GoutPhase 3NCT07414394

Tigulixostat (IBI128) vs Febuxostat in Gout

A Phase 3 study testing Febuxostat and Tigulixostat in people with Gout, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gout
What is being tested?: Febuxostat and Tigulixostat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteChina
Study dates: 17 Mar 2026to 30 Oct 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be eligible for the study:
Age ≥ 18 years, male or female.
Body mass index (BMI) between 18 and 40 kg/m².
Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.
Serum uric acid (sUA) at screening:
≥ 480 μmol/L for subjects without comorbidities;
≥ 420 μmol/L for subjects with at least one concurrent condition (e.g., ≥ 2 gout attacks/year, tophi, chronic gouty arthritis, hypertension, diabetes, dyslipidemia, age of onset < 40 years).
Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.

Who cannot join

Participants who meet any of the following criteria will be excluded from the study:
History of allergy or intolerance to any component of febuxostat or Tigulixostat, or previous evidence of poor response to febuxostat treatment (e.g., sUA > 420 μmol/L after ≥ 6 weeks of febuxostat ≥ 40 mg).
Acute gout attack within 4 weeks prior to screening or from screening to first dose.
Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium bicarbonate) within 2 weeks before screening.
Hyperuricemia caused by secondary gout (e.g., myeloproliferative disease, tumor, organ transplantation, enzyme deficiency, renal tubular dysfunction, lead poisoning, psoriasis, medications), excluding hyperuricemia due to renal insufficiency.
Use of the following medications or therapies prior to screening or planned during the study:

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(1)Prior urate oxidase treatment; (2)Concomitant medications affecting uric acid levels within 4 weeks before screening with dose adjustments (e.g., losartan, calcium channel blockers, diuretics, fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4 inhibitors, SGLT2 inhibitors, metformin, GLP-1 receptor agonists, pyrazinamide, aspirin); (3)Long-term drugs dependent on xanthine oxidase metabolism (e.g., azathioprine, mercaptopurine); (4)Oral corticosteroids ≥ 10 consecutive days, or intramuscular/intravenous/intra-articular corticosteroid injection within 4 weeks before screening; (5)Biologics (e.g., TNF-α inhibitors, IL-1 inhibitors, IL-6 inhibitors) within 12 weeks before screening.
6. History or evidence of any of the following diseases:
Xanthinuria, Lech-Nyhan syndrome, 5-phosphoribosyl-1-pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, rhabdomyolysis;
Uncontrolled severe pain not caused by gout;
Cardiovascular events or conditions within 6 months (e.g., acute MI, ACS, unstable angina, CABG, PCI, TIA, cerebrovascular accident, severe arrhythmia, NYHA class III/IV heart failure);
QTcF ≥ 480 ms or history of prolonged QTc interval;
Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) or recent adjustment of antihypertensive drugs;
Poorly controlled diabetes (HbA1c ≥ 9.0%);
Autoimmune or inflammatory diseases requiring systemic immunosuppressive treatment;
Active peptic ulcer or GI bleeding within 1 month;
Diseases affecting drug absorption (e.g., IBS, IBD);
Active hepatitis B, C, HIV, or syphilis infection;
Active or untreated malignancy within 5 years, except specified low-risk cancers;
Thyroid dysfunction requiring treatment. 7. Laboratory abnormalities:
(1)total bilirubin > 2×ULN, ALT or AST > 3×ULN; (2)eGFR < 30 mL/min/1.73 m². 8. Pregnant or lactating women, or participants unwilling to use effective contraception during the study and for 8 weeks after study end.
9. History of alcohol or drug abuse (weekly alcohol > 21 units for males, > 14 units for females).
10. Blood donation or loss ≥ 400 mL within 3 months, or prior blood transfusion.
11. Participation in another interventional clinical trial within 3 months or 5 half-lives of prior investigational drug.
12. Major surgery within 3 months, incomplete recovery, or planned major surgery during study.
13. Presence of mental illness deemed inappropriate for study participation by the investigator.
14. Any other condition judged by the investigator to potentially affect study efficacy or safety evaluation.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout

The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level < 360 μmol/L at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.

Conditions: Gout
Being tested: Febuxostat, Tigulixostat
Medical subject headings: Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FebuxostatDrug
Participants in this group receive Febuxostat tablets together with dummy tablets matching Tigulixostat once daily during the 24-week core treatment period. Thereafter, participants switch to Tigulixostat tablets alone once daily during the 28-week extension treatment period.
TigulixostatDrug
Also called IBI128
Participants in this group receive Tigulixostat (IBI128) tablets together with dummy tablets matching Febuxostat once daily during the 24-week core treatment period, with dose escalation per protocol. Thereafter, participants continue Tigulixostat tablets alone once daily during the 28-week extension treatment period.

