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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01094093
Eligibility Criteria:
Inclusion Criteria:
Part A - Healthy Volunteers:
* Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination, clinical laboratory values, and ECG
* Additional inclusion criteria apply
Part B - Psoriasis Subjects:
* Male or female of non-reproductive potential subjects with PsO between 18 to 55 years-of-age
* Body mass index (BMI) between 18 and 32 kg/m2
* Normal or clinically acceptable physical examination (PE), clinical laboratory values, and ECG; clinically acceptable PE includes evidence of moderate to severe plaque PsO
* Diagnosis of plaque PsO for at least 6 months
* Moderate to severe plaque PsO defined by:
* A minimum PASI score of ≥ 10
* Psoriasis involving ≥ 10% of the Body Surface Area (BSA)
* Additional inclusion criteria apply
Exclusion Criteria:
Parts A - Healthy Volunteers:
* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
* Additional exclusion criteria apply
Part B - Psoriasis Subjects:
* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Recent or on-going infection(s)
* Underlying condition(s) that predisposes the subject to infections
* Guttate, pustular, or other non-plaque forms of PsO
* Evidence of skin conditions other than PsO (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years
* Additional exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01094093
Study Brief:
Protocol Section:
NCT01094093