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

Sanofi

Status: Active, not recruiting

Conditions: Moderate to Severe Atopic Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT06099704

OBS17843

U1111-1288-8240 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 305 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

305 participants in 1 patient group

Participants with msAD

Description:

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)