A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

NCT ID: NCT05250115

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2024-07-25

Brief Summary

The purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called Abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (AD). AD is a long-lasting disease that causes redness and irritation of the skin. This non-interventional study is seeking participants who is eligible for Abrocitinib treatment according to the summary of product characteristics (SmPC):

• Are aged at least 18 years old
• Have a confirmed diagnosis of AD by a skin doctor
• Decide to start treatment with Abrocitinib as part of routine clinical practice
• Have a personally signed and dated informed consent document. This is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects

Participants will take the medicinal product as prescribed in the real-world setting. We will examine the experiences of people receiving Abrocitinib. This will help us determine if the medicinal product is effective and safe. Participants will take part in this study for 3 months. During this time, participants will be followed up from the date of their first Abrocitinib prescription for 12 months. During this non-interventional study, some participants may switch to other therapies after their initial Abrocitinib therapy. We will follow these participants further when they switch therapy to monitor their experiences. Participant documentation is expected quarterly as per standard clinical practice.

Conditions

Dermatitis, Atopic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Evaluate the effectiveness, usage and patient characteristics of real-world use of Abrocitinib

This is a 60-month, prospective, non-interventional, multicenter study to evaluate the effectiveness, usage and patient characteristics of abrocitinib in patients with moderate to severe AD in a real-world setting.

Eligible patients will be followed up from the date of first Abrocitinib prescription for 12 months. from the date of enrollment. Patients who are switched from the initial abrocitinib therapy to other therapies continue to be observed. Patient documentation is expected quarterly as per standard clinical practice.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years
• Confirmed diagnosis of AD by dermatologist prior to study inclusion
• Patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being

1. abrocitinib naive or,

2. patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion

• Patient is eligible for abrocitinib treatment according to Summary of Product Characteristics (SmPC)
• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study

Exclusion Criteria

• Contraindications according to SmPC
• Receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period
• Patients being treated with abrocitinib within a time period of <28 days prior to the timepoint of study inclusion
• Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the non-interventional study
• Patients who are unable to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Elbe Kliniken Stade - Buxtehude GmbH

Buxtehude, Lower Saxony, Germany

ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka

Gelsenkirchen, North Rhine-Westphalia, Germany

Dermatologische Gemeinschaftspraxis Dres. Quist PartG

Mainz, Rhineland-Palatinate, Germany

"Magdeburger company for Medical studies & Services"

Magdeburg, Saxony-Anhalt, Germany

Hautärztliche Gemeinschaftspraxis

Ahaus, , Germany

Hautarztpraxis Dr. Virgil Mihaescu

Augsburg, , Germany

Dermatologie Bad Kreuznach - Dr. med. Georg Mauer

Bad Kreuznach, , Germany

Praxis Dr. A. Magerl

Bensheim, , Germany

Hautzentrum

Bergen, , Germany

Dr. Christiane Handrick Hautarztpraxis

Berlin, , Germany

Dres. Ziethen-Stavermann GbR

Berlin, , Germany

Hautarztpraxis Dr. med. Thomas Schirmer

Berlin, , Germany

Hautzentrum Weißensee

Berlin, , Germany

Hautarztpraxis Weid

Bingen, , Germany

Hautarztpraxis an der Hase Studienzentrum

Bramsche, , Germany

Hautärzte Braunschweig

Braunschweig, , Germany

Hautarztpraxis Dr. med. Daniela Kasche

Buxtehude, , Germany

Praxis Dr. Voth

Cologne, , Germany

BAG Freitag und Knöll

Falkensee, , Germany

Haut- und Laserzentrum Freisung Prof. Kurzen

Freising, , Germany

Hautarztpraxis Dr. med Michael Loth

Gernsbach, , Germany

Hautarztpraxis Dr. Brinkmann, Schult & Samimi-Fard

Gladbeck, , Germany

Cutaneum Praxis Dr. Buck

Hamburg, , Germany

Hautarztpraxis Dr. med. Matthias Lütten

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

dermaSANA

Karlsruhe, , Germany

Kosmedikulm

Kulmbach, , Germany

Dr. Beate Schwarz

Langenau, , Germany

Dermatologie Mölln, Praxis Dr Segert

Mölln, , Germany

ZENTderma, Dr. Rolf Ostendorf

Mönchengladbach, , Germany

Hautarztpraxis Dorittke / Kardorff

Mönchengladbach, , Germany

Hautarztpraxis Dr. Susanne Gißler-Walter

Mutterstadt, , Germany

Praxis Dr. Quack

München, , Germany

Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel

Nuremberg, , Germany

Hautarztpraxis Mortazawi

Remscheid, , Germany

Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski

Selters, , Germany

Dermatologisches Studienzentrum Hunsrück - DSH

Simmern, , Germany

Hautarztpraxis Dr. Hoffmann

Witten, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7451089

To obtain contact information for a study center near you, click here.

Other Identifiers

ABROAD

Identifier Type: OTHER

Identifier Source: secondary_id

B7451089

Identifier Type: -

Identifier Source: org_study_id