Observing the effects of Cibinqo in patients with atopic dermatitis
Post Marketing Surveillance (PMS) Study for Cibinqo Tablet (Abrocitinib) in Patients With Moderate to Severe Atopic Dermatitis (AD) in Korea
This study is testing how well Cibinqo works and how safe it is for people aged 12 and older with moderate to severe atopic dermatitis in Korea over about a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05391061 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Cibinqo (Abrocitinib) in patients aged 12 and older with moderate to severe atopic dermatitis (AD) in Korea. Participants will be enrolled as they begin treatment with Cibinqo, and their experiences will be monitored over approximately one year. The study will collect data on the participants' responses to the medication in a real-world clinical setting, without a fixed visit schedule. The goal is to gather insights that will inform the ongoing use of Cibinqo for treating AD.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 and older diagnosed with moderate to severe atopic dermatitis who are starting treatment with Cibinqo.
Not a fit: Patients who have previously received Cibinqo or are participating in other therapeutic studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and effectiveness of Cibinqo for patients suffering from atopic dermatitis.
How similar studies have performed: Other studies have shown positive outcomes with similar observational approaches, but this specific study focuses on a newly approved medication.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Pfizer Tower — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.