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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT01001468
Eligibility Criteria:
Inclusion Criteria:
* Male or female Patients, ≥18 to ≤75 years of age, who have a diagnosis of chronic plaque psoriasis for at least 6 months
* Non-anorexic subjects with a BMI ≥20
* Psoriasis Area and Severity Index (PASI) score of ≥12
* Plaque psoriasis covering ≥10% of body surface area (BSA)
* Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point Physician Global Assessment (PGA) scale
Exclusion Criteria:
* The subject presents with the predominant type of psoriasis as guttate, erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis
* The subject has not undergone wash-out periods of sufficient duration for the following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or injected, psoriasis treatments; Phototherapy
* The subject anticipates getting enough ultra-violet light during the study to cause psoriasis to improve
* The subject has a known allergy or sensitivity to the study treatment(s) or to any of the excipients contained in the study drug formulation
* History of cancer, the exception is skin cancer
* Has a clinically significant systemic infection within 30 days of Day 0, or a history or presence of recurrent or chronic infection
* Evidence of tuberculosis as indicated by a positive tuberculin skin test or a quantiferon test in subjects known to have a + PPD and a negative chest x-ray at screening
* History of clinically significant hypoglycemia
* Subjects with currently active peptic ulcer / gastroesophageal reflux disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01001468
Study Brief:
Protocol Section:
NCT01001468