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

Phase 2

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: Febuxostat; Drug: IBI128

• Registration Number: NCT06501534
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-09
• Study Start: 2024-07-10
• Study First Posted: 2024-07-15
• Primary Completion: 2024-12-13
• Study Completion: 2025-01-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat 40mg	Febuxostat	Tablets, Once a day (QD), Per oral
IBI128 50mg	IBI128	Tablets, Once a day (QD), Per oral
IBI128 200mg	IBI128	Tablets, Once a day (QD), Per oral
IBI128 100mg	IBI128	Tablets, Once a day (QD), Per oral

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The proportion of subjects in each treatment group with serum uric acid levels <300 μmol/L after continuous treatment for 16 weeks	Week 16
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
Number of subjects with clinically significant changes in physical examination results	Baseline through Week 16/18	Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in in vital sign	Baseline through Week 16/18	Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure.
Number of subjects with clinically significant changes in clinical laboratory parameters	Baseline through Week 16/18	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
Number of subjects with clinically significant changes in electrodiagram	Baseline through Week 16/18	Electrodiagram parameters including PRinterval, heart rate, RRinterval, corrected QT interval by Fridericia's formula
Plasma concentration of Tigulixostat	Baseline through Week 16/18
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
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

Trial Locations

Locations (1)

Shanghai Fudan University HuaShan Hospital; 🇨🇳 Shanghai, Shanghai, China