GoutPhase 2NCT06501534
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
A Phase 2 study testing Febuxostat and IBI128 in people with Gout and Hyperuricemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Febuxostat and IBI128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 9 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, 200040
About this study
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
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
- Being tested
- Febuxostat, IBI128
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
Tablets, Once a day (QD), Per oral
IBI128Drug
Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral
| Study group | Role | What they receive |
|---|---|---|
| Febuxostat 40mg | Active comparator | Tablets, Once a day (QD), Per oral Receives: Drug: Febuxostat |
| IBI128 50mg | Experimental | Tablets, Once a day (QD), Per oral Receives: Drug: IBI128 |
| IBI128 200mg | Experimental | Tablets, Once a day (QD), Per oral Receives: Drug: IBI128 |
| IBI128 100mg | Experimental | Tablets, Once a day (QD), Per oral Receives: Drug: IBI128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in each treatment group with serum uric acid levels <360 μmol/L after continuous treatment for 16 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline through Week 16/18
Number of subjects with Adverse Event, Serious Adverse Events, Treatment Emergent Adverse Event, Adverse event of special interest
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Baseline through Week 16/18
Plasma concentration of Tigulixostat
Measured: Baseline through Week 16/18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start10 Jul 2024
- Primary completion13 Dec 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501534
- Sponsor's protocol ID
- CIBI128A201
- Status last verified
- Mar 2025
- First submitted
- 2 Jul 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06501534
- Acronym / sponsor ID
- CIBI128A201
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Febuxostat 40mg | Active comparator | Drug: FebuxostatTablets, Once a day (QD), Per oral |
| IBI128 50mg | Experimental | Drug: IBI128Tablets, Once a day (QD), Per oral |
| IBI128 200mg | Experimental | Drug: IBI128Tablets, Once a day (QD), Per oral |
| IBI128 100mg | Experimental | Drug: IBI128Tablets, Once a day (QD), Per oral |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FebuxostatTablets, Once a day (QD), Per oral | Drug | Febuxostat 40mg |
| IBI128Other Names: LC350189, Tigulixostat,Tablets, Once a day (QD), Per oral | Drug | IBI128 100mg, IBI128 200mg, IBI128 50mg |
Primary outcome
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
10 secondary outcomes
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
Time frame: Baseline through Week 16/18
Number of subjects with clinically significant changes in in vital sign
Time frame: Baseline through Week 16/18
Number of subjects with clinically significant changes in clinical laboratory parameters
Time frame: Baseline through Week 16/18
Number of subjects with clinically significant changes in electrodiagram
Time frame: Baseline through Week 16/18
Plasma concentration of Tigulixostat
Time frame: Baseline through Week 16/18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Febuxostat and IBI128 in people with Gout and Hyperuricemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.