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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01986933
Eligibility Criteria:
Inclusion Criteria:
* ≥18 and ≤65 years of age at the time of consent.
* Patients with Atopic Dermatitis
* Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
* Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
* static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit
Exclusion Criteria:
* Serological evidence of hepatitis B virus or hepatitis C virus infection
* Known human immunodeficiency virus infection
* Ongoing treatment with specific or non-specific hyposensitization therapy for AD
* Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
* History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
* Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01986933
Study Brief:
Protocol Section:
NCT01986933