Abrocitinib for moderate-to-severe atopic dermatitis after inadequate response to biologics
A Prospective, Multi-center Observational Study Characterizing Clinical Outcomes of Patients Receiving Abrocitinib for Moderate-to-severe Atopic Dermatitis Who Had an Inadequate Response (or Intolerance) to ≤2 Previous Biologic Therapies Approved for Moderate-to-severe Atopic Dermatitis
This study will try abrocitinib in adolescents and adults (≥12 years) with moderate-to-severe atopic dermatitis who didn't respond to or couldn't tolerate up to two biologic treatments to see how it works in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | abrocitinib |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06899204 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adolescents and adults aged 12 years or older with moderate-to-severe atopic dermatitis who have had an inadequate response or intolerance to up to two approved biologic therapies and who start abrocitinib are the intended participants.
Not a fit: Patients with mild atopic dermatitis, children under 12, or individuals who cannot take abrocitinib due to contraindications are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could show that abrocitinib provides meaningful symptom improvement for patients with moderate-to-severe atopic dermatitis who failed prior biologic therapies, informing real-world treatment choices.
How similar studies have performed: Randomized controlled trials have shown abrocitinib is effective for moderate-to-severe atopic dermatitis, but real-world evidence specifically in patients who failed prior biologics is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Pfizer — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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.