Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis

NCT ID: NCT06099704

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2026-04-10

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.

Conditions

Moderate to Severe Atopic Dermatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with msAD

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)

No interventions assigned to this group

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number : 1240019

Calgary, Alberta, Canada

Investigational Site Number : 1240021

Calgary, Alberta, Canada

Investigational Site Number : 1240009

Edmonton, Alberta, Canada

Investigational Site Number : 1240007

Edmonton, Alberta, Canada

Investigational Site Number : 1240028

Nanaimo, British Columbia, Canada

Investigational Site Number : 1240010

Surrey, British Columbia, Canada

Investigational Site Number : 1240029

Winnipeg, Manitoba, Canada

Investigational Site Number : 1240026

Fredericton, New Brunswick, Canada

Investigational Site Number : 1240020

Halifax, Nova Scotia, Canada

Investigational Site Number : 1240002

Ajax, Ontario, Canada

Investigational Site Number : 1240024

Barrie, Ontario, Canada

Investigational Site Number : 1240031

Cobourg, Ontario, Canada

Investigational Site Number : 1240011

Etobicoke, Ontario, Canada

Investigational Site Number : 1240016

London, Ontario, Canada

Investigational Site Number : 1240025

Newmarket, Ontario, Canada

Investigational Site Number : 1240008

Peterborough, Ontario, Canada

Investigational Site Number : 1240005

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240033

Toronto, Ontario, Canada

Investigational Site Number : 1240030

Toronto, Ontario, Canada

Investigational Site Number : 1240014

Toronto, Ontario, Canada

Investigational Site Number : 1240018

Waterloo, Ontario, Canada

Investigational Site Number : 1240034

Whitby, Ontario, Canada

Investigational Site Number : 1240012

Montreal, Quebec, Canada

Investigational Site Number : 1240017

Montreal, Quebec, Canada

Investigational Site Number : 1240006

Pointe-Claire, Quebec, Canada

Investigational Site Number : 1240013

Québec, Quebec, Canada

Investigational Site Number : 1240023

Saint-Jean-sur-Richelieu, Quebec, Canada

Investigational Site Number : 1240003

Regina, Saskatchewan, Canada

Investigational Site Number : 1240027

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

U1111-1288-8240

Identifier Type: OTHER

Identifier Source: secondary_id

OBS17843

Identifier Type: -

Identifier Source: org_study_id