Clinical trial NCT05214326: 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
Official title: A Real-World Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Patients Receiving Dupilumab Therapy, With Atopic Dermatitis Control Tool in Gulf Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 187
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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) 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: 24 weeks

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)
timeFrame: At week 24
Secondary outcomes:
measure: Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT
timeFrame: At weeks 4, 12, and 24
measure: Percentages (%) of patients with ADCT score less than 7
timeFrame: At weeks 4 and 12
measure: Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)
timeFrame: At week 24
measure: Mean change in SCORAD
timeFrame: From baseline (week 0) to week 24
measure: Number of patients with at least one type-2 inflammation comorbidity
timeFrame: Baseline (week 0) to week 24
measure: Adverse events (AEs) related to dupilumab use
timeFrame: Baseline (week 0) to week 24
measure: Serious adverse events (SAEs) related to dupilumab use
timeFrame: Baseline (week 0) to week 24
measure: Adverse events of special interest (AESI) related to dupilumab use
timeFrame: Baseline (week 0) to week 24
measure: Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI
timeFrame: Baseline (week 0) to week 24
measure: Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good
timeFrame: At week 24
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Investigational site Kuwait
city: Saudi Arabia
country: Saudi Arabia
facility: Investigational site Saudi Arabia
city: United Arab Emirates
country: United Arab Emirates
facility: Investigational site United Arab Emirates
Study officials:
affiliation: Sanofi
name: Trial Transparency Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: