Prospective, Non-interventional Observational Study to Characterize Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 110
- 试验地点
- 11
- 主要终点
- Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in Month 6
研究概览
简要总结
Prurigo nodularis (PN) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. The main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. In recent years, number of studies evaluating PN, the affected population and the disease burden has increased but PN remains still understudied. This non-interventional study is intended to describe the long-term effectiveness of dupilumab (Dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe PN who receive dupilumab for PN treatment in a real-world setting in Germany according to the prescribing information (Summary of Product Characteristics [SmPC]). The decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. This decision is made independently and before data inclusion in this non-interventional study.
详细描述
The individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year after dupilumab initiation, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 at least 18 years of age at baseline visit
- •Signed written informed consent
- •New initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/Summary of Product Characteristics (SmPC)
- •Patients who received the initial diagnosis of PN
排除标准
- •Patients who have a contraindication to dupilumab according to the current prescribing information label/SmPC
- •Patients who have been treated for more than 7 days with dupilumab
- •Any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results
- •Participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
PN treatment
Participants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.
干预措施: Dupilumab SAR231893 (REGN668) (Drug)
结局指标
主要结局
Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in Month 6
时间窗: Month 6
IGA CPG-S is an instrument used to assess the overall number and thickness of PN lesions at a given time point, as determined by the investigator. It consists of a 5-point scale ranging from 0 to 4 where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. Higher scores indicate severe prurigo nodularis (PN).
Percentage (%) of participants with greater than or equal to (≥) 4-point improvement (reduction) in Worst Itch Numerical Rating Scale (WI-NRS) from baseline to Month 6
时间窗: Baseline, Month 6
WI-NRS is a validated measure of itch severity. 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
- Characterization of the participants who receive dupilumab for PN: Socio-demographic data(Baseline)
- Characterization of the participants who receive dupilumab for PN: Medical history of disease(Baseline)
- Characterization of the participants who receive dupilumab for PN: Previous PN treatment (including balneophototherapy and/or UV therapy)(Baseline)
- Characterization of the participants who receive dupilumab for PN: Current PN treatment (INN, topical and/or systemic)(Baseline, Months 1, 3, 6, 9, 12, 18 and 24)
- Characterization of the participants who receive dupilumab for PN: Concomitant medication (INN)(Baseline, Months 1, 3, 6, 12 and 24)
- Characterization of the participants who receive dupilumab for PN: Presence of relevant comorbidities or of other prurigo subtypes(Baseline)
- Effectiveness of dupilumab: Change in Prurigo Control Test (PCT) from baseline to month 6, month 12, and month 24 after initiation of dupilumab therapy(Baseline to Months 6, 12 and 24)
- Effectiveness of dupilumab: Change in Dermatology Life Quality Index (DLQI) from baseline to month 3, month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy(Baseline to Months 3, 6, 9, 12, 18 and 24)
- Effectiveness of dupilumab: Change in Sleep Numerical Rating Scale (Sleep-NRS) from baseline to month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy(Baseline to Months 6, 9, 12, 18 and 24)
- Effectiveness of dupilumab: Percentage (%) of participants with ≥ 4-point improvement (reduction) in WI-NRS from baseline to month 1, month 3, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy(Baseline to Months 1, 3, 9, 12, 18 and 24)
- Effectiveness of dupilumab: Percentage (%) of participants with IGA-CPG activity (IGA-CPG-A) score of 0 or 1 at month 1, month 3, month 6, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy(Months 1, 3, 6, 9, 12, 18 and 24)
- Effectiveness of dupilumab: Percentage (%) of participants with IGA-CPG-S score of 0 or 1 in month 1, month 3, month 9, month 12, month 18, and month 24 after initiation of dupilumab therapy(Months 1, 3, 9, 12, 18 and 24)
- Effectiveness of dupilumab: Percentage (%) of participants with Patient Benefit Index-Pruritus (PBI-P) ≥ 1 at month 6, month 12, and month 24 of dupilumab therapy(Months 6, 12 and 24)
- Effectiveness of dupilumab: Change in Hospital Depression and Anxiety Score (HADS total score) from baseline to month 6, month 12, and month 24 of dupilumab therapy(Baseline to Months 6, 12 and 24)
- Effectiveness of dupilumab: Percentage of participants who achieve ≥ 75% healed lesions from Prurigo Activity Score (PAS) from baseline to month 3, month 6, month 12, and month 24 of dupilumab therapy(Baseline to Months 3, 6, 12 and 24)
- Treatment patterns during real-world use of dupilumab: Percentage of participants whose dose (either the frequency or the strength) increased from starting regimen and reasons(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Percentage of participants whose dose (either the frequency or the strength) decreased from the starting regimen and reasons(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Percentage of participants discontinuing dupilumab, including temporary or permanent discontinuation(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Type of treatment switched to after discontinuing dupilumab(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Duration of use, drug survival of dupilumab(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment and longest gap length(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Concomitant therapies taken for PN(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Reason for switching or discontinuing dupilumab(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Time from baseline to self-administer dupilumab at home(Baseline to Month 24)
- Safety: Occurrence and type of Treatment-Emergent Adverse Events (TEAEs) during the observational period(Baseline to Month 24)
- Safety: Occurrence and type of dupilumab-related TEAEs during the observational period(Baseline to Month 24)
- Safety: Event rate (per patient year) by type of TEAEs during the observational period(Baseline to Month 24)
- Safety: Event rate (per patient year) by type of dupilumab-related TEAEs during the observational period(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment(Baseline to Month 24)
- Treatment patterns during real-world use of dupilumab: Longest gap length in dupilumab treatment(Baseline to Month 24)
- Characterization of the participants who receive dupilumab for PN: Biomarker levels (if available)(Baseline)
- Characterization of the participants who receive dupilumab for PN: Laboratory results (if available)(Baseline)
- Characterization of the participants who receive dupilumab for PN: Reasons for initiation of dupilumab treatment(Baseline)
- Effectiveness of dupilumab: Patient Global Impression of Change (PGIC) of PN disease at month 1, month 3, month 6, month 12, and month 24 of dupilumab therapy(Months 1, 3, 6, 12 and 24)
- Effectiveness of dupilumab: Number of sick-leave days at work due to PN during the last 12 months before baseline and since the last visit after starting dupilumab treatment(Baseline, Month 1, 3, 6, 12 and 24)
- Effectiveness of dupilumab: Number and duration of hospitalization due to PN during the last 12 months after 12 and 24 months of dupilumab therapy(Baseline to Month 12 and Month 24)
- Pharmacodynamics of dupilumab: Pharmacodynamic response for selected biomarkers (total IgE, blood eosinophils) at month 12 and month 24 after initiation of dupilumab therapy(Month 12, Month 24)
- Treatment patterns during real-world use of dupilumab: Dupilumab dose regimens used over the study, and the duration with each regimen(Baseline to Month 24)