Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Description

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.

Conditions

Gout, Hyperuricemia, Gout Flare, Tophi

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Study Overview

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Study Details

Study overview

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.

A Randomized, Multi-regional, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study to Assess the Safety and Efficacy of 6 Months Treatment With Tigulixostat in Gout Patients With Hyperuricemia

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

Condition
Gout
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Muscle Shoals

Syed Research Consultants, LLC, Muscle Shoals, Alabama, United States, 35661

Covina

Medvin Clinical Research, Covina, California, United States, 91722

Clearwater

Clinical Research of West Florida, Inc., Clearwater, Florida, United States, 33765

Coral Gables

Herco Medical and Research Center, Inc, Coral Gables, Florida, United States, 33134

Hialeah

Direct Helpers Research Center, Hialeah, Florida, United States, 33012

Miami

Research Institute of South Florida, Inc., Miami, Florida, United States, 33173

Tampa

Clinical Research of West Florida, Inc., Tampa, Florida, United States, 33606

Winter Park

Conquest Research, LLC, Winter Park, Florida, United States, 32789

Newnan

Vista Clinical Research, LLC, Newnan, Georgia, United States, 30265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female subjects between the ages of 18 85 years, inclusive.
  • * Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
  • * 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 ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
  • * Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
  • * Subjects with secondary hyperuricemia, enzymatic defects.
  • * Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
  • * Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
  • * Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
  • * Subjects with a history of xanthinuria (elevated levels of xanthine in the urine) and rheumatoid arthritis

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

LG Chem,

Jisoo Lee, MD, STUDY_DIRECTOR, LG Chem

Study Record Dates

2025-06