Status:
RECRUITING
A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
12+ years
Brief Summary
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,...
Detailed Description
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 participant...
Eligibility Criteria
Inclusion
- 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.
- 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
Key Trial Info
Start Date :
January 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 22 2027
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT05391061
Start Date
January 7 2023
End Date
November 22 2027
Last Update
December 9 2025
Active Locations (1)
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1
Pfizer Tower
Seoul, South Korea, 04631