NCT05391061Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1100 (estimated)
- First submitted
- 19 May 2022
- Start date
- 7 Jan 2023
- Primary completion date
- 22 Nov 2027
- Lead sponsor
- Pfizer
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05391061
What you commit to
- Study type: Observational
- Planned participants: 1100
- From 7 Jan 2023 to the primary completion date, 22 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received Cibinqo Tablet
- Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products
Lab values
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Tower Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.