Tigulixostat (IBI128) vs Febuxostat in Gout

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.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: Tigulixostat; Drug: Febuxostat

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chunmiao Li; Phone Number: +8618321232774; Email: chunmiao.li@innoventbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Shanghai Fudan University HuaShan Hospital
      • Contact: Hejian Zou; Phone Number: +8613311881366; Email: hjzou@unirheuma.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for the study:

1. Age ≥ 18 years, male or female.
2. Body mass index (BMI) between 18 and 40 kg/m².
3. Diagnosed with gout according to the 2015 ACR/EULAR classification criteria.

4. 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).

5. Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from the study:

1. 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).
2. Acute gout attack within 4 weeks prior to screening or from screening to first dose.
3. Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium bicarbonate) within 2 weeks before screening.
4. 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.
5. Use of the following medications or therapies prior to screening or planned during the study:

(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:

1. Xanthinuria, Lech-Nyhan syndrome, 5-phosphoribosyl-1-pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, rhabdomyolysis;
2. Uncontrolled severe pain not caused by gout;
3. 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);
4. QTcF ≥ 480 ms or history of prolonged QTc interval;
5. Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) or recent adjustment of antihypertensive drugs;
6. Poorly controlled diabetes (HbA1c ≥ 9.0%);
7. Autoimmune or inflammatory diseases requiring systemic immunosuppressive treatment;
8. Active peptic ulcer or GI bleeding within 1 month;
9. Diseases affecting drug absorption (e.g., IBS, IBD);
10. Active hepatitis B, C, HIV, or syphilis infection;
11. Active or untreated malignancy within 5 years, except specified low-risk cancers;
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Febuxostat	Drug: Febuxostat; 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.
Experimental: Tigulixostat	Drug: Tigulixostat; 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.; Other Names: IBI128

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	At Weeks 12, 24, and 52

Collaborators and Investigators

• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Gout; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Febuxostat
• Other Study ID Numbers: CIBI128A301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No