psoriasis vulgaris
Conditions
Interventions
1) Blood sample collection
2) Skin Biopsy
3) Prohibited concomitant therapy
The following treatments are prohibited until week 12 after obtaining sign to ICF.
Topical therapies that s affect psoriasis
Sponsors
Morita Akimichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) have a diagnosis of psoriasis vulgaris (a patient should be diagnosed with psoriasis and prescribed guselkumab for the treatment by clinical physician, which means the PI/SI has made decision for the psoriasis patients per best practices; hence, the patient received treatment of guselkumab) 2) must be a Japanese male or female of 20 or more years of age, inclusive, at the time of obtaining consent. 3) must have a PASI score of >10 (moderate to severe), at the time of obtaining consent or at week 0 (baseline). 4) must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. 5) are considered eligible according to the following tuberculosis (TB) screening criteria, as a usage guidance of biological treatment have no history of latent or active TB before screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first administration of guselkumab, or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of guselkumab. It is the responsibility of the PI to verify the adequacy of previous anti-tuberculosis treatment and provide appropriate documentation. have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of guselkumab. within 2 months before the first administration of guselkumab, have a negative IRGA test result, or have a newly identified positive IGRA test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of guselkumab. NOTE: IGRA test are not required at screening for participants with a history of latent TB with ongoing treatment or documentation of having completed adequate treatment; participants with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB. have a chest radiograph (posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of guselkumab and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
Exclusion criteria
Exclusion criteria: 1) has any prior experienced biologic therapy 2) is participating in a clinical trial with an investigational agent (ie, nonmarketed agent) or in any other interventional clinical trial except this study. 3) is diagnosed to have a serious infection. 4) has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients (refer to the package insert). 5) is scheduled to take any disallowed therapies noted in "Prohibited concomitant therapy or Restriction for concomitant therapy", during the applicable period. 6) any condition for which, in the opinion of the PI/SI, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to determine the proportion of: Treg subsets (aTreg + rTreg)/Th17, and DC subsets in each skin and blood sample by 12 weeks of the guselkumab therapy from baseline according to PASI score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Until 12 weeks through the guselkumab administration time course, the secondary endpoints are aimed to: 1) Validate to Th17 differentiation 2) Change in cytokine expression profiles 3) Change in mRNA expression | — |
Contacts
Public ContactAkimichi Morita
Nagoya City University Hospital
Outcome results
None listed