Clinical trials: Uric Acid
Gout
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult…
- Trial name
- NCT05690204
- Testing
- SAP-001
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 87 people
- Sponsor
- Shanton Pharma Pte. Ltd.
Gout
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout.
- Trial name
- TRIPLE (NCT02598596)
- Testing
- Pegloticase, Azathioprine
- Where
- 11 sites in United States
- Volunteers
- 132 people
- Sponsor
- Ampel BioSolutions, LLC
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
Uncontrolled Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped…
- Trial name
- NCT04772313
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 15 sites in United States
- Volunteers
- 11 people
- Sponsor
- Amgen
Acute Gout Flare, Gout Attack
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
- Conditions
- Acute Gout Flare, Gout Attack, Gout Flare, Gouty Arthritis
- Trial name
- NCT05658575
- Testing
- Dapansutrile
- Where
- 40 sites in United States, France and 3 more
- Volunteers
- 300 people
- Sponsor
- Olatec Therapeutics, Inc.
Acute Gouty Arthritis
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
- Trial name
- NCT01356602
- Testing
- Canakinumab pre-filled syringe, Canakinumab lyophilized powder, Triamcinolone Acetonide
- Where
- 99 sites in United States, Canada and 3 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Gout
A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers
To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.
- Trial name
- NCT04047394
- Testing
- PEGylated recombinant candida urate oxidase
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Gout
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels.
- Trial name
- NCT02464605
- Testing
- SEL-037 (pegsiticase)
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Selecta Biosciences, Inc.
Gout
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout.
- Trial name
- NCT00080210
- Testing
- Puricase
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Savient Pharmaceuticals
Gout
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the…
- Trial name
- RELEASE (NCT07280156)
- Testing
- PRX-115, Methotrexate (MTX)
- Where
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 150 people
- Sponsor
- Protalix
Gout
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels
This is a Phase 1, double-blind, placebo-controlled, single ascending dose study in participants with elevated uric acid levels.
- Trial name
- NCT05745727
- Testing
- PRX-115
- Where
- 2 sites in New Zealand
- Volunteers
- 64 people
- Sponsor
- Protalix
Gout
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
The purpose of this study is to: Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants Part B: Evaluate the safety, tolerability and efficacy of ALN-XDH as monotherapy in…
- Trial name
- NCT05256810
- Testing
- ALN-XDH
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Hyperuricosuria, Kidney Stones
Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.
- Trial name
- NCT01077284
- Testing
- Febuxostat, Allopurinol
- Where
- 28 sites in United States
- Volunteers
- 99 people
- Sponsor
- Takeda
Hyperuricemia, Gout
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Trial name
- NCT04987242
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Allena Pharmaceuticals
Gout, Hyperuricemia
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease
- Trial name
- NCT01407874
- Testing
- Ulodesine (BCX4208) 5 mg, Ulodesine (BCX4208) 10 mg
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- BioCryst Pharmaceuticals
Hyperuricemia, Gout
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout.
- Trial name
- NCT01416402
- Testing
- Arhalofenate, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Gilead Sciences
Gout, Gout Initiating Urate-loweringUrate-lowering Therapy
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
- Trial name
- Gensci 048-202 (NCT05936281)
- Testing
- Genakumab for injection, Colchicine
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Gout Flares
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the inflammatory response in gouty arthritis.
- Trial name
- NCT01712204
- Testing
- AC-201, Febuxostat
- Where
- Taiwan
- Volunteers
- 82 people
- Sponsor
- TWi Biotechnology, Inc.
Asymptomatic Hyperuricemia
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat +…
- Trial name
- NCT03316131
- Testing
- Verinurad, Febuxostat, Dapagliflozin
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
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