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 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT01999868
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of plaque psoriasis for at least 6 months
* Baseline Psoriasis Area and Severity Index (PASI) score \>= 12
* \>=10% body surface area psoriasis involvement
* Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial
* Ability and willingness to provide informed consent and comply with study requirements
Exclusion Criteria:
* Non-plaque forms of psoriasis
* Grade 2 or 3 moderate to severe psoriatic arthritis not adequately managed with non-steroidal anti-inflammatory drugs (NSAIDs)
* Myocardial infarction, unstable angina, cerebrovascular accident, or other significant cardiovascular event within the previous one year
* Chronic obstructive pulmonary disease (COPD)
* Comorbid condition that requires regular systemic corticosteroid treatment
* History of malignancy, except treated basal cell skin carcinoma
* Treated basal cell skin carcinoma within the previous 5 years
* Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study
* History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections
* Evidence of infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
* Positive QuantiFERON-TB Gold test. Purified Protein Derivative (PPD) tuberculin test may be substituted for QuantiFERON-TB Gold test.
* Severe reaction or anaphylaxis to any human monoclonal antibody
* Any previous treatment with agents targeting Interleukin (IL)-12 or IL-23, including ustekinumab
* Any previous treatment with abatacept
* Treatment with biologic agents within previous 3 months, including adalimumab, etanercept, and infliximab
* Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks
* Topical psoriasis treatment within previous 2 weeks, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar
* Investigational study medication within previous 6 months
* Liver function test (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], or alkaline phosphatase) results that are \>/= 2x the upper limit of normal (ULN).
* Serum creatinine \>= 2x the ULN.
* Any of the following hematologic abnormalities, confirmed by repeat test at least 1 week apart:
1. White blood count \<3,000/μL or \>14,000/μL;
2. Lymphocyte count \<1,000/μL;
3. Neutrophil count \<1,500/μL;
4. Platelet count \<150,000 /μL; or
5. Hemoglobin \<10 g/dL.
* Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use FDA-approved method of birth control
* Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the 6 weeks before enrollment
* BCG (Bacillus Calmette-Guérin) vaccine one year prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01999868
Study Brief:
Protocol Section:
NCT01999868