NCT04204616进行中（未招募）3 期
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Incidence of Adverse Events (AEs) by Severity
研究概览
简要总结
The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants who may benefit from study participation in the opinion of the investigator and participated in a prior nemolizumab study for PN including: (a). Participants who completed the treatment period in a phase 3 pivotal study (NCT04501666 or NCT04501679) and enroll within 56 days OR (b). Participants who were previously randomized in the nemolizumab phase 2a PN study (NCT03181503) OR (c). Participants who completed through Week 24 of the phase 3b durability study (NCT05052983) or who exit the study due to relapse may be eligible to re-enter in the LTE study within 28 days of exiting the durability study (selected countries/ selected sites)
- •Female participants of childbearing potential (that is, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection
- •Participant willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including periodic weekly recordings by the participant using an electronic handheld device provided for this study
- •Understand and sign an informed consent form (ICF) before any investigational procedure(s) are performed
排除标准
- •Participants who, during their participation in a prior nemolizumab study, experienced an adverse event (AE) which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the participant
- •Body weight < 30 kg
- •Pregnant women (positive pregnancy test result at screening or baseline visit or re-entry Week R0 visit), breastfeeding women, or women planning a pregnancy during the clinical study
- •Any medical or psychological condition that may put the participant at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (example, poor venous access or needle-phobia)
- •Planning or expected to have a major surgical procedure during the clinical study
- •Participants unwilling to refrain from using prohibited medications during the clinical study
- •History of alcohol or substance abuse within 6 months prior to the screening visit or re-entry Week R0 visit
研究组 & 干预措施
Nemolizumab
Experimental
Participants weighing less than (<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.
干预措施: Nemolizumab (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs) by Severity
时间窗: Up to 192 weeks
Incidence of AEs including AEs of Special Interest (AESIs), Treatment Emergent AEs (TEAEs) and Serious AEs (SAEs) by severity as mild, moderate or severe will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with relevant investigational product. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. TEAE is an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.
次要结局
- Percentage of Participants with an Investigator Global Assessment (IGA) Success up to Week 184(Up to Week 184)
- Percentage of Participants with an Improvement of >=4 from Baseline in Peak Pruritus (PP) Numeric Rating Scale (NRS) up to Week 184(Baseline up to Week 184)
- Percentage of Participants with Low Disease Activity State up to Week 184(Up to Week 184)
- Percentage of Pruriginous Lesions with Excoriations/Crusts up (PAS item 5a) up to Week 184(Up to Week 184)
- Percentage of Healed Prurigo Lesions (PAS item 5b) up to Week 184(Up to Week 184)
- Change from Baseline in Number of Lesions in Representative Area (PAS item 4) up to Week 184(Baseline up to Week 184)
- Percentage of Participants with PP NRS <2 up to Week 184(Up to Week 184)
- Percent Change from Baseline in PP NRS up to Week 184(Baseline up to Week 184)
- Absolute Change from Baseline in PP NRS up to Week 184(Baseline up to Week 184)
- Percentage of Participants with Average Pruritus (AP) NRS <2 up to Week 52(Up to Week 52)
- Percentage of Participants with an Improvement of >=4 from Baseline in AP NRS up to Week 52(Up to Week 52)
- Percent Change from Baseline in AP NRS up to Week 52(Up to Week 52)
- Absolute Change from Baseline in AP NRS up to Week 52(Up to Week 52)
- Percentage of Participants with an Improvement of >=4 from Baseline in Sleep Disturbance (SD) NRS up to Week 184(Up to Week 184)
- Percent Change from Baseline in SD NRS up to Week 184(Up to Week 184)
- Absolute Change from Baseline in SD NRS up to Week 184(Up to Week 184)
- Percentage of Participants Satisfied with Study Treatment Based on Patient Global Assessment of Treatment (PGAT) up to Week 52(Up to Week 52)
- Change from Baseline in Prurigo Nodularis (PN)-associated Pain Frequency up to Week 184(Baseline up to Week 184)
- Change from Baseline in PN-associated Pain Intensity up to Week 184(Baseline up to Week 184)
- Percentage of Participants Reporting low Disease Activity Based on Patient Global Assessment of Disease (PGAD) up to Week 52(Up to Week 52)
- Percentage of Participants with a Change of >=4 from Baseline in Dermatology Life Quality Index (DLQI) up to Week 184(Baseline up to Week 184)
- Change from Baseline in EuroQoL 5-Dimension (EQ-5D) up to Week 184(Baseline up to Week 184)
- Time to Permanent Study Drug Discontinuation(Baseline to 184 weeks)
- Time to Rescue Therapy(Baseline to 184 weeks)
- Percentage of Participants Receiving Any Rescue Treatment by Rescue Treatment(Baseline up to 184 weeks)
研究者
研究点 (4)
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