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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT01393158
Eligibility Criteria:
Inclusion Criteria:
* Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment.
* Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease.
* Baseline EASI score must be greater than or equal to 11. A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-30.
* Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
* Subjects must meet the washout requirements
Exclusion Criteria:
* History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
* At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years.
* Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable.
* Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
* Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening.
* History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency \[CVID\]).
* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
* History of Human Immunodeficiency Virus (HIV) infection.
* Antibodies to Hepatitis C at screening.
* History of squamous cell carcinoma of the skin and thin melanoma.
* Systemic corticosteroid-dependent asthma.
* Active infection of any type at the time of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01393158
Study Brief:
Protocol Section:
NCT01393158