NCT07842497尚未招募2 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI3011 for Acute Gouty Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The change in the gout pain intensity in the target joint measured by VAS
研究概览
简要总结
It is a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanized monoclonal antibody injection in subjects with acute gout flare
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and sign the informed consent form;
- •Aged 18 to 75 years, male or female, male or female;
- •Body Mass Index (BMI) between 18.0 kg/m² and 40.0 kg/m²;
- •Meets the 2015 American College of Rheumatology (ACR) Gout Classification Criteria;
- •Has a history of at least 2 gouty arthritis flares within 1 year prior to study drug administration;
- •With an acute gouty arthritis flare occurring within 4 days before study drug administration;
- •Has contraindications to, intolerance of, or inadequate response to colchicine and/or nonsteroidal anti-inflammatory drugs (NSAIDs);
- •At screening, has a Visual Analogue Score (VAS) pain score of ≥50 mm (on a 0-100 mm scale) in the target joint affected by the acute gout flare
- •Agrees to comply with the protocol-specified urate-lowering therapy (ULT) during the study period;
- •Has no childbearing plans and can use adequate contraceptive measures during the trial period and for 6 months after the last dose of study drug
- •Subjects meeting any of the following criteria are not eligible to attend this clinical study:
- •Have a history of specific allergies (such as asthma, urticaria, eczema, etc.) or hypersensitivity reactions to previous use of biological agents, or atopic diathesis (e.g., allergies to two or more types of drugs, foods, and pollen);
- •Difficulties in venous blood collection or history of dizziness when encountering blood or needles;
- •Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
- •Have live or attenuated vaccination in the 3 months prior to randomization or plan to receive that during the this trial;
- •Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
- •Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening;
- •Have infection requiring systemic therapy within 30 days before randomization or has persistent infection before the screening;
- •Presence of infection requiring systemic drug treatment, hospitalization for infection, or receipt of intravenous antibiotics within 30 days before randomization, or ongoing infection at screening
- •Unable to receive intramuscular injection, such as current anticoagulation therapy, thrombocytopenia, or diseases with a risk of thrombocytopenia, such as aplastic anemia, hypersplenism, or known hemorrhagic diseases like idiopathic thrombocytopenic purpura or hemophilia, or chronic periodontal disease;
- •History of malignancy;
- •Female during pregnancy or lactation;
- •Female (or male) of child-bearing potential has childbearing (or sperm donation) plan or reject to use effective contraceptive methods from the screening period to 6 months after the last dose of the investigational product;
- •Average daily alcohol intake exceeding 2 units within 3 months before screening (i.e., more than 1 bottle [500 mL] of beer, 50 mL of 52% alcohol content baijiu, or half a bottle [350 mL] of wine per day on average), or alcohol consumption within 48 hours before drug administration;
- •Have a history of drug abuse, drug dependence, or a positive result in drug screen within 12 months before the screening;
- •Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) with HBV DNA, or hepatitis C virus (HCV) antibody;
- •Have a history of prolonged QT interval, or QTc > 450ms for males and > 470ms for females during the screening;
- •Meets any of the following conditions:
- •Confirmed active tuberculosis infection: including but not limited to radiologically confirmed active tuberculosis infection
- •Participants with latent tuberculosis infection or at high risk of tuberculosis infection may be enrolled, but those considered unsuitable by the investigator will be excluded, such as participants unwilling to continue anti-TB treatment according to local guidelines after enrollment;
- •Received following drugs or therapy within the specified time before to the drug administration:
- •a) Glucocorticoids: i. Systematic used ≥10mg prednisone or same dose hormone within 24 hours before administration; ii. Longer-term treated with glucocorticoids; iii. Target joint injected glucocorticoid hormone within14 days before administration; iv. Intramuscular or intravenous injected glucocorticoids within 14 days before administration; b) Used anesthetics (Opiates or tramadol) within 24 hours before administration; c) Used NSAIDS and other analgesics within one half-life before drug administration; d) Used colchicine within 12 hours before administration; e) Applied with ice treatment within 4 hours before administration; f) Used any IL-1 blockers, TNF inhibitors, or other biologics preparation within 30 days or within 5 half-lives before administration (whichever is longer);
- •Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
- •Infection/septic arthritis, or other acute inflammation arthritis;
- •Meet any of the following clinical laboratory tests during the screening:
- •Total bilirubin (TBIL) > 1.5 upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 3 ULN;
- •Blood triglycerides >300mg/dL or >3.42mmol/L, or a moderate or greater degree of splenomegaly indicated by splenic ultrasound or physical examination;
- •Estimated Glomerular filtration rate (EDFR) ≤60 ml/min/1.73 m2;
- •Suffering the following diseases, including but not limited to:
- •Refractory hypertension or blood pressure higher than 180/110 mmHg during the screening;
- •Uncontrolled diabetes;
- •History of congestive heart failure;
- •Myocardial Infarction (MI), Angina Pectoris, Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft Surgery (CABG), Intracerebral Hemorrhage (ICH), Cerebral Infarction (CI) within 6 months before the screening;
- •Stage 3 chronic kidney disease or requiring dialysis treatment;
- •Reassessment of VAS pain score in the target joint <50 mm immediately before drug administration;
- •History of neuropsychiatric disorders, or considered unsuitable for participation in this clinical trial by the investigator
排除标准
- 未提供
研究组 & 干预措施
Compound Betamenth Group
Active Comparator
Intramuscular injection 2ml/bottle
干预措施: Compound Betamenth Group (Drug)
IBI3011 GROUP
Experimental
Subcutaneous injection 300mg/bottle
干预措施: IBI3011 GROUP (Drug)
结局指标
主要结局
The change in the gout pain intensity in the target joint measured by VAS
时间窗: 72 hours post-dose
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
次要结局
- Percent Patients Who Took Rescue Medication(up to 24 weeks)
- Time to first flare(up to 24 weeks)
- Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)(up to 24 weeks)
- The change in the gout pain intensity in the target joint measured by VAS.(up to 24 weeks)
- The number of patients with at least 1 new gout flare(up to 24 weeks)
- Time to at Least a 50%，70% Reduction in Baseline Pain Intensity(up to 120 hours)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(up to 24 weeks)
- Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody(up to 12 weeks)
- Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period(up to 12 weeks)
- Time to achieve target joint pain intensity reduction to 20 mm, 10mm, based on VAS score(up to 120 hours)
- Changes from baseline in SF-36 Physical Functioning (PF) domain scores at each time point(up to 12 weeks)
- Levels and changes from baseline of IL-6, TNF-α, hsCRP, and NLR in peripheral blood(up to 12 weeks)
- Levels and changes from baseline of soluble proteins in peripheral blood(up to 12 weeks)
- Changes in IL-1RAP receptor occupancy in peripheral blood(up to 12 weeks)
研究者
研究点 (1)
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