Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT05391061
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05391061
Study Brief:
Protocol Section:
NCT05391061