Actively Recruiting
Tigulixostat (IBI128) vs Febuxostat in Gout
Led by Innovent Biologics Technology Limited (Shanghai R&D Center) · Updated on 2026-03-25
600
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tigulixostat (IBI128) vs Febuxostat in Gout
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, 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 at screening of at least 480 micromol/L for subjects without other conditions
- Serum uric acid at screening of at least 420 micromol/L for subjects with at least one concurrent condition such as 2 or more gout attacks per year, tophi, chronic gouty arthritis, hypertension, diabetes, dyslipidemia, or age of onset under 40 years
- Willing to sign informed consent and follow study requirements
You will not qualify if you...
- Allergy or intolerance to febuxostat or Tigulixostat, or poor response to febuxostat treatment
- Acute gout attack within 4 weeks before screening or from screening to first dose
- Use of uric acid-lowering drugs within 2 weeks before screening
- Secondary gout causes such as myeloproliferative disease, tumors, organ transplantation, enzyme deficiency, or medications, excluding renal insufficiency
- Use of certain medications affecting uric acid or immune treatments within specified timeframes before screening
- History or evidence of specific diseases including xanthinuria, uncontrolled severe pain, recent cardiovascular events, prolonged QTc interval, poorly controlled hypertension or diabetes, autoimmune diseases needing immunosuppressants, recent peptic ulcer or GI bleeding, active infections, recent malignancy except low-risk cancers, thyroid dysfunction requiring treatment
- Laboratory abnormalities including high bilirubin, liver enzymes, or low kidney function
- Pregnant or lactating women or those unwilling to use contraception during and 8 weeks after the study
- History of alcohol or drug abuse beyond set limits
- Recent blood donation or transfusion
- Participation in another clinical trial recently
- Major surgery within 3 months or planned surgery during study
- Mental illness judged unsuitable for participation
- Any other condition affecting safety or study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Fudan University HuaShan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
C
Chunmiao Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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