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:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT07276620
Eligibility Criteria:
Inclusion Criteria:
* Aged between 12 and 75 years;
* Diagnosed with moderate-to-severe atopic dermatitis (AD) ;
* Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
Exclusion Criteria:
* Subject has any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
1. Absolute lymphocyte count of \<0.50 x 10\^9 /L (\<500/mm3);
2. Absolute Neutrophil Count (ANC) of \<1 X 10\^9/L (\<1000/mm3);
3. Hemoglobin level \< 80 g/L.
* Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
* Subject with a prior history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism, cerebrovascular accidents and those with known inherited conditions that predispose to hypercoagulability.
* Presence of an active severe acute or chronic bacterial, fungal, or viral infection requiring systemic therapy.
* Subjects with active tuberculosis or known active hepatitis B and/or hepatitis C infection.
* Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
* Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
75 Years
Study:
NCT07276620
Study Brief:
Protocol Section:
NCT07276620