A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 423
- 试验地点
- 1
- 主要终点
- Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
研究概览
简要总结
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients with Prurigo Nodularis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol.
- •The age was ≥18 at the time of signing the informed consent and gender is unlimited.
- •Has prurigo nodularis at screening.
排除标准
- •Pregnant or lactating women.
- •Screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening.
- •Has an active skin disease or skin complications due to other diseases that may affect the evaluation of PN.
- •PN secondary to medical conditions such as neurological or psychiatric disorders.
- •Diagnosis of moderate to severe AD during the screening/lead-in period or prior to randomization.
- •History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis.
- •Phase II: Treated with biologics targeting IL-4Rα, or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection. Phase III: Subjects who have previously received anti-IL-4Rα biologics for any indication including atopic dermatitis (AD), asthma, sinusitis, etc., and were judged by the investigator to have an inadequate response or intolerance (e.g., experienced drug-related adverse reactions requiring treatment discontinuation) must be excluded even if the washout requirement is met.
- •Subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence).
- •Major surgeries are planned for the duration of the study.
- •Other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
研究组 & 干预措施
SHR-1819 Injection Group
SHR-1819 injection with different doses.
干预措施: SHR-1819 Injection (Drug)
SHR-1819 Injection Placebo Group
SHR-1819 injection placebo.
干预措施: SHR-1819 Injection Placebo (Drug)
结局指标
主要结局
Phase II: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
时间窗: Up to 16 weeks.
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Phase III: Proportion of subjects with a ≥ 4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24
时间窗: Up to 24 weeks.
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Phase II: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 16
时间窗: up to 16 weeks
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
Phase III: Proportion of subjects with a ≥4-point reduction from baseline in the weekly mean of the Most Intense Pruritus Numeric Rating Scale (WI-NRS) at Week 24
时间窗: up to 24 weeks
Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity.
次要结局
- Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS(Up to 16 weeks.)
- Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16(Up to 16 weeks.)
- Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16(Up to 16 weeks.)
- Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at Week 24(Up to 24 weeks.)
- Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at every study visit(Up to 52 weeks.)
- Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at every study visit(Up to 52 weeks.)
- Phase II/III: The concentration of SHR-1819 in serum (AUC)(From the beginning of administration to the 24/60th week.)
- Phase II/III: Changes in the level of IgE in the serum(From the beginning of administration to the 24/60th week.)
- Phase II/III: Immunogenic endpoint - evaluate the incidence of ADA positivity for SHR-1819(From the beginning of administration to the 24/60th week.)
- Phase II: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12 and 16(up to 16 weeks)
- Phase II: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16(up to 16 weeks)
- Phase II: Weekly mean change from baseline and percentage change in weeks 2, 4, 8, 12, and 16 of WI-NRS(up to 16 weeks)
- Phase III: Proportion of subjects with an IGA CNPG-S score of 0/1 at week 24(up to 24 weeks)
- Phase III: Proportion of subjects with IGA CNPG-S score of 0/1 at weeks 4, 8, 12, 16, and 20(up to 24 weeks)
- Phase III: Change from baseline in Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, 24(up to 24 weeks)
- Phase II/III: The concentration of SHR-1819 in serum: AUC(From the beginning of administration to the 24/32th week)
- Phase II/III: Changes in the level of IgE in the serum(From the beginning of administration to the 24/32th week)
- Phase II/III: Immunogenic endpoint: evaluate the incidence of ADA positivity for SHR-1819(From the beginning of administration to the 24/32th week)