Study groups in NCT07414394
Study group	Role	What they receive
Tigulixostat	Experimental	Not described Receives: Drug: Tigulixostat
Febuxostat	Active comparator	Not described Receives: Drug: Febuxostat

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 24
Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 24 after randomized treatment with Tigulixostat (IBI128) or Febuxostat in Chinese participants with gout.
Measured: At Week 24

Secondary outcomes (11)

Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 12
Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 12.
Measured: At Week 12
Proportion of Participants with Serum Uric Acid <360 μmol/L at Each Scheduled Visit
Proportion of participants achieving a serum uric acid (sUA) level <360 μmol/L at each scheduled visit during the 52-week study period.
Measured: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Proportion of Participants Achieving Serum Uric Acid <300 μmol/L at Each Scheduled Visit
Percentage of participants with serum uric acid (sUA) level below 300 μmol/L at each scheduled visit during the 52-week treatment period.
Measured: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Proportion of Participants Achieving Serum Uric Acid <240 μmol/L at Each Scheduled Visit
Percentage of participants with serum uric acid (sUA) level below 240 μmol/L at each scheduled visit during the 52-week treatment period.
Measured: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Mean Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit
Mean change from baseline in serum uric acid (sUA) level at each scheduled visit during the 52-week treatment period.
Measured: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Mean Percent Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit
Mean percent change from baseline in serum uric acid (sUA) level at each scheduled visit the 52-week treatment period.
Measured: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Number of Participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Percentage of participants who have experienced AEs/SAEs.
Measured: Baseline through Week 54 (end of safety follow-up)
Proportion and Number of Gout Flares per Participant
Proportion of participants experiencing gout flares and the number of gout flares per participant during each 4-week interval following initiation of study treatment.
Measured: Every 4 weeks from first dose through Week 52
Change From Baseline in Renal Function Parameters
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 12, 24, and 52.
Measured: At Week 12, 24, and 52
Change From Baseline in Renal Function Parameters
Change from baseline in urine albumin-to-creatinine ratio (UACR) at Weeks 12, 24, and 52.
Measured: At Weeks 12, 24, and 52
Change From Baseline in Inflammatory and Deposition-Related Parameters
Change from baseline in urolithiasis status, gouty tophi, and systemic inflammation as assessed by high-sensitivity C-reactive protein (hs-CRP) at Weeks 12, 24, and 52.
Measured: At Weeks 12, 24, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 202630 Oct 2027

First posted17 Feb 2026
Study start17 Mar 2026
Primary completion30 Apr 2027 (estimated)
Study completion30 Oct 2027 (estimated)

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07414394
Sponsor's protocol ID: CIBI128A301
Status last verified: Aug 2026
First submitted: 3 Feb 2026
Last updated: 1 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout
ClinicalTrials.gov ID: NCT07414394
Acronym / sponsor ID: CIBI128A301
Conditions: Gout
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 600 participants (actual)
Lead sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
Study start: 17 Mar 2026 (actual)
Primary completion: 30 Apr 2027 (estimated)
Study completion: 30 Oct 2027 (estimated)
First posted: 17 Feb 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tigulixostat	Experimental	Drug: Tigulixostat
Febuxostat	Active comparator	Drug: Febuxostat

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age ≥ 18 years, male or female.
Body mass index (BMI) between 18 and 40 kg/m².
Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.
Serum uric acid (sUA) at screening:
≥ 480 μmol/L for subjects without comorbidities;

Key exclusion criteria (27 listed)

History of allergy or intolerance to any component of febuxostat or Tigulixostat, or previous evidence of poor response to febuxostat treatment (e.g., sUA > 420 μmol/L after ≥ 6 weeks of febuxostat ≥ 40 mg).
Acute gout attack within 4 weeks prior to screening or from screening to first dose.
Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium bicarbonate) within 2 weeks before screening.
Hyperuricemia caused by secondary gout (e.g., myeloproliferative disease, tumor, organ transplantation, enzyme deficiency, renal tubular dysfunction, lead poisoning, psoriasis, medications), excluding hyperuricemia due to renal insufficiency.
Use of the following medications or therapies prior to screening or planned during the study:

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
FebuxostatParticipants in this group receive Febuxostat tablets together with dummy tablets matching Tigulixostat once daily during the 24-week core treatment period. Thereafter, participants switch to Tigulixostat tablets alone once daily during the 28-week extension treatment period.	Drug	Febuxostat
TigulixostatAlso: IBI128Participants in this group receive Tigulixostat (IBI128) tablets together with dummy tablets matching Febuxostat once daily during the 24-week core treatment period, with dose escalation per protocol. Thereafter, participants continue Tigulixostat tablets alone once daily during the 28-week extension treatment period.	Drug	Tigulixostat

Primary outcome

Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 24
Time frame: At Week 24
Percentage of participants with serum uric acid (sUA) level below 360 μmol/L at Week 24 after randomized treatment with Tigulixostat (IBI128) or Febuxostat in Chinese participants with gout.

11 secondary outcomes

Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 12
Time frame: At Week 12
Proportion of Participants with Serum Uric Acid <360 μmol/L at Each Scheduled Visit
Time frame: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Proportion of Participants Achieving Serum Uric Acid <300 μmol/L at Each Scheduled Visit
Time frame: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Proportion of Participants Achieving Serum Uric Acid <240 μmol/L at Each Scheduled Visit
Time frame: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Mean Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit
Time frame: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Mean Percent Change From Baseline in Serum Uric Acid Level at Each Scheduled Visit
Time frame: At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
Number of Participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Baseline through Week 54 (end of safety follow-up)
Proportion and Number of Gout Flares per Participant
Time frame: Every 4 weeks from first dose through Week 52
Change From Baseline in Renal Function Parameters
Time frame: At Week 12, 24, and 52
Change From Baseline in Renal Function Parameters
Time frame: At Weeks 12, 24, and 52
Change From Baseline in Inflammatory and Deposition-Related Parameters
Time frame: At Weeks 12, 24, and 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.

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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 3 study testing Febuxostat and Tigulixostat in people with Gout, run by Innovent Biologics Technology Limited (Shanghai R&D Center) 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 8 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07414394.

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 1 Sep 2026.