Clinical trial NCT06501534: A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. 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;
2. Body Mass Index (BMI) should fall within the range of 18.0 to 40.0 kg/m² (including both ends of the range);
3. Subjects must meet the 2015 ACR/EULAR classification criteria for the diagnosis of gout (refer to Appendix 4);
4. At the screening stage, subjects must have a blood uric acid level of ≥480 μmol/L;
5. Subjects must voluntarily sign the informed consent form and agree to strictly adhere to the requirements outlined in this protocol.

Exclusion criteria (brief):

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

Primary outcomes:
measure: The proportion of subjects in each treatment group with serum uric acid levels <360 μmol/L after continuous treatment for 16 weeks
timeFrame: Week 16
Secondary outcomes:
measure: The proportion of subjects in each treatment group with serum uric acid levels <300 μmol/L after continuous treatment for 16 weeks
timeFrame: Week 16
measure: 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
timeFrame: Week 2, 4, 8, 12
measure: 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
timeFrame: Baseline, Week 2, 4, 8, 12
measure: 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
timeFrame: Baseline through Week 16/18
measure: Number of subjects with Adverse Event, Serious Adverse Events, Treatment Emergent Adverse Event, Adverse event of special interest
timeFrame: Baseline through Week 18/20
measure: Number of subjects with clinically significant changes in physical examination results
timeFrame: Baseline through Week 16/18
measure: Number of subjects with clinically significant changes in in vital sign
timeFrame: Baseline through Week 16/18
measure: Number of subjects with clinically significant changes in clinical laboratory parameters
timeFrame: Baseline through Week 16/18
measure: Number of subjects with clinically significant changes in electrodiagram
timeFrame: Baseline through Week 16/18
measure: Plasma concentration of Tigulixostat
timeFrame: Baseline through Week 16/18
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fudan University HuaShan Hospital
state: Shanghai
Study officials:
References: