Tigulixostat (IBI128) vs Febuxostat in Gout

NCT07414394 | Recruiting Phase 3 DMC

• 1 other identifier: CIBI128A301
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Proportion of Participants Achieving Serum Uric Acid <360 μmol/L at Week 12

  At Week 12

• Proportion of Participants with Serum Uric Acid <360 μmol/L at Each Scheduled Visit

  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

  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

  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

  At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52

Study Arms (2)

Tigulixostat

EXPERIMENTAL

Drug: Tigulixostat

Febuxostat

ACTIVE COMPARATOR

Drug: Febuxostat

Interventions

Febuxostat DRUG

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.

Febuxostat

Tigulixostat DRUG

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.

Also known as: IBI128

Tigulixostat

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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:
• (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.
• \. 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;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Fudan University HuaShan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Gout

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Chunmiao Li

CONTACT

+8618321232774; chunmiao.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)