A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis

Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea

The purpose of this non-interventional study is to learn about the safety and effectivness of Cibinqo Tablet for the possible treatment of atopic dermatitis (AD).

AD is a long-lasting itchy red rash, caused by a skin reaction.

This study is seeking participants who:

1. Are patients with moderate to severe AD who have been waiting to start treatment with Cibinqo
2. Have evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s) or legal guardian, have been informed of all important details of the study Investigators will collect and record the information on each participant's experiences with Cibinqo. This study medicine is a tablet which is taken by mouth. Participants will be observed for about a year. During this time, we will study the experiences of people receiving the study medicine to help us decide if the study medicine is safe and effective.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Abrocitinib

Detailed Description

This study is a single country, multicenter, prospective, non-interventional, observational post marketing surveillance study to evaluate the safety and effectiveness of Cibinqo® Tablet in participants with moderate to severe AD in routine clinical practice in Korea.

The purpose of this study is to evaluate the safety and effectiveness of Cibinqo® Tablet in routine clinical practice for approved indications in Korea.

The study population for this study is participants 12 years of age and older who have been diagnosed with moderate to severe AD and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.

About 3000 participants will be enrolled in several centers in this study. Pfizer Pharmaceuticals Korea will conclude a post-marketing surveillance agreement with an investigator site before performing the study.

Each investigator will sequentially enroll all subjects to whom Cibinqo is prescribed for the first time according to the "Dosage and Administration" of the approved labeling and who agree to participate in this study by signing the data privacy statement used in place of the informed consent form until the total requested cases per center are collected for this study.

There is no mandatory fixed visit schedule. The investigator will collect patient data and record the information on each patient's case report form (CRF).

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• South Korea
  • Seoul, South Korea, 04631
    • Recruiting
    • Pfizer Tower

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population for this study is patients 12 years of age and older who have been diagnosed with moderate to severe Atopic Dermatitis (AD) and are determined to be treated with Cibinqo® Tablet according to the approved indications in routine clinical practice in Korea.

Description

This study is seeking participants who should meet the usual prescribing criteria for Cibinqo® Tablets as per the Local Product Document (LPD) and should be entered into the study at the physician's discretion.

Inclusion Criteria:

1. Patients with moderate to severe AD who have been determined to start treatment with Cibinqo Tablet according to the approved indications of the medicinal product.

   • Atopic Dermatitis Cibinqo Tablet is indicated for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis who have required systemic therapies.

2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study

Exclusion Criteria:

1. Patients who have previously received Cibinqo Tablet
2. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products

3. Patients who have contraindications to Cibinqo Tablet as specified in the approved LPD • Contraindications to Cibinqo Tablet

   • Patients with platelet count <150 × 103/mm3, an absolute neutrophil count (ANC) <1 × 103/mm3, an absolute lymphocyte count (ALC) <0.5 × 103/mm3 or who have a haemoglobin value <8 g/dL
   • Hypersensitivity to the active substance or to any of the excipients
   • Active serious systemic infetions, including tuberculosis(TB)
   • Severe hepatic impairment
   • Pregnancy and breast-feeding
   • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse Events (AE's) according to frequency	Up to 52 weeks from the time of first treatment
Number of participants with Adverse Drug Reactions (ADR's) according to frequency	up to 52 weeks from the time of first treatment
Number of participants with unexpected AE's according to frequency	up to 52 weeks from the time of first treatment
Number of participants with unexpected ADR's according to frequency	up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Events (SAE's) according to frequency	up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency	up to 52 weeks from the time of first treatment
Number of participants with Adverse Events of Special Interest (AESI) according to frequency	up to 52 weeks from the time of first treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving the Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >=2 points	At 12 weeks, and 52 weeks after the first treatment
Proportion of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline	At week 12 and 52 weeks after the first treatment
Proportion of Participants Achieving >=4 Points improvement in the severity of Pruritus Numerical Rating Scale (NRS) from baseline	At week 12 and 52 weeks after the first treatment

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): November 22, 2027

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Atopic Dermatitis, Abrocitinib, Cibinqo
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; abrocitinib
• Other Study ID Numbers: B7451074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.