Health TrialsbyHealthPanel

Tigulixostat (IBI128) vs Febuxostat in Gout

ConditionGout
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovent Biologics Technology Limited (Shanghai R&D Center)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: TigulixostatExperimental treatment 1 intervention
Group B: FebuxostatActive comparator 1 intervention

Trial outcomes

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.

Time frame
At Week 24

Secondary outcomes

1

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.

Time frame
At Week 12
2

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.

Time frame
At Week 0, 2, 4, 8, 12, 16, 20, 24, 32, 42, and 52
3

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.

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

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Innovent Biologics Technology Limited (Shanghai R&D Center)

Lead sponsor

Source ClinicalTrials.gov
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