Clinical trials: Gout
Gout Disease
Combined Metabolic Activator Supplementation in Subjects Diagnosed With Gout
This will be a randomised, double-blind, placebo-controlled, multi-centre study with the aim to establish metabolic improvements in individuals diagnosed with hyperuricemia associated with gout by treatment with CMA2 including…
- Trial name
- NCT07889284
- Testing
- Combined metabolic activators, Collagen and maltodextrin
- Where
- 12 sites in Turkey (Türkiye)
- Volunteers
- 336 people
- Sponsor
- ScandiBio Therapeutics AB
Uncontrolled Gout
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response…
- Trial name
- NCT07388498
- Testing
- Pegloticase, Methotrexate
- Where
- 75 sites in United States, Puerto Rico
- Volunteers
- 270 people
- Sponsor
- Amgen
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06439602
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 68 sites in United States, Australia and 3 more
- Volunteers
- 818 people
- Sponsor
- Arthrosi Therapeutics
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, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06846515
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 83 sites in United States
- Volunteers
- 866 people
- Sponsor
- Arthrosi Therapeutics
Gout
A Study of Dotinurad Versus Allopurinol in Participants With Gout
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
- Trial name
- NCT07089875
- Testing
- Allopurinol, Dotinurad
- Where
- 115 sites in United States, Poland and 1 more
- Volunteers
- 500 people
- Sponsor
- Crystalys Therapeutics
Tophaceous Gout
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.
- Trial name
- NCT07089888
- Testing
- Allopurinol, Dotinurad
- Where
- 95 sites in United States
- Volunteers
- 250 people
- Sponsor
- Crystalys Therapeutics
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
Hyperuricemia, Gout
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.
- Trial name
- NCT01336686
- Testing
- Arhalofenate, Colchicine
- Where
- 12 sites in United States
- Volunteers
- 67 people
- Sponsor
- Gilead Sciences
Gout, Hyperuricemia
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.
- Trial name
- NCT02252835
- Testing
- Arhalofenate, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Gout
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase…
- Trial name
- NCT06229145
- Testing
- Pegloticase, Methotrexate
- Where
- 74 sites in United States
- Volunteers
- 306 people
- Sponsor
- Amgen
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
Study of Safety, PK, and Efficacy of Multiple Ascending Doses of HZBio1 in Patients With Gout
Study YDHY (HZBio1)-001 (Ib/Ⅱ) is an open-label, dose-escalation and expansion, multicenter Phase Ib/II clinical trial conducted in China.
- Trial name
- NCT07752810
- Testing
- Phase 1b: HZBio1 3mg, Phase 1b: HZBio1 6mg, Phase 1b: HZBio1 12mg
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
Hyperuricemia With or Without Gout
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after…
- Trial name
- NCT07346027
- Testing
- Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg), Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Gout Arthritis
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment
- Trial name
- NCT07708181
- Testing
- SSGJ-613 100 mg Q12W, SSGJ-613 200 mg Q12W, SSGJ-613 100 mg Q4W
- Volunteers
- 200 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Gout
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
- Trial name
- NCT05665699
- Testing
- D-0120, Allopurinol
- Where
- 19 sites in United States
- Volunteers
- 80 people
- Sponsor
- InventisBio Co., Ltd
Gout
To Evaluate the Influence of (LUA Probiotics) on Uric Acid
This study aims to investigate the efficacy of the lactic acid bacteria "LUA probiotics" in reducing serum uric acid levels. The use of health supplements prior to the onset of gout symptoms is proposed as a preventive strategy…
- Trial name
- NCT06969469
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- Grape King Bio Ltd.
Hyperuricemia With or Without Gout
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple…
- Trial name
- NCT07324434
- Testing
- F-02-2-Na Tablet (0.5 mg), F-02-2-Na Tablet (5 mg), F-02-2-Na Tablet (10 mg)
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Gout, Hyperuricemia
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to…
- Trial name
- NCT06056570
- Testing
- dotinurad, dotinurad + allopurinol, allopurinol
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Urica Therapeutics Inc.
Acute Gout Flare
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare…
- Trial name
- NCT07295496
- Testing
- IBI3011
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.