Primary objective:

To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.

Secondary objectives:

• To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.
• To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.
• Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).
• To describe comorbidities related to type 2 inflammation.
• To characterize the safety profile of dupilumab in the local Gulf population.
• To evaluate treatment satisfaction in the local Gulf population.

24 weeks

Inclusion Criteria:

• Having moderate to severe atopic dermatitis:

  • Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and 50.
  • Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥50.

• Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.

• Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.

• Age of 12 years or above.

Exclusion Criteria:

• Participation in another trial.
• Pregnancy or lactating or planning/intending to be pregnant in the next 6 months.
• Presence of active chronic or acute infection requiring systemic treatment
• Diagnosed active endoparasites infection, or suspected high risk of infection.
• Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Participants with moderate to severe atopic dermatitis, initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org