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

Last updated: March 17, 2025
Sponsor: Sanofi
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Allergy

Hives (Urticaria)

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT06099704
OBS17843
U1111-1288-8240
  • Ages > 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, 6 years or older at baseline visit (Canada has received thecountry's regulatory approval for use of Dupixent treating msAD for these ages).

  • Participant is initiating dupilumab as part of routine clinical care through theDupixent Patient Support Program (PSP) for the treatment of msAD, as perreimbursement criteria. Decision to treat with dupilumab must have been reachedprior to and independently of recruitment in the study.

  • Have a physician's diagnosis of msAD.

  • Provided signed informed consent or parental/legally acceptable representativeconsent and/or participant assent. During the study, subjects will continue toreceive maintenance therapies for their AD as clinically indicated and as per usualmedical practice.

  • Participant or Parental representative able to understand English and/or CanadianFrench to complete study-related questionnaires.

Exclusion

Exclusion Criteria:

  • Participants who have a contraindication to the drug according to theCanadian-specific prescribing information label.

  • Any condition that, in the opinion of the Investigator, may interfere withparticipant's ability to participate in the study, such as short life expectancy,substance abuse, severe cognitive impairment, or other comorbidities that canpredictably prevent the participant from adequately completing the schedule ofvisits and assessments.

  • Participants currently participating in any interventional clinical trial whichmodifies participant care.

  • Prior use of Dupixent within 6 months of the baseline visit.

  • Participants not willing to sign the Informed Consent Form.

Study Design

Total Participants: 305
Study Start date:
October 10, 2023
Estimated Completion Date:
April 10, 2026

Study Description

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

Connect with a study center

  • Investigational Site Number : 1240019

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Investigational Site Number : 1240021

    Calgary, Alberta T3B 6A9
    Canada

    Site Not Available

  • Investigational Site Number : 1240007

    Edmonton, Alberta T5K 2V4
    Canada

    Site Not Available

  • Investigational Site Number : 1240009

    Edmonton, Alberta T5J 3S9
    Canada

    Site Not Available

  • Investigational Site Number : 1240028

    Nanaimo, British Columbia V9T 1W1
    Canada

    Site Not Available

  • Investigational Site Number : 1240010

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Investigational Site Number : 1240029

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Investigational Site Number : 1240026

    Fredericton, New Brunswick R3M 3Z4
    Canada

    Site Not Available

  • Investigational Site Number : 1240020

    Halifax, Nova Scotia B3H 4R2
    Canada

    Site Not Available

  • Investigational Site Number : 1240002

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Investigational Site Number : 1240024

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Investigational Site Number : 1240031

    Cobourg, Ontario K9A 0Z4
    Canada

    Site Not Available

  • Investigational Site Number : 1240011

    Etobicoke, Ontario M8X 1Y9
    Canada

    Site Not Available

  • Investigational Site Number : 1240016

    London, Ontario N6A 5R9
    Canada

    Site Not Available

  • Investigational Site Number : 1240025

    Newmarket, Ontario L3Y 5G8
    Canada

    Site Not Available

  • Investigational Site Number : 1240008

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Investigational Site Number : 1240005

    Richmond Hill, Ontario L4E 4L6
    Canada

    Site Not Available

  • Investigational Site Number 1240015

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240014

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Investigational Site Number : 1240030

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • Investigational Site Number : 1240033

    Toronto, Ontario M3B 3N1
    Canada

    Site Not Available

  • Investigational Site Number : 1240018

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Investigational Site Number : 1240034

    Whitby, Ontario L1N 8M7
    Canada

    Site Not Available

  • Investigational Site Number : 1240006

    Dorval, Quebec H9P 2N4
    Canada

    Site Not Available

  • Investigational Site Number : 1240012

    Montreal, Quebec H3H 2R9
    Canada

    Site Not Available

  • Investigational Site Number : 1240017

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Investigational Site Number : 1240006

    Pointe-Claire, Quebec H9R 5M7
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240006

    Pointe-claire, Quebec H9R 4Y2
    Canada

    Site Not Available

  • Investigational Site Number : 1240013

    Québec City, Quebec G1W 4R4
    Canada

    Site Not Available

  • Investigational Site Number : 1240023

    Saint-Jean-sur-Richelieu, Quebec J3A 1B5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240023

    Saint-jean-sur-richelieu, Quebec J3A 1B7
    Canada

    Site Not Available

  • Investigational Site Number 1240003

    Regina, Saskatchewan S4V 1R9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240003

    Regina, Saskatchewan S4V 1R9
    Canada

    Site Not Available

  • Investigational Site Number : 1240027

    Saskatoon, Saskatchewan S7K 0H6
    Canada

    Site Not Available

  • Investigational Site Number : 1240013

    Quebec, G1W 4R4
    Canada

    Site Not Available

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