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Tests treatment safety and results for Acute Gouty Arthritis
Official title A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
ClinicalTrials.gov ID: NCT07453004
What this study is testing
What is Plonmarlimab?
Plonmarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute gouty arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi center,randomized,double-blind,double-dummy,active-controlled study,and planned enrollment of 120-170 subjects,an interim analysis will be conducted after first 60 subjects complete the 72 -hour pain Visual Analogue Scale(VAS) assessment following their initial dose.Based on the analysis result，the sample size may be adjusted, and 1or 2 group(s）of the investigational drug will be selected to continue enrollment along with the active comparator group.The goal is to evaluate the efficacy of plonmarlimab in subjects with acute gouty arthristis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people aged ≥18 years, regardless of gender.
- people are willing to participate in this study and voluntarily sign the informed consent form.
- Meet the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria.
- Experienced ≥3 episodes of acute gout flare within the 12 months prior to baseline (determination of an acute gout flare based on patient history...
- people have experienced an acute gout flare within 5 days prior to administration of the investigational product (determination of an acute gout...
You likely can't join if
- Secondary gout caused by various etiologies (e.g., gout induced by chemotherapy, judged by the investigator based on the subject's medical history...
- History of hypersensitivity to any component of the investigational product or to similar biological agents.
- Contraindication to compound betamethasone therapy.
- Presence of other rheumatic diseases besides gout that may interfere with interpretation of results, including but not limited to rheumatoid...
- Pulmonary diseases including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary alveolar...
- Cardiovascular diseases: history of acute myocardial infarction, unstable angina, severe arrhythmia (multifrequent premature ventricular...
See the full eligibility criteria
Who can join
- people aged ≥18 years, regardless of gender.
- people are willing to participate in this study and voluntarily sign the informed consent form.
- Meet the 2015 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) gout classification criteria.
- Experienced ≥3 episodes of acute gout flare within the 12 months prior to baseline (determination of an acute gout flare based on patient history, referral records, etc., will be made by the investigator).
- people have experienced an acute gout flare within 5 days prior to administration of the investigational product (determination of an acute gout flare based on patient history, referral records, etc., will be made by...
- Contraindicated, intolerant, or inadequately responsive to colchicine and/or non-steroidal anti-inflammatory drugs (NSAIDs) (determination based on patient history, referral records, etc., will be made by the...
- Baseline pain intensity assessment in the most severely affected joint by the subject using a 0-100 mm Visual Analogue Scale (VAS) is ≥50 mm.
- people may or may not be receiving urate-lowering therapy. If planning to continue urate-lowering therapy during the study, it must have been at a stable dose for ≥2 weeks prior to baseline.
- people (including their partners) have no pregnancy plans from the screening period until 90 days after dosing and voluntarily agree to use effective contraception.
What rules you out
- Secondary gout caused by various etiologies (e.g., gout induced by chemotherapy, judged by the investigator based on the subject's medical history, referral records, etc.).
- History of hypersensitivity to any component of the investigational product or to similar biological agents.
- Contraindication to compound betamethasone therapy.
- Presence of other rheumatic diseases besides gout that may interfere with interpretation of results, including but not limited to rheumatoid arthritis, infectious/suppurative arthritis, traumatic arthritis, etc.
- Pulmonary diseases including but not limited to asthma, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary alveolar proteinosis, pulmonary granulomatosis, etc., or any underlying pulmonary...
- Cardiovascular diseases: history of acute myocardial infarction, unstable angina, severe arrhythmia (multifrequent premature ventricular contractions, ventricular tachycardia, ventricular fibrillation) within the past 6...
- History of malignancy within the past 5 years (regardless of treatment), except for successfully treated basal cell or squamous cell carcinoma of the skin.
- Other diseases: people with a past and/or current clinically significant, unstable, or uncontrolled acute or chronic disease unrelated to gout (e.g., acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute...
- Infections: presence of any known acute, chronic, or recurrent active infection during screening (e.g., tuberculosis, syphilis, HIV, HBV, HCV, Pneumocystis jirovecii, CMV, HSV, VZV, atypical mycobacteria, Histoplasma...
- Abnormal hepatic and renal function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) \> 2 × upper limit of normal (ULN); alkaline phosphatase (ALP) or total...
- Hematological diseases or abnormal routine blood tests: people with a past or current hematological disease including but not limited to myelofibrosis, aplastic anemia, leukemia, lymphoma, etc.; hemoglobin \< 90 g/L...
- Planned surgery or any other medical history (e.g., recent sepsis), laboratory abnormality, or other condition judged by the investigator to render the subject ineligible for this study.
- History of organ transplantation.
- Pregnant or lactating female people.
- Participation in any treatment clinical trial (including investigational vaccines) or use of an invasive investigational medical device within 3 months prior to enrollment, or current enrollment in another treatment...
- Administration of live (attenuated) vaccine within 30 days prior to screening. Inability to receive intramuscular injection (e.g., people on anticoagulants, thrombocytopenia, known bleeding disorders such as idiopathic...
- Drug abuse detected by urine drug screening, including morphine, ketamine, tetrahydrocannabinol, methamphetamine, MDMA, cocaine.
- Alcohol abuse within 3 months prior to screening, defined as alcohol consumption \> 14 units per week (1 unit = 17.5 mL or 14 g pure alcohol; 1 unit ≈ 35 mL of 50% spirits or 350 mL of 5% beer), or unwillingness to...
- Any other condition deemed by the investigator to render the subject unsuitable for this clinical study, including any condition that may increase study-related risk, interfere with evaluation of the investigational...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.