| Eligibility |
Inclusion Criteria:
- Diagnosis of PRP by clinical assessment
- Male age 18-99, willing to use a reliable form of birth control if sexually active
with a woman who is able to become pregnant.
- Female age 18-99; either of non-childbearing potential or of childbearing potential
who test negative for pregnancy and agree to use a reliable method of birth control or
remain abstinent during the study and for at least 12 weeks following the last dose of
guselkumab.
- Involved body surface area (BSA) = 10% at baseline (moderate-to-severe disease).
- Are a candidate for phototherapy and/or systemic therapy.
Exclusion Criteria:
- Willingness to travel to Oregon Health and Science University (OHSU) for all study
visits, or willing/able to participate in remote videoconferencing visits with access
to a computer with internet and webcam capabilities.
- Known malignancy or lymphoproliferative disease (except treated basal cell skin
cancer, treated squamous cell skin cancer, or treated cervical carcinoma in situ) for
at least 5 years.
- Active, untreated, acute or chronic infection, or immunocompromised to an extent that
such that participation in the study would pose an unacceptable risk to the subject.
- Positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
- Have latent or active untreated tuberculosis (TB), a positive QuantiFERON-TB Gold test
result, signs or symptoms of active TB on medical history or physical examination, or
close contact with a person with active TB who have not undergone evaluation or
treatment for TB. Those who are currently • Previous treatment with any agent that
targets the interleukin 23 p19 subunit specifically.
- Systemic treatment with prednisone in the last 2 weeks, or other systemic therapies or
phototherapy for PRP within the past 4 weeks or 5 half-lives prior to baseline,
whichever is longer. For biologic therapies, the specific washout periods used will
be: etanercept <28 days; infliximab, adalimumab, i
- Have a known allergy or hypersensitivity to any biologic therapy that would pose an
unacceptable risk to the subject if participating in this study.
- Have or intend to have a live vaccine within 3 months prior to baseline or 12 months
prior to baseline in the case of the Bacillus Calmette-Guerin (BCG) vaccine, or any
live vaccine during the course of study or within 3 months after the last
administration of study drug.
- Had any major surgery within 8 weeks prior to baseline or will require major surgery
during the study, that in the opinion of the investigator would pose an unacceptable
risk to the subject.
- Presence of significant uncontrolled cerebrovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders,
or abnormal laboratory screening values that, in the opinion of the investigator, pose
an unacceptable risk to the subject if participating • Have clinical laboratory test
results at screening that are outside the normal reference range of the population and
are considered clinically significant, or have any of the following specific
abnormalities: Neutrophil count <1500 cells/µL, white blood cell count <3500 cells/µL,
platelet count <100,000
- Women who are lactating or breastfeeding.
- Have any other condition that precludes the subject from following and completing the
protocol, in the opinion of the investigator.
- Are investigator site personnel directly affiliated with this study and/or their
immediate families (spouse, parent, child, or sibling).
- Are currently enrolled in, or discontinued from a clinical trial involving an
investigational product or non-approved use of a drug or device within the last 4
weeks or a period of at least 5 half-lives of the last administration of the drug,
whichever is longer, or concurrently enrolled in any other type of medical research
judged not to be scientifically or medically compatible with this study.
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