Clinical trials: Gout Disease
Gout, Hyperuricemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.
- Trial name
- NCT03906006
- Testing
- ABP-671
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Atom Therapeutics Co., Ltd
Gout
MPC-004 for the Treatment of an Acute Gout Flare
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or…
- Trial name
- AGREE (NCT00506883)
- Testing
- High Dose Colchicine (4.8 mg total dose), Low Dose Colchicine (1.8mg total dose)
- Where
- 83 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Takeda
Gout, Hyperuricemia
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
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…
- Conditions
- Gout, Hyperuricemia, Gout Flare, Tophi
- Trial name
- EURELIA2 (NCT05586971)
- Testing
- Tigulixostat, Allopurinol
- Where
- 279 sites in United States, Argentina and 19 more
- Volunteers
- 2,202 people
- Sponsor
- LG Chem
Gout
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment.
- Trial name
- NCT00610363
- Testing
- Rilonacept
- Where
- 34 sites in United States
- Volunteers
- 83 people
- Sponsor
- Regeneron Pharmaceuticals
Gout
Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.
- Trial name
- NCT02063997
- Testing
- Arhalofenate 600 mg, Allopurinol 300 mg, Colchicine 0.6 mg
- Where
- 56 sites in United States, Canada and 1 more
- Volunteers
- 248 people
- Sponsor
- Gilead Sciences
Gout
A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
- Trial name
- NCT07535034
- Testing
- Dotinurad
- Where
- 41 sites in United States
- Volunteers
- 90 people
- Sponsor
- Crystalys Therapeutics
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal…
- Trial name
- β-RELIEVED-II (NCT01080131)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 108 sites in United States, Canada and 3 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Gouty Arthritis
Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France
This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS).
- Trial name
- NCT05964946
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Gout
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208.
- Trial name
- NCT00985127
- Testing
- BCX4208
- Where
- 24 sites in United States
- Volunteers
- 99 people
- Sponsor
- BioCryst Pharmaceuticals
Primary Gout, Hyperuricemia
Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia.
- Trial name
- NCT06603142
- Testing
- Febuxostat 20MG Tablets, AR882 25MG, AR882 12.5MG
- Where
- China
- Volunteers
- 636 people
- Sponsor
- Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
Gouty Arthritis (GA)
A Bioequivalence Study of Two Different Dosage Form of Genakumab
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
- Trial name
- NCT06451848
- Testing
- Genakumab Injection (T, Solution for injection), Genakumab for Injection (R, Powder for solution for injection)
- Where
- China
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Gout
Tigulixostat (IBI128) vs Febuxostat in Gout
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.
- Trial name
- NCT07414394
- Testing
- Febuxostat, Tigulixostat
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
Gout
Lesinurad and Febuxostat Combination Extension Study in Gout
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
- Trial name
- NCT01808144
- Testing
- lesinurad, febuxostat
- Where
- 72 sites in United States, Australia and 4 more
- Volunteers
- 196 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Gout, Hyperuricemia
Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with…
- Trial name
- NCT03857165
- Testing
- SAP-001
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Shanton Pharma Co., Ltd.
Gout
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
- Trial name
- APEX (NCT00174915)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 1,072 people
- Sponsor
- Takeda
Gout, Hyperuricemia
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.
- Trial name
- NCT06189404
- Testing
- Tigulixostat, Theophylline
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Gout, Hyperuricemia
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees…
- Trial name
- NCT06729853
- Testing
- SAP-001
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Pte. Ltd.
Gout, Hyperuricemia
The Effect of Colchicine on the Pharmacokinetic Profile of LC350189 in Healthy Aldults.
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the PK, PD, safety, and tolerability of LC350189 and colchicine when administered alone and in combination in healthy…
- Trial name
- NCT03927677
- Testing
- Xanthine Oxidase Inhibitor
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Gout
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.
- Trial name
- NCT01736514
- Testing
- febuxostat, Allopurinol
- Where
- 4 sites in Taiwan
- Volunteers
- 109 people
- Sponsor
- Astellas Pharma Taiwan, Inc.