A Phase 2 interventional study of Febuxostat and IBI128 in Gout and Hyperuricemia, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 2, Interventional, and Treatment
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.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's enrollment of 84 is below the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria (brief):
Tablets, Once a day (QD), Per oral
Drug: Febuxostat
Tablets, Once a day (QD), Per oral
Drug: IBI128
Tablets, Once a day (QD), Per oral
Drug: IBI128
Tablets, Once a day (QD), Per oral
Drug: IBI128
Tablets, Once a day (QD), Per oral
Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral
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
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.
Time frame: 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
Time frame: 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
Time frame: Baseline through Week 16/18
Plasma concentration of Tigulixostat
Time frame: Baseline through Week 16/18
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Innovent Biologics (Suzhou) Co. Ltd.