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 (AD-impaCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis Atopic

Detailed Description

24 weeks

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Investigational site Kuwait
• Saudi Arabia
  • Saudi Arabia, Saudi Arabia
    • Investigational site Saudi Arabia
• United Arab Emirates
  • United Arab Emirates, United Arab Emirates
    • Investigational site United Arab Emirates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)	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.	At week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT	ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.	At weeks 4, 12, and 24
Percentages (%) of patients with ADCT score less than 7	ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.	At weeks 4 and 12
Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)	SCORAD is used to assess the extent and severity of AD. Extent and severity of AD as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).	At week 24
Mean change in SCORAD	SCORAD is used to assess the extent and severity of AD. Extent and severity of AD as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease).	From baseline (week 0) to week 24
Number of patients with at least one type-2 inflammation comorbidity	Comorbidities related to type-2 inflammation as (allergic rhinitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis).	Baseline (week 0) to week 24
Adverse events (AEs) related to dupilumab use	Number of patients experiencing adverse events (AEs) related to dupilumab use.	Baseline (week 0) to week 24
Serious adverse events (SAEs) related to dupilumab use	Number of patients experiencing serious adverse events (SAEs) related to dupilumab use.	Baseline (week 0) to week 24
Adverse events of special interest (AESI) related to dupilumab use	Number of patients experiencing adverse events of special interest (AESI) related to dupilumab use. An AESI is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is required.	Baseline (week 0) to week 24
Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI	Number of patients experiencing treatment interruption due to any adverse drug reaction, AE, SAE, or AESI. An AESI is an adverse event (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is required.	Baseline (week 0) to week 24
Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good	PGATE is an assessment tool used to rate the treatment effect of the medication on atopic dermatitis (AD), with scores ranging from 0 to 4 (0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent), i.e., higher score indicated higher treatment effect.	At week 24

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Trial Transparency Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): March 21, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: OBS17399 (Other Identifier: Sanofi Identifier); U1111-1269-6618 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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