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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT01265667
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 to 80 years of age, inclusive
* Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
* Duration of psoriasis of at least 6 months
* Physician global assessment (PGA) ≥3
* Candidate for systemic treatment or phototherapy for psoriasis
* Electrocardiogram (ECG) is normal
* Females of child-bearing potential must have a negative serum pregnancy test
* Females of child-bearing potential must be willing to use 2 methods of contraception
* Ability to complete the study in compliance with the protocol
* Ability to understand and provide written informed consent.
Exclusion Criteria:
* Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
* Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
* Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
* Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
* Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
* Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
* Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
* Liver aminotransferase levels greater than the laboratory's upper limit of normal
* Significant acute or chronic medical or psychiatric illness
* Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01265667
Study Brief:
Protocol Section:
NCT01265667