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NCT Number: NCT06882148

Drug Survival of Target Therapies in Atopic Dermatitis

This is an observational study with drug to evaluate the drug survival of approved target therapies in atopic dermatitis. Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included.

During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected.

Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

fondazione policlinico universitario agostino gemelli IRCCS

Rome, 00168, Italy

Location status: Recruiting

Location contact

ketty peris fondazione policlinico universitario agostino gemelli IRCCS, professor

CONTACT

[email protected]

063015 85284

About this study

Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a prevalence of 10% in adults and 20% in children. It is of primary importance to select the best treatment option as as relapses occur quickly after discontinuation.

Drug survival rate reflects efficacy, tolerability, and safety of a drug, influencing disease management and healthcare costs. AD treatment has been revolutionized by new treatments that include monoclonal antibodies (dupilumab, tralokinumab) and JAK inhibitors (abrocitinib, baricitinib, upadacitinib).

This observational study evaluates the 12-month drug survival of these approved treatments in moderate-to-severe atopic dermatitis, assessing their safety. The study also aims to evaluate the relationship between drug survival and clinical, laboratory, and pharmacological factors.

Patients affected by moderate-severe atopic dermatitis who will start therapy with approved target drugs (dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib) for AD will be enrolled. Patients already on therapy with these drugs will also be included.

During the baseline and follow up visits, clinical and demographic data will be collected, according to ordinary clinical practice. Current or retrospective disease severity scores will also be collected.

Among the main: Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), Pruritus Numerical Rating Scale (NRS pruritus), Sleep Numerical Rating Scale (NRS sleep), Patient Oriented Eczema Measure (POEM).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Diagnosed with moderate-to-severe atopic dermatitis (EASI>24)
  • Undergoing therapy (retrospective cohort) or undertaking systemic therapy with a biological drug or small molecules
  • (for retrospective data) presence of at least one follow-up visit after the start of treatment for which clinical and demographic data were collected at baseline and follow-up visits.
  • Signature of informed consent to the study and to the processing of personal data for the research

Exclusion criteria

  • Patients under 18 years of age
  • Patients who have undergone systemic therapy with a biological drug or small molecules for whom the start date of treatment is not available and/or no clinical-demographic data were collected at baseline and at follow-up visits.
  • Absence of informed consent to the study and processing of personal data for research purposes.

Treatment and study plan

target therapies (biological drug, small molecules)

Drug

describe the drug sruvival rate of the different approved drugs

Other names: selective drugs

Primary outcomes

  1. drug survival evaluation

    Time frame: 1 year

    evaluate the 12-month drug survival rate, for each of the 5 biological drugs/small molecules under study.

Secondary outcomes

  1. drug survival related to safety

    Time frame: through study completion, an average of 3 year

    Number of participants with treatment-related adverse events

  2. relationship between drug survival and clinical data

    Time frame: through study completion, an average of 3 year

    Evaluate the relationship between drug survival and clinical, laboratory and pharmacological determinants.

Study contacts

Contact information is provided by the study sponsor or research team.

ketty peris, Prof

CONTACT

[email protected]

+390630155284

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluation of Drug Survival of Target Therapies in Atopic Dermatitis

Acronym: VADRUDA

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

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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