Evaluating the effectiveness of target therapies for atopic dermatitis
Evaluation of Drug Survival of Target Therapies in Atopic Dermatitis
This study is testing how well certain new treatments for moderate-to-severe atopic dermatitis work over a year for adults who are starting or already using them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1167 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | dupilumab, tralokinumab, upadacitinib, abrocitinib, baricitinib |
| Locations | 1 site (Rome) |
| Trial ID | NCT06882148 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the drug survival rates of approved target therapies for moderate-to-severe atopic dermatitis, including monoclonal antibodies and JAK inhibitors. Patients aged 18 and older who are starting or currently on these therapies will be enrolled, and their clinical and demographic data will be collected during baseline and follow-up visits. The study aims to evaluate the relationship between drug survival and various clinical, laboratory, and pharmacological factors over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate-to-severe atopic dermatitis who are starting or currently undergoing therapy with specific approved target drugs.
Not a fit: Patients under 18 years of age or those without available treatment start dates and clinical data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment options for patients with moderate-to-severe atopic dermatitis.
How similar studies have performed: Other studies have shown success in evaluating drug survival rates for similar therapies, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rome
- fondazione policlinico universitario agostino gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Ketty Peris, Prof — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: ketty peris, Prof
- Email: ketty.peris@unicatt.it
- Phone: +390630155284
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.