Clinical trial NCT05991323: Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study
Official title: A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prurigo Nodularis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-08-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants who initiate dupilumab treatment for prurigo nodularis (according to the country-specific prescribing information)

Brief summary: 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.

Detailed description: The follow-up period will be 36 months or until death, loss to follow-up, or withdrawal, whichever comes first.

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.

Primary outcomes:
measure: Frequency of reasons for dupilumab treatment initiation with the description of dosing, frequency and duration of treatment
timeFrame: At baseline
measure: Frequency of reasons for dupilumab treatment modifications with the description of the modified treatment
timeFrame: From baseline up to month 36
measure: Proportion of patients who discontinued dupilumab
timeFrame: From baseline up to month 36
measure: Frequency of reasons for dupilumab treatment discontinuation
timeFrame: From baseline up to month 36
measure: Proportion of patients hospitalized due to PN
timeFrame: From baseline up to month 36
Secondary outcomes:
measure: Baseline Characteristics: PN-related medical history
timeFrame: At baseline
measure: Baseline Characteristics: Socio-demographics of PN patients
timeFrame: At baseline
measure: Baseline Characteristics: Type of PN therapies received prior to initiation of dupilumab treatment
timeFrame: At baseline
measure: Proportion of patients using concomitant medication
timeFrame: At baseline
measure: Proportion of patients with a ≥ four-point improvement (reduction) in Worst Itch Numeric Rating Scale (WI-NRS)
timeFrame: From baseline up to month 36
measure: Mean change in WI-NRS
timeFrame: From baseline up to month 36
measure: Proportion of patients with a ≥ four-point improvement (reduction) in Skin Pain Numeric Rating Scale (NRS)
timeFrame: From baseline up to month 36
measure: Mean change in Skin Pain NRS
timeFrame: From baseline up to month 36
measure: Proportion of patients with a ≥ two-point improvement (reduction) in Sleep Disturbance Numeric Rating Scale (NRS)
timeFrame: From baseline up to month 36
measure: Mean change in Sleep Disturbance NRS
timeFrame: From baseline up to month 36
measure: Proportion of patients with Patient Global Impression of Change of PN Disease (PGIC) score of "Very much better (improved)"
timeFrame: From baseline up to month 36
measure: Proportion of patients with PGIC score of "Very much better (improved)" or "Moderately better (improved)"
timeFrame: From baseline up to month 36
measure: Mean change in PGIC
timeFrame: From baseline up to month 36
measure: Proportion of patients with Patient Global Impression of Severity of PN Disease (PGIS) score of "None"
timeFrame: From baseline up to month 36
measure: Proportion of patients with PGIS score of "None" or "Mild"
timeFrame: From baseline up to month 36
measure: Mean change in PGIS
timeFrame: From baseline up to month 36
measure: Mean change in Dermatology Life Quality Index (DLQI)
timeFrame: From baseline up to month 36
measure: Mean change in Pruritus Activity Score (PAS)
timeFrame: From baseline up to month 36
measure: Proportion of patients with Investigator's Global Assessment-chronic prurigo Activity (IGA-CPG Activity) score of 0 or 1
timeFrame: From baseline up to month 36
measure: Mean change in IGA-CPG Activity
timeFrame: From baseline up to month 36
measure: Proportion of patients with Investigator's Global Assessment-chronic prurigo Stage (IGA-CPG Stage) score of 0 or 1
timeFrame: From baseline up to month 36
measure: Mean change in IGA-CPG Stage
timeFrame: From baseline up to month 36
measure: Mean change in EQ-5D-5L
timeFrame: From baseline up to month 36
measure: Mean change in Hospital Anxiety and Depression Scale (HADS) total score
timeFrame: From baseline up to month 36
measure: Proportion of patients reported working, absenteeism score, presenteeism score, and overall impairment working score using the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: From baseline up to month 36
measure: Percentage of patients experiencing AEs and SAEs
timeFrame: From baseline up to month 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Site Number : 8400005
state: Arizona
city: Phoenix
country: United States
