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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT03818035
Eligibility Criteria:
Inclusion Criteria:
* Has a disease duration of plaque psoriasis of either less than or equal to (\<=2) years or (greater than (\>2) years calculated from date at which first symptoms \[plaque\] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration \<=2 years
* Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score \>10 or affected body surface area (BSA) \>10%) and additionally a Dermatology Life Quality Index (DLQI) score \>10 at baseline (week 0)
* Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
* Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
* Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
Exclusion Criteria:
* Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab \[MK3222\], risankizumab \[BI-655066\])
* Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug.
* Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
* Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
* Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03818035
Study Brief:
Protocol Section:
NCT03818035