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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00673556
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
* Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
* CD4+ T lymphocyte counts at or above the lower limit of normal
Exclusion Criteria:
* Clinically significant abnormal hematology values or blood chemistry values
* AST or ALT ≥ 3x the upper limit of normal
* Other types of Psoriasis
* Serious infection within the 3 months prior to the first dose of study drug
* History of drug or alcohol abuse within the past 2 years
* Antibody positive for HIV
* History of malignancy
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
* Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
* Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
* Current treatment with any therapy for tuberculosis
* Previous exposure to Alefacept
* Nursing mothers, pregnant women, and women planning to become pregnant during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00673556
Study Brief:
Protocol Section:
NCT00673556