Tigulixostat 200mg for High Uric Acid

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
High Uric Acid+3 MoreTigulixostat - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

Study Summary

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Eligible Conditions
  • Gouty Tophi
  • High Uric Acid
  • Gout Flare
  • Gout

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to Month 6

Up to Month 6
Incidence rate of adverse event
The proportion of subjects reporting a gout flare up to each visit.
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Tigulixostat 200mg
1 of 4
Tigulixostat 300mg
1 of 4
Tigulixostat 100mg
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

350 Total Participants · 4 Treatment Groups

Primary Treatment: Tigulixostat 200mg · Has Placebo Group · Phase 3

Tigulixostat 200mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Tigulixostat 300mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Tigulixostat 100mg
Drug
Experimental Group · 1 Intervention: Tigulixostat · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to month 6

Who is running the clinical trial?

LG ChemLead Sponsor
55 Previous Clinical Trials
30,134 Total Patients Enrolled
Jisoo Lee, MDStudy DirectorLG Chem
2 Previous Clinical Trials
10,542 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.
You are male or female, between the ages of 18 and 85 years, inclusive.