Gout

27

Review clinical trials related to Gout. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time

To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.

Participants needed: 142
Trial details
Phase: Phase 4Age: 18-70Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Wenzhou Medical UniversityUpdated: Jun 22, 2026
Eligibility criteria

Male or female individuals aged 18-70 years old. [+4]

Has secondary hyperuricemia. [+14]

Status: Not yet recruiting

Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different. The primary purpose of this observational study is to evaluate the diagnostic performance of musculoskeletal ultrasound (MSUS) in distinguishing between RA and GA. Ultrasound is a safe, radiation-free imaging tool that can visualize joint inflammation and structural changes in real-time. This study utilizes a structured semi-quantitative scoring system (graded on a scale of 0 to 3) to systematically measure the severity of joint lining thickness (synovial hypertrophy) and active blood flow (power Doppler signal). It also checks for crystal-related deposits, such as tophi or the double contour sign, which are highly suggestive of gout. Participants aged 18 and older with suspected or confirmed RA or GA who are referred for joint assessment at Assiut University Hospitals will undergo a standard clinical evaluation, routine laboratory testing, and an ultrasound examination of specific target joints (such as the wrists, hands, knees, and ankles). By comparing the ultrasound scores and specific structural findings between the two patient groups, the study aims to establish a reliable, standardized imaging approach to help physicians make faster, more confident diagnoses and initiate the correct disease-specific therapies sooner.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assiut UniversityUpdated: Jun 18, 2026
Eligibility criteria

Patients aged 18 years or older. [+6]

Patients younger than 18 years. [+7]

Status: Recruiting

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 respective placebos in adult patients with gout.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: ProtalixUpdated: Jun 11, 2026Locations: 27
Eligibility criteria

Males or females ≥18 years of age. [+4]

Any condition known to have arthritis as a clinical manifestation. [+19]

Status: Recruiting

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.

Participants needed: 90
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Crystalys TherapeuticsUpdated: Jun 10, 2026Locations: 17
Eligibility criteria

Between 18 and 75 years of age (inclusive) at the time of signing informed conse... [+5]

History of or presence of kidney stones within 1 year prior to Screening. [+4]

Status: Recruiting

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.

Participants needed: 500
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Crystalys TherapeuticsUpdated: Jun 8, 2026Locations: 100
Eligibility criteria

Between 18 and 75 years of age (inclusive) at the time of signing informed conse... [+6]

History of or presence of kidney stones within 1 year prior to Screening. [+5]

Status: Recruiting

Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration

Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered. However, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol / l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration. This study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.

Participants needed: 128
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, RouenUpdated: Jun 8, 2026Locations: 6
Eligibility criteria

Patients with an attack of gout, diagnosed immediately or less than 5 days old.... [+8]

Patients under the age of 18, [+16]

Status: Recruiting

The Remote Monitoring of Gout Feasibility Study in Primary Care

The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are: 1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up. 2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care. Participants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Diakonhjemmet HospitalUpdated: Apr 30, 2026Locations: 1
Eligibility criteria

Adults ≥18 years of age at screening [+8]

Status: Recruiting

the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More

The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group. During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \<7.0 mg/dL after reducing or suspending urate-lowering therapy.

Participants needed: 59
Trial details
Phase: Phase 4Age: 19-79Biological sex: AllType: InterventionalSponsor: Seoul National University HospitalUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Adult gout patients aged ≥19 but <80 years. [+5]

Subjects who continuously require prophylactic low-dose colchicine/NSAIDs. [+8]

Status: Recruiting

Drug-Drug Interaction Study of ABP-671 in Gout Patients

This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.

Participants needed: 20
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Atom Therapeutics Co., LtdUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Adults 18-75 years with clinical diagnosis of gout. [+3]

Clinically significant hepatic impairment. [+2]

Status: Recruiting

Dose Response of Exercise for Arthritis Management

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

Participants needed: 285
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of South CarolinaUpdated: Apr 3, 2026Locations: 1
Eligibility criteria

18 years or older [+2]

Have any contraindications to exercise (besides arthritis) [+8]

Status: Recruiting

Tight Control of Gouty Arthritis Compared to Usual Care

Gout is caused by a reaction to urate crystals that results in attacks of severe joint pain. Medicines that lower urate levels can prevent gout flares, however it takes time for this benefit to be felt, and paradoxically starting treatment with large doses of urate lowering treatment risks provoking attacks of gout. Medical guidelines disagree on the best way to overcome these challenges with many recommending medicine dose adjustment based on regular urate testing but a general practice guideline suggesting more simply increasing the medicine dose in those patients that continue to suffer flares. In reality most patients are not treated at all, and many of those that are treated never receive an effective dose of treatment. We have developed a supported self-management approach to gout in which patients monitor their own urate levels using a finger prick test, and then receive advice on adjusting their treatment dose to achieve target urate levels through a smartphone app (Gout SMART). A trial of this approach has shown that it results in much better control of urate levels after 6 months than usual care, and suggests that it also leads to fewer flares. We would now like to confirm that this approach is effective in reducing flares of gout over 2 years by randomising patients to either treatment-to-target urate using our self-monitoring approach, or to usual care.

