Observes safety of abrocitinib tablets in Korean patients with atopic dermatitis
Studies the Cibinqo tablet, taken by mouth, in people with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Pfizer TowerSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05391061
- Record updated
- 9 December 2025
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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; 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: Patients who have previously received Cibinqo Tablet; Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products; 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.
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.