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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT03310320
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed informed consent prior to any study specific procedures.
* At least 6 months documented history with a diagnosis of moderate to severe plaque psoriasis as defined by the Psoriasis Area and Severity Index (PASI), psoriasis Body Surface Area (BSA) and static Physician Global Assessment (sPGA).
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
* History and/or presence of tuberculosis, hepatitis, HIV. Other opportunistic infections within 6 months of the study.
* Clinically significant laboratory abnormalities.
* Clinically important abnormalities in rhythm, conduction or morphology of the digital Electrocardiogram (ECG) as considered by the Investigator may interfere with the interpretation of study data.
* Current treatment or treatment for psoriasis with biological therapies within 6 months of study.
* Efficacy and safety failure of biologic therapies targeting the IL-17 and IL12/23 pathway at any time.
* Current treatment or history of treatment for psoriasis with non-biological systemic medications within 4 weeks of Day 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03310320
Study Brief:
Protocol Section:
NCT03310320