Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.

Launched by PFIZER · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called abrocitinib for patients with moderate to severe atopic dermatitis, a skin condition that causes itchy and inflamed skin. The trial aims to understand how effective this treatment is for people who have not had good results from, or could not tolerate, up to two previous biologic therapies, which are special medications approved for this condition. The research will take place in multiple locations across the United States and will include both adults and adolescents aged 12 and older.

To be part of the study, participants must have had chronic atopic dermatitis for at least a year and have a diagnosis confirmed by a dermatologist. They should also be willing to take abrocitinib as part of their treatment. The trial will observe the experiences of about 150 patients over approximately 12 months, and participants can expect to attend regular clinic visits and complete some questionnaires about their health. It’s important to note that individuals with other active skin diseases or those who have already used abrocitinib are not eligible for this study.

Gender

ALL

Eligibility criteria

• • This NI study will enroll 150 patients from approximately 15 sites across the US. The study population eligible for enrollment includes adult and adolescent patients aged ≥12 years diagnosed with moderate to severe AD who receive at least one dose of abrocitinib and satisfy the inclusion and exclusion criteria. Patients who had inadequate response or intolerance to previous ≤2 biologic therapies will be included in this study as there is a lack of effectiveness data for abrocitinib in these patients. As this will be an observational study, there will be no sampling and all patients that meet the inclusion and exclusion criteria will be recruited consequently. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Regarding the inclusion and exclusion criteria, in the real-world setting recruitment may be slower than expected, thus depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study.
• • 9.2.1. Inclusion Criteria
• Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
• • 1. Participants who have chronic AD that has been present for ≥1 year before screening.
• • 2. Male and female patients aged \>12 years at baseline.
• • 3. Patients with diagnosis of moderate-to-severe atopic dermatitis confirmed by a certified dermatologist, who are prescribed abrocitinib for use in accordance with the product label (USPI) and independently of the decision to enroll the patient in this study
• • 4. Patients who have inadequate responses or are intolerant to ≤2 previous biologic therapy approved for M2S AD. (Patients shall have had an inadequate response and/or intolerance to at least one, but no more than 2 biologic therapies approved for moderate-to-severe AD)
• • 5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the study, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
• • 6. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.
• • 9.2.2. Exclusion Criteria
• Patients meeting any of the following criteria will not be included in the study:
• • 1. Patients, that currently have active forms of other inflammatory skin diseases, other than AD or have evidence of skin conditions (eg, psoriasis, seborrheic dermatitis, Lupus) at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment.
• • 2. Patients previously treated with abrocitinib or other oral/systemic JAK inhibitors
• • 3. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
• • 4. Patient eligibility should be reviewed, documented, and confirmed by an appropriately qualified member of the investigator's study team before patients are enrolled in the study.