Participants needed: 125
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of EdinburghUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

Provision of informed consent. [+5]

Subject unable to provide consent [+3]

Status: Recruiting

The Orienting Study

This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.

Participants needed: 450
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUpdated: Mar 31, 2026Locations: 1
Eligibility criteria

Patients diagnosed with CPPD disease according to the ACR/EULAR 2023 classificat... [+11]

Known history of other inflammatory arthropathies [+3]

Status: Recruiting

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. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.

Participants needed: 600
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)Updated: Mar 25, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years, male or female. [+3]

History of allergy or intolerance to any component of febuxostat or Tigulixostat... [+14]

Status: Recruiting

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.

Participants needed: 300
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Olatec Therapeutics LLCUpdated: Mar 11, 2026Locations: 40
Eligibility criteria

Male and female subjects age 18 or older [+2]

Presence of any palpable and visible tophi by physical examination [+11]

Status: Not yet recruiting

Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout

This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.

Participants needed: 310
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Feb 19, 2026Locations: 5
Eligibility criteria

US Veterans over the age of 18 years with physician-diagnosed [+4]

Any patient intolerant or unable to take ULTs (allopurinol or febuxostat) [+1]

Status: Recruiting

Time Required to Dissolve Urate Deposits

Gout is characterized by episodes of acute arthritis of the lower limbs due to intermittent activation of innate immunity in the joints where urate crystals have formed. These crystals occur when serum urate (SUA) levels have been above 70 mg/L for many years. They can be dissolved by lowering SUA levels to at least 60 mg/L (treat-to-target - T2T - strategy). Once the crystals are dissolved, patients are no longer symptomatic and are considered to be in remission (treat-to-dissolve - T2D - strategy). The presence of crystals and their dissolution during treatment can be monitored by repeated ultrasound (US) scans of the feet and knees. The time required for complete dissolution varies from patient to patient. ReViGore40 is a cohort designed to i) determine the time to complete dissolution of urate deposits in joints when SUA levels are maintained below 40 mg/L, ii) determine the factors (clinical, biological, genetic) associated with the time required for complete dissolution of urate deposits within joints.

Participants needed: 250
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Feb 19, 2026Locations: 1
Eligibility criteria

Age over 18 years [+4]

Ongoing urate lowering therapy [+3]

Status: Recruiting

Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares

This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare. The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period. The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18-90Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Signed informed consent to participate in this study [+9]

Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal o... [+13]

Status: Recruiting

Improving Gout Care After an ED Visit

The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.

Participants needed: 200
Trial details
Age: 18-99Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

≥ 18 years old [+2]

Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention emp...

Status: Not yet recruiting

Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT

A total of 120 obese gout patients were included in a 24-week double-blind randomized controlled design. The intervention group received orlistat 120 mg tid + UTL + individualized diet-exercise-behavioral reinforcement weight loss program, while the control group received a placebo + UTL + standard recommendations. The primary endpoint was the rate of achieving serum uric acid levels \<360 μmol/L at 24 weeks; secondary endpoints included the proportion of weight loss ≥5%, frequency of gout attacks, and inflammatory indicators such as CRP and IL-1β; the activity of AMPK in PBMCs and the expression of HIF1α and NLRP3 inflammasome-related proteins were also assessed.

Participants needed: 120
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: XueMei GuoUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

Meeting the 2015 ACR/EULAR classification criteria for gout. [+4]

Contraindications to orlistat or other gout medications. [+7]

Status: Recruiting

A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.

Participants needed: 36
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Shanghai Institute Of Biological ProductsUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

Willing and able to give informed consent. [+7]

Patients had active systemic infection within 2 weeks before enrollment,includin... [+25]

Status: Recruiting

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.

Participants needed: 650
Trial details
Phase: Phase 4Age: 18-90Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Sep 25, 2025Locations: 7
Eligibility criteria

Provide signed written or electronic informed consent. [+7]

Diagnosis of CKD Stage 3B or worse (eGFR < 45 mL/min/ 1.73 m2) at screening [+10]

Status: Recruiting

Metformin in Safety and Efficacy in Gouty Patients

The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients

Participants needed: 70
Trial details
Phase: Phase 2Age: 18-60Biological sex: AllType: InterventionalSponsor: Mostafa BahaaUpdated: Jun 27, 2025Locations: 1
Eligibility criteria

Gouty patients clinically diagnosed as gouty arthritis based on the American Col...

Systemic disorders such as cardiovascular, neurological, coronary artery disease... [+4]

Status: Recruiting

Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients

Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (\>6.8 mg/dl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks

Participants needed: 60
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Mostafa BahaaUpdated: Jun 24, 2025Locations: 1
Eligibility criteria

Males or females aged < 18 years. [+2]

The presence of any type of diabetes mellitus. [+3]

Status: Recruiting

Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Shenyang Sunshine Pharmaceutical Co., LTD.Updated: May 28, 2025Locations: 1
Eligibility criteria

A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout... [+1]

Within 14 days prior to enrollment (or within 5 half lives of the drug, whicheve... [+5]

Status: Recruiting

Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout

Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Mar 19, 2025Locations: 1
Eligibility criteria

Not listed