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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05272150
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis \[PsA\]) for at least 6 months before the first administration of study drug
* Self-identify as non-white or non-caucasian
* Be a candidate for phototherapy or systemic treatment for psoriasis
* Have an involved body surface area (BSA) greater than or equal to (\>=) 10 percent (%), psoriasis area and severity index (PASI) \>=12, investigator global assessment (IGA) \>=3 at screening and at baseline (Cohort A), or have a scalp surface area \>=30%, psoriasis scalp severity index (PSSI) \>=12, scalp specific investigator global assessment (ss-IGA) \>=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
* Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention
Exclusion Criteria:
* Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
* Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05272150
Study Brief:
Protocol Section:
NCT05272150