Event, Serious Adverse Events, Treatment Emergent Adverse Event, Adverse event of special interest, 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., 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., Baseline through Week 16/18|Number of subjects with clinically significant changes in clinical laboratory parameters, Clinical laboratory parameters including white blood cell, red blood cell, hemoglobin, platelet, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, serum creatinine, fasting serum glucose, toal bilirubin, direct bilirubin, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, serum potassium, creatine phosphokinase, hs-CRP, prothrombin time, thrombin time, activated partial thromboplastin time, international normalized ratio, Baseline through Week 16/18|Number of subjects with clinically significant changes in electrodiagram, Electrodiagram parameters including PRinterval, heart rate, RRinterval, corrected QT interval by Fridericia's formula, Baseline through Week 16/18|Plasma concentration of Tigulixostat, Baseline through Week 16/18