NCT07887867

Brief Summary

The purpose of this observational study is to learn about the effects of the study medicine (called abrocitinib) for the treatment of severe atopic dermatitis in people that were moved from previous novel therapies, known as "advanced" therapies. Atopic dermatitis is a long-lasting skin condition that causes the skin to become inflamed, dry, and itchy. This study is seeking participants who:

  • are 18 years of age or older;
  • have severe atopic dermatitis;
  • have previously been treated with advanced therapies authorised for atopic dermatitis and are moving to abrocitinib (100 mg or 200 mg);
  • have received no more than two authorised advanced therapies for their atopic dermatitis. All participants will receive study medicine, abrocitinib as part of their usual medical care. The decision to give the study medicine is made by their dermatologist. This decision is independent of participation in the study. Abrocitinib will be taken by mouth at home once daily as prescribed by the treating doctor. We will examine the experiences of people receiving abrocitinib for up to one year after starting abrocitinib. We will look back at the information up to 6 months before they have started taking abrocitinib. This will help us learn how abrocitinib affects severe atopic dermatitis in people who have moved from other authorised advanced therapies. Participants will take part in this study for 1 year. During this time, they will have about 5 visits. These visits are a part of their routine care. During the visits, the doctor will assess how severe atopic dermatitis is. Participants may be asked questions about their symptoms and how the condition affects their daily life. No additional clinic visits, tests, or procedures are required for this study, beyond normal clinical practice.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
22mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Oct 2026Aug 2028

First Submitted

Initial submission to the registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

September 29, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

Dermatitis, Atopic; Abrocitinib; Janus Kinase Inhibitors; Pruritus; Quality of Life; Treatment Switching; Real-World Evidence

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Eczema Area and Severity Index (EASI) <7

    Week 24

Secondary Outcomes (19)

  • EASI 90

    Week 4, 12, 24, 52

  • Change from baseline in Eczema Area and Severity Index (EASI) Score

    Baseline, Week 4, 12, 24, 52

  • Change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS) Score

    Baseline, Week 4, 12, 24, 52

  • Percentage of Participants Achieving PP-NRS <=1

    Week 4, 12, 24, 52

  • Change from baseline in Investigator's Global Assessment (IGA) Score

    Week 4, 12, 24, 52

  • +14 more secondary outcomes

Study Arms (1)

Patients switched to abrocitinib

Adult patients with severe atopic dermatitis who switched from previous advanced therapies (dupilumab, lebrikizumab, tralokinumab, baricitinib, upadacitinib) to abrocitinib according to routine clinical practice

Drug: abrocitinib

Interventions

Abrocitinib administered according to routine clinical practice at doses of 100 mg or 200 mg once daily.

Patients switched to abrocitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

severe atopic dermatitis adult (\>=18 years) patients of both sexes who, according to clinical practice, have been switched directly to abrocitinib 100 mg or 200 mg after a maximum of 2 previous advanced therapies for the treatment of severe atopic dermatitis, including biologics (i.e., dupilumab, lebrikizumab, tralokinumab) and/or JAKis (i.e., baricitinib, upadacitinib).

You may qualify if:

  • \>=18 years of age on date of the enrolment visit
  • Severe atopic dermatitis diagnosed in accordance with guidelines used per clinical practice
  • Patients have agreed to switch from a prior advanced therapy for severe AD (i.e., dupilumab, lebrikizumab, tralokinumab, baricitinib, or upadacitinib) to abrocitinib 100 mg or 200 mg, based on the Investigator's clinical judgment and independent of study participation.
  • Evidence of a personally signed and dated informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Dermatitis, AtopicDermatitisPruritus

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 21, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.