Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
NCT05586971
Phase
Phase 3
Recruitment status
Completed
Participants
2,202
Lead sponsor
LG Chem
Start date
2023-03-30
Number of sites
- Summary
- The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
- Acronym
- EURELIA2
- Short title
- Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
- Official title
- A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2025-05-06
- First posted
- 2022-10-19
- Registry last updated
- 2025-07-22
- Primary completion date
- 2025-05-06
- Start date
- 2023-03-30
- Actual participants
- 2,202
- Participants
- 2,202
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- LG Chem
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05586971
- ClinicalTrials.gov ID
- NCT05586971
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
The proportion of subjects with sUA levels <6.0 mg/dL sustained at months 4, 5, and 6
Timeframe: Up to Month 6
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
The proportion of subjects with sUA levels <5.0 mg/dL sustained at months 4, 5, and 6
Timeframe: Up to Month 6
Serum uric acid (sUA) level will be measured at Month 4,5, and 6
Proportion of subjects with at least one gout flare from Month 6 to Month 12.
Timeframe: From Month 6 to Month 12
Gout flare (intense pain, swelling, or/and tenderness in the joint area) will be assessed from baseline up to 12 months
Proportion of subjects with complete resolution of ≥1 target tophus by Month 12
Timeframe: Up to Month 12
Tophi will be measured by independent central blind reader
Incidence rate of adverse event
Timeframe: Up to Month 12
Safety assessment
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Healthy volunteers
- No
- 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 and 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).
Sources for eligibility
- University of Alabama at BirminghamBirmingham, United States
- Alliance for Multispecialty Research, LLCDaphne, United States
- Alliance for Multispecialty Research, LLCMobile, United States
- Syed Research Consultants, LLCMuscle Shoals, United States
- Syed Research Consultants, LLCSheffield, United States
- Arizona Research Clinic, PLLCChandler, United States
- Arizona Arthritis & Rheumatology Associates, P.C.Flagstaff, United States
- Arizona Arthritis and Rheumatology Research PLLCGlendale, United States
- Arizon Arthritis & Rheumatology Research, PLLCMesa, United States
- Desert Clinical Research/CCT ResearchMesa, United States
- Elite Clinical Studies, LLCPhoenix, United States
- Fiel Family and Sports Medicine/CCT ResearchTempe, United States
- Lynn Institute of the OzarksLittle Rock, United States
- Velocity Clinical ResearchBanning, United States
- American Clinical TrialsBuena Park, United States
- Shreenath Clinical ServiceLakewood, United States
- Rancho Cucamonga Clinical ResearchRancho Cucamonga, United States
- TriWest Research AssociatesSan Diego, United States
- Rheumatology Center of San DiegoSan Diego, United States
- Arthritis & Rheumatic Disease SpecialtiesAventura, United States
- Clinical Research of West Florida, Inc.Clearwater, United States
- Herco Medical and Research Center, IncCoral Gables, United States
- Nouvelle Clinical Research LLCCutler Bay, United States
- Omega Research Debary, LLCDeBary, United States
- Alliance for Multispecialty Research, LLCFort Myers, United States
And 254 more, listed on the interactive page.
Sources for sites
- PubMed 39929260Related publication
Sources for references
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Gout Primary condition