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Completed

NCT Number: 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

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.

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Key information

Conditions

Dermatitis Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational site Kuwait, Kuwait City, Kuwait

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About this study

24 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT

    Time frame: At weeks 4, 12, and 24

    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.

  2. Percentages (%) of patients with ADCT score less than 7

    Time frame: At weeks 4 and 12

    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.

  3. Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)

    Time frame: At week 24

    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).

  4. Mean change in SCORAD

    Time frame: From baseline (week 0) to week 24

    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).

  5. Number of patients with at least one type-2 inflammation comorbidity

    Time frame: Baseline (week 0) to week 24

    Comorbidities related to type-2 inflammation as (allergic rhinitis, bronchial asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis).

  6. Adverse events (AEs) related to dupilumab use

    Time frame: Baseline (week 0) to week 24

    Number of patients experiencing adverse events (AEs) related to dupilumab use.

  7. Serious adverse events (SAEs) related to dupilumab use

    Time frame: Baseline (week 0) to week 24

    Number of patients experiencing serious adverse events (SAEs) related to dupilumab use.

  8. Adverse events of special interest (AESI) related to dupilumab use

    Time frame: Baseline (week 0) to week 24

    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.

  9. Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI

    Time frame: Baseline (week 0) to week 24

    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.

  10. Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good

    Time frame: At week 24

    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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: AD-impaCT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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