Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study (GLOBOSPIN)

Sanofi

Status: Active, not recruiting

Conditions: Prurigo Nodularis

Treatments: Drug: Dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05991323

OBS17721

U1111-1288-8567 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

The follow-up period will be 18 months or until death, loss to follow-up, or withdrawal, whichever comes first.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patient with prurigo nodularis

Description:

Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study

Treatment:

Drug: Dupilumab