A Study to Learn About the Study Medicine (Called Cibinqo) in People With Atopic Dermatitis

Launched by PFIZER · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Cibinqo to find out how safe and effective it is for people with atopic dermatitis (AD), a condition that causes a long-lasting itchy and red rash. The study is looking for participants who are 12 years old and older, have moderate to severe AD, and are about to start treatment with Cibinqo. To join, participants will need to provide signed consent, which confirms they understand the study's details.

During the study, participants will take Cibinqo tablets by mouth for about a year. Researchers will keep track of how the medicine affects them and any side effects they might experience. It's important to note that individuals who have already taken Cibinqo, are part of other clinical trials, or have certain health conditions may not be eligible to participate. This trial aims to gather valuable information that could help improve treatment options for people with atopic dermatitis.

Gender

ALL

Eligibility 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