Drug Survival of Target Therapies in Atopic Dermatitis

NCT06882148 | Recruiting

• 1 other identifier: 5909
• Study Type: observational
• Target: 1,167
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• drug survival evaluation

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

  1 year

Secondary Outcomes (2)

• drug survival related to safety

  through study completion, an average of 3 year

• relationship between drug survival and clinical data

  through study completion, an average of 3 year

Interventions

target therapies (biological drug, small molecules) DRUG

describe the drug sruvival rate of the different approved drugs

Also known as: selective drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients affected by moderate-severe atopic dermatitis undergoing target therapies for AD (upadacitinib, baricitinib, abrocitinib, dupilumab, tralokinumab)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

fondazione policlinico universitario agostino gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Biological Products

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Ketty Peris, Prof

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ketty peris, Prof

CONTACT

+390630155284; ketty.peris@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: March 18, 2025
• Study Start: October 12, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

IT (1)