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

NCT06501534 | Completed Phase 2

• 1 other identifier: CIBI128A201
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout; Hyperuricemia

Outcome Measures

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

  Week 16

Secondary Outcomes (10)

• 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

Study Arms (4)

Febuxostat 40mg

ACTIVE COMPARATOR

Tablets, Once a day (QD), Per oral

Drug: Febuxostat

IBI128 50mg

EXPERIMENTAL

Tablets, Once a day (QD), Per oral

Drug: IBI128

IBI128 200mg

EXPERIMENTAL

Tablets, Once a day (QD), Per oral

Drug: IBI128

IBI128 100mg

EXPERIMENTAL

Tablets, Once a day (QD), Per oral

Drug: IBI128

Interventions

Febuxostat DRUG

Tablets, Once a day (QD), Per oral

Febuxostat 40mg

IBI128 DRUG

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

IBI128 100mg; IBI128 200mg; IBI128 50mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 15, 2024
• Study Start: July 10, 2024
• Primary Completion: December 13, 2024
• Study Completion: January 9, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)