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Clinical trial

A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis

ID
Name
OBS17721
Description
This study is a prospective, multinational, observational investigation designed to elucidate the real-world effectiveness and treatment patterns of dupilumab therapy in adult patients diagnosed with prurigo nodularis (PN). The primary objective of this study is to comprehensively characterize the real-world usage of dupilumab for the management of PN. In addition to this, the study aims to achieve several secondary objectives, including a detailed assessment of the medical history, socio-demographic and disease characteristics of dupilumab-treated PN patients, as well as the evaluation of the long-term real-world effectiveness of dupilumab therapy for PN.
Trial arms
Trial start
2023-12-12
Estimated PCD
2031-06-23
Trial end
2031-06-23
Status
Recruiting
Treatment
Dupilumab
Injection solution; subcutaneous
Arms:
Patient with prurigo nodularis
Other names:
DUPIXENT, SAR231893
Size
550
Primary endpoint
Frequency of reasons for dupilumab treatment initiation with the description of dosing
At baseline
Duration of dupilumab treatment
At baseline and in 60 months
Percentage of patients having dupilumab treatment modifications
From baseline up to month 60
Frequency of reasons for dupilumab treatment modifications
From baseline up to month 60
Proportion of patients who discontinued dupilumab
From baseline up to month 60
Frequency of reasons for dupilumab treatment discontinuation
From baseline up to month 60
Proportion of patients hospitalized due to PN
From baseline up to month 60
Eligibility criteria
Inclusion Criteria: * Patients aged 18 years or older at the time of informed consent. * Physician decision to treat the patient with dupilumab for prurigo nodularis (according to the country-specific prescribing information) made prior to and independently of the patient's participation in the study. * Patients able to understand and complete study-related questionnaires. * Patients provide voluntary informed consent to participate in the study before inclusion in the study. Exclusion Criteria: * Patients who have a contraindication to dupilumab according to the country-specific prescribing information label. * Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of visits and assessments. * Patients currently participating in any interventional clinical trial. * Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 550, 'type': 'ESTIMATED'}}
Updated at
2024-02-29

1 organization

1 product

1 indication

Organization
Sanofi
Product
Dupilumab
Indication
Prurigo Nodularis