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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT03493269
Eligibility Criteria:
Inclusion Criteria:
Part 1 (healthy male subjects)
* Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
* Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / \[height (m)\]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)
* Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
* Body mass index above or equal to 18.5 and lower or equal to 35 kg/m\*2 and a body weight above 50 kg
* A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.
Exclusion Criteria:
* History of hypersensitivity to any of the components of the study drug
* Any clinically relevant abnormal findings in safety laboratory parameters and ECG
* History of tuberculosis (TB) or active or latent tuberculosis
* Receipt of live or attenuated vaccine 90 days prior to the first dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03493269
Study Brief:
Protocol Section:
NCT03493269