Dermatitis, AtopicNCT07887867
A Study to Learn About the Study Medicine Abrocitinib in People With Severe Atopic Dermatitis Who Have Switched From Other Therapies
An observational study of Dermatitis, Atopic, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- abrocitinib
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- >=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
- Exclusion Criterion: Patients treated with more than 2 advanced therapies for AD, either biologics or JAKis
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A REAL-WORLD RETRO-PROSPECTIVE SINGLE COHORT STUDY EVALUATING THE EFFECTIVENESS OF ABROCITINIB (100/200 MG) IN PATIENTS AFFECTED BY SEVERE ATOPIC DERMATITIS SWITCHED PER CLINICAL PRACTICE FROM OTHER ADVANCED THERAPIES, INCLUDING BIOLOGICS AND/OR OTHER JAK INHIBITORS - ABRO-SWITCH
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.
Read more
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.
- Conditions
- Dermatitis, Atopic
- Being tested
- abrocitinib
- Keywords
- Dermatitis, Atopic; Abrocitinib; Janus Kinase Inhibitors; Pruritus; Quality of Life; Treatment Switching; Real-World Evidence
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abrocitinibDrug
Abrocitinib administered according to routine clinical practice at doses of 100 mg or 200 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: abrocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) <7
Measured: Week 24
Secondary outcomes (19)
EASI 90
Proportion of participants reaching 90% improvement in EASI from baseline
Measured: Week 4, 12, 24, 52
Change from baseline in Eczema Area and Severity Index (EASI) Score
Measured: Baseline, Week 4, 12, 24, 52
Change from baseline in Peak Pruritus-Numeric Rating Scale (PP-NRS) Score
Measured: Baseline, Week 4, 12, 24, 52
Percentage of Participants Achieving PP-NRS <=1
Measured: Week 4, 12, 24, 52
Change from baseline in Investigator's Global Assessment (IGA) Score
Measured: Week 4, 12, 24, 52
Percentage of Participants Achieving IGA 0-1
Measured: Week 4, 12, 24, 52
Change from baseline in Dermatology Life Quality Index (DLQI) Score
Measured: Week 4, 12, 24, 52
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Score
Measured: Week 4, 12, 24, 52
Change from baseline in Sleep Disturbance Numeric Rating Scale (SD-NRS) Score
Measured: Week 4, 12, 24, 52
Percentage of Participants Achieving Minimal Disease Activity (MDA)
Measured: Week 4, 12, 24, 52
Demographics Characteristics: Percentage of Participants by Age, Gender, Education, Occupation, Family Status
Measured: Baseline
Number of Participants by Age-at-Onset Category for Atopic Dermatitis
Age at onset
Measured: Baseline
Number of Participants by Atopic Dermatitis Phenotype
Measured: Baselines, Week 4, 12, 24, 52
Number of Participants with Each Difficult-to-Treat Body Area
Measured: Baseline, Week 4, 12, 24, 52
Clinical Characteristics: Duration of Previous Advanced Therapy Before Switching to Abrocitinib
Measured: Baseline
Number of participants with Each Atopic Comorbidity
Measured: Baseline, Week 4,12,24,52
Number of Participants with Each Non-Atopic Comorbidity
Measured: Baseline, Week 4,12,24,52
Adherence to Abrocitinib
Percentage of actual vs. expected therapeutic dosages as reported by the participants.
Measured: Week 4,12, 24, 52
Persistence to Abrocitinib
Percentage of participants on treatment at week 52.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887867
- Sponsor's protocol ID
- B7451138
- Other IDs
- ABRO-SWITCH
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.