Clinical trial NCT06087627: A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prurigo Nodularis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants ≥ 18 years suffering from moderate-to-severe PN who receive long-term dupilumab treatment for PN in a real-world setting in Germany.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage (%) of participants with Investigator Global Assessment Prurigo Nodularis Stage (IGA-CPG-S) score 0 or 1 in Month 6
timeFrame: Month 6
measure: 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
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Characterization of the participants who receive dupilumab for PN: Socio-demographic data
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Medical history of disease
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Previous PN treatment (including balneophototherapy and/or UV therapy)
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Current PN treatment (INN, topical and/or systemic)
timeFrame: Baseline, Months 1, 3, 6, 9, 12, 18 and 24
measure: Characterization of the participants who receive dupilumab for PN: Concomitant medication (INN)
timeFrame: Baseline, Months 1, 3, 6, 12 and 24
measure: Characterization of the participants who receive dupilumab for PN: Presence of relevant comorbidities or of other prurigo subtypes
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Biomarker levels (if available)
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Laboratory results (if available)
timeFrame: Baseline
measure: Characterization of the participants who receive dupilumab for PN: Reasons for initiation of dupilumab treatment
timeFrame: Baseline
measure: 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
timeFrame: Months 1, 3, 6, 12 and 24
measure: Effectiveness of dupilumab: Change in Prurigo Control Test (PCT) from baseline to month 6, month 12, and month 24 after initiation of dupilumab therapy
timeFrame: Baseline to Months 6, 12 and 24
measure: 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
timeFrame: Baseline to Months 3, 6, 9, 12, 18 and 24
measure: 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
timeFrame: Baseline to Months 6, 9, 12, 18 and 24
measure: 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
timeFrame: Baseline to Months 1, 3, 9, 12, 18 and 24
measure: 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
timeFrame: Months 1, 3, 6, 9, 12, 18 and 24
measure: 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
timeFrame: Months 1, 3, 9, 12, 18 and 24
measure: 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
timeFrame: Months 6, 12 and 24
measure: 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
timeFrame: Baseline to Months 6, 12 and 24
measure: 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
timeFrame: Baseline to Months 3, 6, 12 and 24
measure: 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
timeFrame: Baseline, Month 1, 3, 6, 12 and 24
measure: Effectiveness of dupilumab: Number and duration of hospitalization due to PN during the last 12 months after 12 and 24 months of dupilumab therapy
timeFrame: Baseline to Month 12 and Month 24
measure: Pharmacodynamics of dupilumab: Pharmacodynamic response for selected biomarkers (total IgE, blood eosinophils) at month 12 and month 24 after initiation of dupilumab therapy
timeFrame: Month 12, Month 24
measure: Treatment patterns during real-world use of dupilumab: Dupilumab dose regimens used over the study, and the duration with each regimen
timeFrame: Baseline to Month 24
measure: 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
timeFrame: Baseline to Month 24
measure: 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
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Percentage of participants discontinuing dupilumab, including temporary or permanent discontinuation
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Type of treatment switched to after discontinuing dupilumab
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Duration of use, drug survival of dupilumab
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment and longest gap length
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Concomitant therapies taken for PN
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Reason for switching or discontinuing dupilumab
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Time from baseline to self-administer dupilumab at home
timeFrame: Baseline to Month 24
measure: Safety: Occurrence and type of Treatment-Emergent Adverse Events (TEAEs) during the observational period
timeFrame: Baseline to Month 24
measure: Safety: Occurrence and type of dupilumab-related TEAEs during the observational period
timeFrame: Baseline to Month 24
measure: Safety: Event rate (per patient year) by type of TEAEs during the observational period
timeFrame: Baseline to Month 24
measure: Safety: Event rate (per patient year) by type of dupilumab-related TEAEs during the observational period
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Number of gaps in dupilumab treatment
timeFrame: Baseline to Month 24
measure: Treatment patterns during real-world use of dupilumab: Longest gap length in dupilumab treatment
timeFrame: Baseline to Month 24
Other outcomes:
Locations:
city: Adernach
country: Germany
facility: Investigational Site Number: 013
city: Berlin
country: Germany
facility: Investigational site number: 001
city: Berlin
country: Germany
facility: Investigational Site Number: 002
city: Chemnitz
country: Germany
facility: Investigational Site Number: 023
city: Düren
country: Germany
facility: Investigational Site Number: 005
city: Düsseldorf
country: Germany
facility: Investigational Site Number: 004
city: Hamburg
country: Germany
facility: Investigational Site Number: 007
city: Leipzig
country: Germany
facility: Investigational Site Number: 016
city: Mainz
country: Germany
facility: Investigational Site Number: 031
city: Potsdam
country: Germany
facility: Investigational Site Number: 022
city: Potsdam
country: Germany
facility: Investigational Site Number: 024
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: