Clinical trial NCT06099704: Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
Official title: A Prospective, Observational Study of Canadian Patients Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Moderate to Severe Atopic Dermatitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-10-25
Enrollment: 305
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Canadian msAD participants (ages 6+) who receive Dupixent for msAD according to the Canadian-country specific prescribing information (in accordance with the Canadian Dupixent Product Monograph)

Brief summary: This is a prospective, 18-month observational study of adult, adolescent and pediatric Canadian participants with Atopic Dermatitis (AD) commonly known as Eczema, who receive treatment with Dupixent for moderate-to-severe AD (msAD) according to the Canadian-specific prescribing information (in accordance with the Canadian Dupixent Product Monograph). The study will be conducted in approximately 30 centers in Canada to assess participants of all ethnicities and races. At each participating site, all AD participants who receive an initial prescription for Dupixent will be invited to participate in this study, until the Canadian enrollment goal is achieved.

Detailed description: The duration of the study for each participant will be of 18 months.

Eligibility criteria: Inclusion Criteria:

* Male or female, 6 years or older at baseline visit (Canada has received the country's regulatory approval for use of Dupixent treating msAD for these ages).
* Participant is initiating dupilumab as part of routine clinical care through the Dupixent Patient Support Program (PSP) for the treatment of msAD, as per reimbursement criteria. Decision to treat with dupilumab must have been reached prior to and independently of recruitment in the study.
* Have a physician's diagnosis of msAD.
* Provided signed informed consent or parental/legally acceptable representative consent and/or participant assent. During the study, subjects will continue to receive maintenance therapies for their AD as clinically indicated and as per usual medical practice.
* Participant or Parental representative able to understand English and/or Canadian French to complete study-related questionnaires.

Exclusion Criteria:

* Participants who have a contraindication to the drug according to the Canadian-specific prescribing information label.
* Any condition that, in the opinion of the Investigator, may interfere with participant'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 participant from adequately completing the schedule of visits and assessments.
* Participants currently participating in any interventional clinical trial which modifies participant care.
* Prior use of Dupixent within 6 months of the baseline visit.
* Participants not willing to sign the Informed Consent Form.

Primary outcomes:
measure: Percentage of participants achieving a reduction in Eczema Area and Severity Index (EASI) of at least 75% at 6 months
timeFrame: Month 6
measure: Percentage of participants achieving a reduction in EASI of at least 75% at 12 months
timeFrame: Month 12
measure: Percentage of participants achieving a reduction in EASI of at least 75% at 18 months
timeFrame: Month 18
Secondary outcomes:
measure: Change from baseline in EASI score
timeFrame: From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation
measure: Change from baseline in Body Surface Area of Atopic Dermatitis Involvement (BSA) score
timeFrame: From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation
measure: Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
measure: Change from baseline in Skin pain/soreness numerical rating scale (NRS)
timeFrame: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
measure: Change from baseline in skin feeling hot or burning NRS
timeFrame: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
measure: Change from baseline in Peak Pruritus NRS (PP-NRS)
timeFrame: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
measure: Percentage of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: From baseline up to 18 months post-Dupixent initiation
measure: Reasons for discontinuation of Dupixent therapy
timeFrame: From baseline up to 18 months post-Dupixent initiation
measure: Mean time to Dupixent discontinuation
timeFrame: From baseline up to 18 months post-Dupixent initiation
measure: Median time to Dupixent discontinuation
timeFrame: From baseline up to 18 months post-Dupixent initiation
measure: Percentage of participants who initiated Dupixent and remained on treatment
timeFrame: At 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Disease characteristics at baseline: EASI score
timeFrame: At baseline
measure: Disease characteristics at baseline: BSA score
timeFrame: At baseline
measure: Disease characteristics at baseline: Time between diagnosis and Dupixent prescription
timeFrame: At baseline
measure: Change from baseline in sleep Disturbance NRS scores post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in the dermatology life quality index (DLQI)/the Children's Dermatology Life Quality Index (CDLQI) scores post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) scores post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) scores post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in Dermatitis Family Impact (DFI) score post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Concomitant treatments received
timeFrame: From baseline up to 18 months
measure: Dupixent dosing regimen
timeFrame: From baseline up to 18 months
measure: Most commonly used Dupixent dosing regimens
timeFrame: From baseline up to 18 months
measure: Dupixent treatment duration
timeFrame: From baseline up to 18 months
measure: Number of gaps in Dupixent treatment
timeFrame: From baseline up to 18 months
measure: Longest gap in Dupixent treatment
timeFrame: From baseline up to 18 months
measure: Number of missed Dupixent doses over 18 months per participant
timeFrame: From baseline up to 18 months
measure: AD treatments to which participants switch when discontinuing dupixent
timeFrame: From baseline up to 18 months
measure: Reasons for initiation of new AD treatments
timeFrame: From baseline up to 18 months
measure: Reasons for discontinuation and/or switching AD treatments
timeFrame: From baseline up to 18 months
measure: Change from baseline in HADS
timeFrame: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in sleep disturbance NRS scores post-Dupixent initiation
timeFrame: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in height
timeFrame: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in weight
timeFrame: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
measure: Change from baseline in BMI
timeFrame: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
measure: Number of participants with demographic characteristics
timeFrame: From baseline up to 18 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Investigational Site Number : 1240019
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site Number : 1240021
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240009
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240007
state: Alberta
city: Nanaimo
country: Canada
facility: Investigational Site Number : 1240028
state: British Columbia
city: Surrey
country: Canada
facility: Investigational Site Number : 1240010
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240029
state: Manitoba
city: Fredericton
country: Canada
facility: Investigational Site Number : 1240026
state: New Brunswick
city: Halifax
country: Canada
facility: Investigational Site Number : 1240020
state: Nova Scotia
city: Ajax
country: Canada
facility: Investigational Site Number : 1240002
state: Ontario
city: Barrie
country: Canada
facility: Investigational Site Number : 1240024
state: Ontario
city: Cobourg
country: Canada
facility: Investigational Site Number : 1240031
state: Ontario
city: Etobicoke
country: Canada
facility: Investigational Site Number : 1240011
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240016
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site Number : 1240025
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240005
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240033
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240030
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240014
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Whitby
country: Canada
facility: Investigational Site Number : 1240034
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240012
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240017
state: Quebec
city: Pointe-claire
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240013
state: Quebec
city: Saint-jean-sur-richelieu
country: Canada
facility: Investigational Site Number : 1240023
state: Quebec
city: Regina
country: Canada
facility: Investigational Site Number : 1240003
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240027
state: Saskatchewan
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: