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NCT Number: NCT06501534

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

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, 200040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
  • Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
  • At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
  • Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.

Exclusion criteria

(brief):

  • History of allergy to any component of Tigulixostat;
  • Previous allergy or intolerance to Febuxostat;
  • Subjects who have taken uric acid lowering medications within 2 weeks prior to screening;
  • Subjects who experienced an acute gout flare-up within 4 weeks prior to screening or immediately before the first dose administration;
  • Subjects considered to have secondary gout (elevated serum uric acid due to causes other than renal insufficiency);
  • Subjects with a history of xanthinuria.

Treatment and study plan

Febuxostat

Drug

Tablets, Once a day (QD), Per oral

IBI128

Drug

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Number of subjects with clinically significant changes in physical examination results

    Time frame: Baseline through Week 16/18

    Clinically significant abnormal physical examination findings reported by the investigator.

  7. Number of subjects with clinically significant changes in in vital sign

    Time frame: Baseline through Week 16/18

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

  8. Number of subjects with clinically significant changes in clinical laboratory parameters

    Time frame: 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

  9. Number of subjects with clinically significant changes in electrodiagram

    Time frame: Baseline through Week 16/18

    Electrodiagram parameters including PRinterval, heart rate, RRinterval, corrected QT interval by Fridericia's formula

  10. Plasma concentration of Tigulixostat

    Time frame: Baseline through Week 16/18

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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