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Tigulixostat (IBI128) vs Febuxostat in Gout

NCT07414394 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2027-04-30
Completion
2027-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07414394 on ClinicalTrials.gov