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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT04123795
Eligibility Criteria:
Inclusion Criteria:
* Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
1. Body Surface Area (BSA) affected by psoriasis ≥10 %
2. Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
3. Psoriasis Area and Severity Index (PASI) score is ≥12 or
4. PASI score is ≥10 and \<12 with at least one of the following:
* \>Clinically relevant facial or scalp involvement
* \>Clinically relevant genital involvement
* \>Clinically relevant palm and sole involvement
* \>Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with \>50 % to \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
* Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy
Exclusion Criteria:
* Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
* Study participant has generalized pustular or erythrodermic psoriasis (PSO)
* Study participant has guttate PSO without plaque PSO
* Study participant has had a primary failure to an anti-tumor necrosis factor agent
* Study participant has had prior exposure to \>2 biologic therapies
* Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Screening/Baseline" version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04123795
Study Brief:
Protocol Section:
NCT04123795