Abrocitinib for moderate-to-severe atopic dermatitis after inadequate response to biologics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center observational study enrolling about 150 patients across approximately 15 U.S. sites who receive at least one dose of abrocitinib. Eligible participants are adolescents and adults (≥12 years) with moderate-to-severe atopic dermatitis and prior inadequate response or intolerance to ≤2 approved biologic therapies. The study will collect clinical measures and patient-reported outcomes over real-world treatment courses without assigning interventions. Enrollment is expected to be open for roughly 12 months after the first patient is enrolled.

Why it matters

Who can join: the full rules

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.

Where it's running

• Allergy and Asthma Medical Group and Research Center
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Abrocitinib for eczema and patchy hair loss in people with Down syndrome

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• Safety of Abrocitinib in Pregnant Women and Their Babies

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• Learning about Abrocitinib for treating moderate to severe atopic dermatitis in adults

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• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

  A cream called roflumilast 0.3% is tested once daily to see if it helps people with moderate to severe atopic dermatitis, compared to a non-medicated cream, across ages 6 and up.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.