An observational study in Dermatitis, Atopic, sponsored by Pfizer. Recruiting at 1 site in South Korea. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Pfizer · Observational
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:
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).
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
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.
Exclusion Criteria:
Patients who have contraindications to Cibinqo Tablet as specified in the approved LPD • Contraindications to Cibinqo Tablet
Tablets
Also known as: Cibinqo
Number of participants with Adverse Events (AE's) according to frequency
Time frame: Up to 52 weeks from the time of first treatment
Number of participants with Adverse Drug Reactions (ADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected AE's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with unexpected ADR's according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Events (SAE's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Serious Adverse Drug Reactions (SADR's) according to frequency
Time frame: up to 52 weeks from the time of first treatment
Number of participants with Adverse Events of Special Interest (AESI) according to frequency
Time frame: up to 52 weeks from the time of first treatment
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
Time frame: 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
Time frame: 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
Time frame: At week 12 and 52 weeks after the first treatment
Plan to share: 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.
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