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
NCT ID: NCT05214326
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2022-01-18
2023-03-21
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with moderate to severe atopic dermatitis
Participants initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Trial Transparency Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational site Kuwait
Kuwait City, , Kuwait
Investigational site Saudi Arabia
Saudi Arabia, , Saudi Arabia
Investigational site United Arab Emirates
United Arab Emirates, , United Arab Emirates
Countries
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Other Identifiers
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U1111-1269-6618
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS17399
Identifier Type: OTHER
Identifier Source: secondary_id
OBS17399
Identifier Type: -
Identifier Source: org_study_id