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

NCT05991323

Active Not RecruitingN/A

Sponsor: Sanofi

Conditions: Prurigo Nodularis

Interventions: Dupilumab

Countries: United States, Canada, China, France, Japan, Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (49)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Fremont, California, United States
  • Laguna Hills, California, United States
  • Rancho Santa Margarita, California, United States
  • Walnut Creek, California, United States
  • Boynton Beach, Florida, United States
  • Margate, Florida, United States
  • Columbus, Georgia, United States
  • Indianapolis, Indiana, United States
  • Auburn Hills, Michigan, United States
  • Caledonia, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Lee's Summit, Missouri, United States
  • Omaha, Nebraska, United States
  • Las Vegas, Nevada, United States
  • Las Vegas, Nevada, United States
  • Durham, North Carolina, United States
  • Charleston, South Carolina, United States
  • Frisco, Texas, United States
  • Longview, Texas, United States
  • Lubbock, Texas, United States
  • Morgantown, West Virginia, United States
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Surrey, British Columbia, Canada
  • Fredericton, New Brunswick, Canada
  • Ajax, Ontario, Canada
  • Barrie, Ontario, Canada
  • London, Ontario, Canada
  • + 19 more on CT.gov