A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
详细描述
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must be 18 Years to 75 Years, both male and female.
- •BMI ≤35 kg/m
- •Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
- •History of ≥ 3 gout flares within the 12 months prior to study randomization.
- •Onset of current acute gout flare within 4 days prior to study screening.
- •Screening pain intensity of the Target Joint ≥ 50 mm on the 0-100 mm VAS.
- •Contraindicated, intolerant or lack efficacy to NSAIDs and/or colchicine.
- •Accept uric acid lowering treatment according to the requirements of the protocol.
排除标准
- •Gout caused by radiotherapy/chemotherapy, lead, organ transplantation, tumors, etc.
- •Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
- •Presence of severe renal function impairment.
- •Intolerance of subcutaneous and intramuscular injection.
- •Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
- •History of malignant tumor within 5 years before screening.
- •Live vaccinations within 8 weeks prior to the start of the study.
- •Use of forbidden therapy.
研究组 & 干预措施
Compound Betamethasone Injection 1 mL
Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
干预措施: Placebo (Other)
SSGJ-613 200 mg
SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (Drug)
SSGJ-613 200 mg
SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh. Randomized patients will receive one s.c. injection of SSGJ-613 and placebo matching compound betamethasone injection (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection is recommended to be administered deeply into the gluteal muscle.
干预措施: Placebo (Other)
Compound Betamethasone Injection 1 mL
Compound betamethasone injection 1 mL intramuscularly (i.m) once. The i.m. injection is recommended to be administered deeply into the gluteal muscle. Randomized patients will receive compound betamethasone injection 1 mL i.m. once and placebo matching SSGJ-613 s.c. once, on Day 1.
干预措施: Compound Betamethasone Injection (Drug)
结局指标
主要结局
The Change in Pain Intensity in the Target Joint From Baseline to 72 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)
时间窗: 72 hours post-dose
The change in pain intensity from baseline to 72 hours post dose as measured on a 0-100 mm Visual Analog Scale (VAS): 0= no pain and 100= severe pain. Change from baseline = (post-baseline measurement - baseline).
Time to First New Flare
时间窗: 12 weeks
The Kaplan Meier method was used to estimate the median time and 95% CI of the first new flares within 12 weeks after the first administration of each group, as well as the event incidence and 95% CI at 12 weeks.
次要结局
- Percentage of Participants Taking Rescue Medication After Study Drug Administration and Categories and Dosages of Rescue Medication(12 weeks, 24 weeks, 48 weeks)
- Likert scores for target joint pain(7 days, 12 weeks, 24 weeks)
- Number of new gout flares(12 weeks, 24 weeks, 48 weeks)
- The Change in Pain Intensity in the Target Joint From Baseline to 6, 24, 48 Hours and 7 Days Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)(At 6, 24, 48 hours and 7 Days post-dose)
- The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint after study drug administration(Up to 48 weeks)
- The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint after study drug administration(Up to 48 weeks)
- Percentage of Participants with Complete Pain Remission of the Target Joint within 12 weeks after study drug administration(12 weeks)
- Time to first use of Rescue Medication(Within 7 days after the first administration, within 7 days after the last acute attack of gout during the double blind treatment period)
- Time to First New Flare(24 weeks, 48 weeks)
- Percentage of Participants with at least 1 new gout flare(12 weeks, 24 weeks, 48 weeks)