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

NCT06099704 | Active Not Recruiting

• 2 other identifiers: OBS17843U1111-1288-8240
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 29

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.

Conditions

Moderate to Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• Percentage of participants achieving a reduction in Eczema Area and Severity Index (EASI) of at least 75% at 6 months

  EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.

  Month 6

• Percentage of participants achieving a reduction in EASI of at least 75% at 12 months

  EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.

  Month 12

• Percentage of participants achieving a reduction in EASI of at least 75% at 18 months

  EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics \[erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification\] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.

  Month 18

Secondary Outcomes (35)

• Change from baseline in EASI score

  From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation

• Change from baseline in Body Surface Area of Atopic Dermatitis Involvement (BSA) score

  From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation

• Change from baseline in Hospital Anxiety and Depression Scale (HADS) score

  From baseline to 6 months, 12 months, 18 months post-Dupixent initiation

• Change from baseline in Skin pain/soreness numerical rating scale (NRS)

  From baseline to 6 months, 12 months, 18 months post-Dupixent initiation

• Change from baseline in skin feeling hot or burning NRS

  From baseline to 6 months, 12 months, 18 months post-Dupixent initiation

Study Arms (1)

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)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (29)

Investigational Site Number : 1240019

Calgary, Alberta, T2J 7E1, Canada

Location

Investigational Site Number : 1240021

Calgary, Alberta, T3B 6A9, Canada

Location

Investigational Site Number : 1240009

Edmonton, Alberta, T5J 3S9, Canada

Location

Investigational Site Number : 1240007

Edmonton, Alberta, T5K 2V4, Canada

Location

Investigational Site Number : 1240028

Nanaimo, British Columbia, V9T 1W1, Canada

Location

Investigational Site Number : 1240010

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigational Site Number : 1240029

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Investigational Site Number : 1240026

Fredericton, New Brunswick, R3M 3Z4, Canada

Location

Investigational Site Number : 1240020

Halifax, Nova Scotia, B3H 4R2, Canada

Location

Investigational Site Number : 1240002

Ajax, Ontario, L1S 7K8, Canada

Location

Investigational Site Number : 1240024

Barrie, Ontario, L4M 7G1, Canada

Location

Investigational Site Number : 1240031

Cobourg, Ontario, K9A 0Z4, Canada

Location

Investigational Site Number : 1240011

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Investigational Site Number : 1240016

London, Ontario, N6A 5R9, Canada

Location

Investigational Site Number : 1240025

Newmarket, Ontario, L3Y 5G8, Canada

Location

Investigational Site Number : 1240008

Peterborough, Ontario, K9J 5K2, Canada

Location

Investigational Site Number : 1240005

Richmond Hill, Ontario, L4E 4L6, Canada

Location

Investigational Site Number : 1240033

Toronto, Ontario, M3B 3N1, Canada

Location

Investigational Site Number : 1240030

Toronto, Ontario, M4E 1R7, Canada

Location

Investigational Site Number : 1240014

Toronto, Ontario, M5G 1X8, Canada

Location

Investigational Site Number : 1240018

Waterloo, Ontario, N2J 1C4, Canada

Location

Investigational Site Number : 1240034

Whitby, Ontario, L1N 8M7, Canada

Location

Investigational Site Number : 1240012

Montreal, Quebec, H3H 2R9, Canada

Location

Investigational Site Number : 1240017

Montreal, Quebec, H3T 1C5, Canada

Location

Investigational Site Number : 1240006

Pointe-Claire, Quebec, H9R 4Y2, Canada

Location

Investigational Site Number : 1240013

Québec, Quebec, G1W 4R4, Canada

Location

Investigational Site Number : 1240023

Saint-Jean-sur-Richelieu, Quebec, J3A 1B7, Canada

Location

Investigational Site Number : 1240003

Regina, Saskatchewan, S4V 1R9, Canada

Location

Investigational Site Number : 1240027

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 25, 2023
• Study Start: October 10, 2023
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (29)