A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Phase II: 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 target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in Chinese participants with acute gout.
详细描述
The phase Ib study is a multi-center, open label, dose escalation study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection and to determine the target dose of phase II for the treatment of acute flare in Chinese gout patients in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. There are 3 dose groups (100 mg、200 mg and 300 mg) in phase Ib and 10 participants in each group.
The phase II study is a dose-ranging, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of 2 dose regimens (200 mg and 300 mg, based on the outcome of phase Ib) of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection for the treatment of acute flare in Chinese gout patients in whom NSAIDs and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. The phase II recommended dose of SSGJ-613 in subjects with acute gouty was determined according to the phase Ib interim analysis results.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 Years to 65 Years, both male and female
- •Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of acute arthritis of primary gout.
- •Presence of acute gout flare for no longer than 7 days
- •Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS
- •Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both
排除标准
- •Secondary gout (such as gout caused by chemotherapy, transplant gout, 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 3 months prior to the start of the study
- •Use of forbidden therapy
研究组 & 干预措施
SSGJ-613 300 mg (phase Ib)
Dose Arm 3 (phase Ib): SSGJ-613 300 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib) (Drug)
SSGJ-613 100 mg (phase Ib)
Dose Arm 1 (phase Ib): SSGJ-613 100 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib) (Drug)
SSGJ-613 200 mg (phase Ib)
Dose Arm 2 (phase Ib): SSGJ-613 200 mg subcutaneous (s.c) once. The s.c. injection could be administered into the abdomen or thigh.
干预措施: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib) (Drug)
SSGJ-613 200 mg (phase II)
Dose Arm 4 (phase II): 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 (phase II) (Drug)
SSGJ-613 300 mg (phase II)
Dose Arm 5 (phase II): SSGJ-613 300 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 low dose 300 mg (phase II) (Drug)
Compound Betamethasone Injection 1 mL (phase II)
Dose Arm 6 (phase II): 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 (phase II) (Drug)
Compound Betamethasone Injection 1 mL (phase II)
Dose Arm 6 (phase II): 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 (phase II) (Other)
结局指标
主要结局
Phase II: 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: Baseline, at 72 hrs 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).
Phase Ib: Incidence and Severity of Abnormalities in Vital Signs/Physical Examinations, Laboratory Examinations and Other Relevant Examinations
时间窗: From baseline through 24 weeks
To investigate the safety characteristics.
Phase Ib: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From baseline through 24 weeks
To investigate the safety characteristics.
次要结局
- Phase Ib: Pharmacokinetic (PK) Tmax(From baseline through 24 weeks)
- Phase Ib: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)(At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12, 16, 20, 24 Weeks post-dose)
- Phase II: The Pain Intensity in the Target Joint at 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)(At 6, 12, 24, 48, 72 Hours, 4, 5, 6, 7 Days, and 4, 8, 12 Weeks post-dose)
- Phase Ib: Pharmacokinetic (PK) Cmax(From baseline through 24 weeks)
- Phase Ib: Pharmacokinetic (PK) AUC 0-t(From baseline through 24 weeks)
- Phase Ib: Pharmacokinetic (PK) AUC 0-∞(From baseline through 24 weeks)
- Phase Ib: Pharmacokinetic (PK) t1/2(From baseline through 24 weeks)
- Percentage of Participants Taking Rescue Medication Within 7 Days After Study Drug Administration(7 days after study drug administration)
- The Time to At Least 50% Reduction of Baseline Pain Intensity in the Target Joint Within 7 Days after study drug administration(Baseline, within 7 days after study drug administration)
- The Change in Pain Intensity in the Target Joint From Baseline to 6, 12, 24, 48 Hours Post Dose as Measured on a 0-100 mm Visual Analog Scale (VAS)(Baseline, at 6, 12, 24, 48 hrs post-dose)
- The Time to Complete Pain Remission of Baseline Pain Intensity in the Target Joint Within 12 Weeks after study drug administration(Baseline, within 12 weeks after study drug administration)