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

NCT05250115 | Terminated Results

• 2 other identifiers: B7451089ABROAD
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 38

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

Keywords

Atopic Dermatitis; Abrocitinib; JAK inhibitors

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) at Month 3

  The IGA is a tool used to assess the severity of AD (excluding scalp, palms and soles) on a 5-point scale that ranges from 0 to 4, where 0 indicates clear (no signs of AD), 1 indicates almost clear (minimal signs of AD), 2 indicates mild AD, 3 indicates moderate AD and 4 indicates severe AD, higher scores indicated greater severity of AD. Percentage of participants with score of "Clear" (score 0) or "Almost Clear" (score 1) according to IGA were reported in this outcome measure.

  At Month 3

• Percentage of Participants With 75% Reduction From Baseline in Eczema Area and Severity Index (EASI) at Month 3

  The EASI assessed both clinical signs of AD as well as extent of disease. For body regions such as "head and neck", "trunk", "upper extremities" and "lower extremities" the extent of eczema was assessed by an area score between 0 (0% of body surface area \[BSA\] affected) and 6 (90 to 100% of BSA affected), respectively. For each area the severity of clinical signs of AD such as "erythema", "edema/papulation", "excoriation" and "lichenification" were scored from 0 to 3, respectively where 0= absent; 1= mild; 2= moderate; 3= severe. The scores for the signs were added for each area and multiplied by the respective area score. The EASI for an individual was calculated as weighted sum: 0.1\*score for head/neck + 0.3\*score for trunk + 0.2\*score for upper extremities + 0.4\*score for lower extremities. The total score ranged from 0 to 72, higher scores represented greater severity of AD. EASI 75 response was defined as at least a 75% reduction in EASI relative to baseline.

  At Month 3

Secondary Outcomes (21)

• Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) Until End of Study

  From Baseline (Day 1) up to end of study (Month 12)

• Percentage of Participants With 75% Reduction From Baseline in EASI Score Until End of Study

  From Baseline (Day 1) up to end of study (Month 12)

• Percentage of Participants With 90% Reduction From Baseline in EASI Score Until End of Study

  From Baseline (Day 1) up to end of study (Month 12)

• Percentage of Participants Who Achieved IGA Score of Clear (0) or Almost Clear (1) and a Reduction of >= 2 Points From Baseline Until End of Study

  From Baseline (Day 1) up to end of study (Month 12)

• Percentage Change From Baseline in IGA Total Score at Months 1, 3, 6, 9 and 12

  Baseline (Day 1), Months 1, 3, 6, 9 and 12

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective, single-arm, multi-center, observational non-interventional study looking at adult patients with moderate-severe atopic dermatitis, who have been chosen to start treatment with Abrocitinib in Germany according to the current routine practice of the treating physician.

You may qualify if:

• Patients aged ≥18 years
• 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,
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Elbe Kliniken Stade - Buxtehude GmbH

Buxtehude, Lower Saxony, 21614, Germany

Location

ÜUeberoertliche Gemeinschaftspraxis Jost Kai Rietkoetter Robert Jablonka

Gelsenkirchen, North Rhine-Westphalia, 32423, Germany

Location

Dermatologische Gemeinschaftspraxis Dres. Quist PartG

Mainz, Rhineland-Palatinate, 55128, Germany

Location

"Magdeburger company for Medical studies & Services"

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Hautärztliche Gemeinschaftspraxis

Ahaus, 48688, Germany

Location

Hautarztpraxis Dr. Virgil Mihaescu

Augsburg, 86150, Germany

Location

Dermatologie Bad Kreuznach - Dr. med. Georg Mauer

Bad Kreuznach, 55543, Germany

Location

Praxis Dr. A. Magerl

Bensheim, 64625, Germany

Location

Hautzentrum

Bergen, 18528, Germany

Location

Dr. Christiane Handrick Hautarztpraxis

Berlin, 10117, Germany

Location

Dres. Ziethen-Stavermann GbR

Berlin, 12353, Germany

Location

Hautarztpraxis Dr. med. Thomas Schirmer

Berlin, 12489, Germany

Location

Hautzentrum Weißensee

Berlin, 13086, Germany

Location

Hautarztpraxis Weid

Bingen, 55411, Germany

Location

Hautarztpraxis an der Hase Studienzentrum

Bramsche, 49565, Germany

Location

Hautärzte Braunschweig

Braunschweig, 38114, Germany

Location

Hautarztpraxis Dr. med. Daniela Kasche

Buxtehude, 21614, Germany

Location

Praxis Dr. Voth

Cologne, 50677, Germany

Location

BAG Freitag und Knöll

Falkensee, 14612, Germany

Location

Haut- und Laserzentrum Freisung Prof. Kurzen

Freising, 85354, Germany

Location

Hautarztpraxis Dr. med Michael Loth

Gernsbach, 76593, Germany

Location

Hautarztpraxis Dr. Brinkmann, Schult & Samimi-Fard

Gladbeck, 45964, Germany

Location

Cutaneum Praxis Dr. Buck

Hamburg, 20095, Germany

Location

Hautarztpraxis Dr. med. Matthias Lütten

Hamburg, 20095, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

dermaSANA

Karlsruhe, 76131, Germany

Location

Kosmedikulm

Kulmbach, 95326, Germany

Location

Dr. Beate Schwarz

Langenau, 89129, Germany

Location

Dermatologie Mölln, Praxis Dr Segert

Mölln, 23879, Germany

Location

ZENTderma, Dr. Rolf Ostendorf

Mönchengladbach, 41061, Germany

Location

Hautarztpraxis Dorittke / Kardorff

Mönchengladbach, 41236, Germany

Location

Hautarztpraxis Dr. Susanne Gißler-Walter

Mutterstadt, 67112, Germany

Location

Praxis Dr. Quack

München, 81539, Germany

Location

Dermatologische Praxis im Hautzentrum Johannis Dr. med. Esther Völkel

Nuremberg, 90419, Germany

Location

Hautarztpraxis Mortazawi

Remscheid, 42897, Germany

Location

Dermatologische Spezialpraxis Dr. med. Ralph von Kiedrowski

Selters, 56242, Germany

Location

Dermatologisches Studienzentrum Hunsrück - DSH

Simmern, 55469, Germany

Location

Hautarztpraxis Dr. Hoffmann

Witten, 58453, Germany

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: May 10, 2022
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (38)