Status:
COMPLETED
A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries
Lead Sponsor:
Sanofi
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
12+ years
Brief Summary
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)...
Detailed Description
24 weeks
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 21 2023
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT05214326
Start Date
January 18 2022
End Date
March 21 2023
Last Update
November 29 2023
Active Locations (3)
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1
Investigational site Kuwait
Kuwait City, Kuwait
2
Investigational site Saudi Arabia
Saudi Arabia, Saudi Arabia
3
Investigational site United Arab Emirates
United Arab Emirates, United Arab Emirates