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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT02394561
Eligibility Criteria:
Inclusion Criteria:
1. Subject must have been able to understand and communicate with the investigator and to comply with the requirements of the study and must have given a written, signed and dated informed consent before any study related activity was performed.
2. Men or women at least 18 years of age at time of screening.
3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months (including concomitant psoriatic arthritis as per the Classification Criteria for Psoriatic Arthritis criteria \[CASPAR\]).
4. Moderate to severe psoriasis as defined at enrollment by:
* PASI score ≥ 10 or
* PASI score \> 5 but \< 10 and DLQI ≥10
5. Patients that are candidates for systemic therapy, whether treatment naïve or after failed response to other systemic therapy (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFα (or is intolerant and/or has a contraindication to these).
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
3. Anti-TNFα therapy within timelines depending on drug half-life.
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that was not anti-TNFα therapy.
6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
7. Ongoing use of corticosteroid topical treatments or UV therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02394561
Study Brief:
Protocol Section:
NCT02394561