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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01320293
Eligibility Criteria:
Inclusion Criteria:
* Must understand and voluntarily sign an informed consent form.
* Must be male or female and age 18-55 years at time of consent.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
* Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
* Negative PPD at Screening or 3 months earlier.
* Have not used any biologic treatment for psoriasis in the past 12 months.
Exclusion Criteria:
* Inability to provide voluntary consent
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Pregnant, trying to become pregnant or breastfeeding
* Prior diagnosis of coronary artery disease (CAD) or heart disease.
* Systemic fungal infection
* History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative \[PPD\] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
* History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
* Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
* Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
* History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
* Positive Hepatitis B Surface antigen at screening
* Malignancy or history of malignancy (except for treated \[ie, cured\] basal-cell skin carcinomas \> 3 years prior to screening)
* History of any demyelinating disorder such as multiple sclerosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01320293
Study Brief:
Protocol Section:
NCT01320293