Status:
ACTIVE_NOT_RECRUITING
Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Moderate to Severe Atopic Dermatitis
Eligibility:
All Genders
6+ years
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 f...
Detailed Description
The duration of the study for each participant will be of 18 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 10 2026
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT06099704
Start Date
October 10 2023
End Date
April 10 2026
Last Update
March 18 2025
Active Locations (29)
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1
Investigational Site Number : 1240019
Calgary, Alberta, Canada, T2J 7E1
2
Investigational Site Number : 1240021
Calgary, Alberta, Canada, T3B 6A9
3
Investigational Site Number : 1240009
Edmonton, Alberta, Canada, T5J 3S9
4
Investigational Site Number : 1240007
Edmonton, Alberta, Canada, T5K 2V4