facility: Saguaro Dermatology Associates, LLC - Probity - PPDS- Site Number : 8400024
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8400002
state: California
city: Laguna Hills
country: United States
facility: Halcyon Dermatology- Site Number : 8400023
state: California
city: Rancho Santa Margarita
country: United States
facility: Mission Dermatology - Rancho Santa Margarita- Site Number : 8400015
state: California
city: Walnut Creek
country: United States
facility: Golden State Dermatology- Site Number : 8400014
state: California
city: Boynton Beach
country: United States
facility: Total Vein And Skin, LLC- Site Number : 8400019
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research- Site Number : 8400017
state: Florida
city: Columbus
country: United States
facility: Allergy Center at Brookstone Research - Centricity Research - PPDS- Site Number : 8400025
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave- Site Number : 8400003
state: Indiana
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology - 3400 Auburn Rd- Site Number : 8400007
state: Michigan
city: Caledonia
country: United States
facility: Derm Institute of Western Michigan- Site Number : 8400034
state: Michigan
city: Grand Rapids
country: United States
facility: Dermatology Associates Western Michigan- Site Number : 8400033
state: Michigan
city: Lee's Summit
country: United States
facility: U.S. Dermatology Partners Lee's Summit- Site Number : 8400016
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska - Lauritzen Outpatient Center- Site Number : 8400029
state: Nebraska
city: Las Vegas
country: United States
facility: Vivida Dermatology - Flamingo- Site Number : 8400013
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Dermatology- Site Number : 8400027
state: Nevada
city: Durham
country: United States
facility: Duke Dermatology Clinic- Site Number : 8400026
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC) - PPDS- Site Number : 8400001
state: South Carolina
city: Frisco
country: United States
facility: North Texas Center for Clinical Research- Site Number : 8400012
state: Texas
city: Longview
country: United States
facility: U.S. Dermatology Partners Longview- Site Number : 8400032
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center-125 W Hague Rd- Site Number : 8400010
state: Texas
city: Morgantown
country: United States
facility: West Virginia Research Institute- Site Number : 8400030
state: West Virginia
city: Calgary
country: Canada
facility: Investigational Site Number : 1240009
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240007
state: Alberta
city: Surrey
country: Canada
facility: Investigational Site Number : 1240012
state: British Columbia
city: Fredericton
country: Canada
facility: Investigational Site Number : 1240006
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational Site Number : 1240004
state: Ontario
city: Barrie
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240011
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240005
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1240010
state: Ontario
city: Guangzhou
country: China
facility: Investigational Site Number : 1560009
state: Guangdong
city: Xi'an
country: China
facility: Investigational Site Number : 1560004
state: Shaanxi
city: Jinan
country: China
facility: Investigational Site Number : 1560003
state: Shandong
city: Hangzhou
country: China
facility: Investigational Site Number : 1560008
state: Zhejiang
city: Wenzhou
country: China
facility: Investigational Site Number : 1560010
state: Zhejiang
city: Beijing
country: China
facility: Investigational Site Number : 1560007
city: Beijing
country: China
facility: Investigational Site Number : 1560005
city: Shanghai
country: China
facility: Investigational Site Number : 1560006
city: Shenzhen
country: China
facility: Investigational Site Number : 1560002
city: Brest
country: France
facility: Investigational Site Number : 2500005
state: Finistère
city: Nantes
country: France
facility: Investigational Site Number : 2500001
city: Obihiro
country: Japan
facility: Investigational Site Number : 3920001
state: Hokkaido
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920003
city: Matsudo
country: Japan
facility: Investigational Site Number : 3920004
city: Bergen Op Zoom
country: Netherlands
facility: Investigational Site Number : 5280001
state: Noord-Brabant
city: Hoofddorp
country: Netherlands
facility: Investigational Site Number : 5280002
state: Noord-Holland
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: