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NCT05250115Terminated

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

Run by Pfizer

This is a Prospective, Single-arm, Multicenter, Observational Non-interventional Study (NIS) in Germany of Patient Characteristics, Usage, and Effectiveness of Abrocitinib in Patients With Moderate to Severe Atopic Dermatitis (AD)

Source: ClinicalTrials.gov · Last updated 29 Sept 2025

Reason given: Business decision: Due to the slow recruitment, the sponsor decided to discontinue the study early.

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Observational
Enrollment
112 (actual)
First submitted
10 Feb 2022
Start date
10 May 2022
Primary completion date
25 Jul 2024
Lead sponsor
Pfizer
NCT number
NCT05250115

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Contraindications according to SmPC
  • 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

Who the study is looking for

  • 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
    • abrocitinib naive or,
    • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (38)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hautärztliche GemeinschaftspraxisAhausGermanyUnknown status
Hautarztpraxis Dr. Virgil MihaescuAugsburgGermanyUnknown status
Dermatologie Bad Kreuznach - Dr. med. Georg MauerBad KreuznachGermanyUnknown status
Praxis Dr. A. MagerlBensheimGermanyUnknown status
HautzentrumBergenGermanyUnknown status
Hautzentrum WeißenseeBerlinGermanyUnknown status
Dr. Christiane Handrick HautarztpraxisBerlinGermanyUnknown status
Hautarztpraxis Dr. med. Thomas SchirmerBerlinGermanyUnknown status
Dres. Ziethen-Stavermann GbRBerlinGermanyUnknown status
Hautarztpraxis WeidBingenGermanyUnknown status
Hautarztpraxis an der Hase StudienzentrumBramscheGermanyUnknown status
Hautärzte BraunschweigBraunschweigGermanyUnknown status
Elbe Kliniken Stade - Buxtehude GmbHBuxtehudeGermanyUnknown status
Hautarztpraxis Dr. med. Daniela KascheBuxtehudeGermanyUnknown status
Praxis Dr. VothCologneGermanyUnknown status
BAG Freitag und KnöllFalkenseeGermanyUnknown status
Haut- und Laserzentrum Freisung Prof. KurzenFreisingGermanyUnknown status
ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert JablonkaGelsenkirchenGermanyUnknown status
Hautarztpraxis Dr. med Michael LothGernsbachGermanyUnknown status
Hautarztpraxis Dr. Brinkmann, Schult & Samimi-FardGladbeckGermanyUnknown status
Hautarztpraxis Dr. med. Matthias LüttenHamburgGermanyUnknown status
Universitätsklinikum Hamburg-EppendorfHamburgGermanyUnknown status
Cutaneum Praxis Dr. BuckHamburgGermanyUnknown status
dermaSANAKarlsruheGermanyUnknown status
KosmedikulmKulmbachGermanyUnknown status
Dr. Beate SchwarzLangenauGermanyUnknown status
"Magdeburger company for Medical studies & Services"MagdeburgGermanyUnknown status
Dermatologische Gemeinschaftspraxis Dres. Quist PartGMainzGermanyUnknown status
Dermatologie Mölln, Praxis Dr SegertMöllnGermanyUnknown status
ZENTderma, Dr. Rolf OstendorfMönchengladbachGermanyUnknown status
Hautarztpraxis Dorittke / KardorffMönchengladbachGermanyUnknown status
Praxis Dr. QuackMünchenGermanyUnknown status
Hautarztpraxis Dr. Susanne Gißler-WalterMutterstadtGermanyUnknown status
Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther VölkelNurembergGermanyUnknown status
Hautarztpraxis MortazawiRemscheidGermanyUnknown status
Dermatologische Spezialpraxis Dr. med. Ralph von KiedrowskiSeltersGermanyUnknown status
Dermatologisches Studienzentrum Hunsrück - DSHSimmernGermanyUnknown status
Hautarztpraxis Dr. HoffmannWittenGermanyUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.