Actively Recruiting
Post Marketing Surveillance Study for Cibinqo Tablet (Abrocitinib) in Patients with Moderate to Severe Atopic Dermatitis in Korea
Led by Pfizer · Updated on 2025-12-09
1100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Cibinqo Tablet (Abrocitinib) for treating moderate to severe atopic dermatitis (AD), a long-lasting itchy red rash caused by a skin reaction. This is a non-interventional, observational post-marketing surveillance study conducted in Korea with about 3000 participants aged 12 years and older who have been diagnosed with moderate to severe AD and are prescribed Cibinqo according to approved guidelines. Participants will take Cibinqo tablets as prescribed in routine clinical practice, with no mandatory fixed visit schedule. Investigators will collect and record data from each patient during their treatment period, following approved dosage and administration. The study aims to observe participants for up to one year from the first treatment to assess safety and effectiveness in real-world settings. Participants will have their experiences recorded in case report forms without additional mandatory procedures. Researchers will monitor adverse events, serious adverse events, and specific safety concerns up to 52 weeks after starting treatment. Effectiveness will be measured by improvements in skin condition and itch severity over 12 and 52 weeks. The total participation time depends on the patient's treatment course and monitoring needs.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate to severe atopic dermatitis who are starting treatment with Cibinqo Tablet according to approved indications
- Patients 12 years of age or older
- Evidence of a personally signed and dated informed consent document from the patient or their parent(s)/legal guardian
You will not qualify if you...
- Patients who have previously received Cibinqo Tablet
- Patients currently participating in other studies with therapeutic interventions or investigational products
- Patients with contraindications to Cibinqo Tablet such as low platelet count, low neutrophil or lymphocyte counts, or low hemoglobin
- Patients with hypersensitivity to Cibinqo or its ingredients
- Patients with active serious systemic infections including tuberculosis
- Patients with severe liver impairment
- Pregnant or breastfeeding patients
- Patients with rare hereditary problems like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 52 weeks from the time of first treatment
Participants who are prescribed Cibinqo Tablet in routine clinical practice are observed for safety and effectiveness outcomes.
Visits as per routine clinical practice with no mandatory fixed schedule
Trial Site Locations
Total: 1 location
1
Pfizer Tower
Seoul, South Korea, 04631
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here