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

Sanofi3 sites in 3 countries187 target enrollmentJanuary 18, 2022

ConditionsDermatitis Atopic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dermatitis Atopic
Sponsor: Sanofi
Enrollment: 187
Locations: 3
Primary Endpoint: Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 18, 2022

End Date

March 21, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

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
•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 ≥
•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.

Outcomes

Primary Outcomes

Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)

Time Frame: At week 24

ADCT is a questionnaire to assess patient-self-perceived control of their atopic dermatitis (AD) with a total score from 0 to 24; higher scores indicate lower AD control.

Secondary Outcomes

Percentages (%) of patients with ADCT score less than 7(At weeks 4 and 12)
Number of patients with at least one type-2 inflammation comorbidity(Baseline (week 0) to week 24)
Adverse events of special interest (AESI) related to dupilumab use(Baseline (week 0) to week 24)
Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good(At week 24)
Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT(At weeks 4, 12, and 24)
Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)(At week 24)
Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI(Baseline (week 0) to week 24)
Mean change in SCORAD(From baseline (week 0) to week 24)
Adverse events (AEs) related to dupilumab use(Baseline (week 0) to week 24)
Serious adverse events (SAEs) related to dupilumab use(Baseline (week 0) to week 24)