Psoriasis Vulgaris
Conditions
Interventions
Tildrakizumab will be administered subcutaneously following the package insert instructions: 100 mg at the initial dose, followed by another dose after 4 weeks, and then every 12 weeks thereafter. The
Sponsors
Yamazaki Fumikazu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients diagnosed with psoriasis vulgaris who have received sufficient explanation about other treatment options other than the study drug (tildrakizumab) and have agreed to participate in this study using the study drug. (2)Patients aged 18 years or older at the time of obtaining consent. (3)Patients with a BSA of 10% or more who have not achieved sufficient efficacy with existing systemic therapy, including phototherapy or patients with refractory rashes.
Exclusion criteria
Exclusion criteria: (1)Patients with severe infections. (2)Patients with active tuberculosis. (3)Patients with a history of hypersensitivity to any components of the investigational drug. (4)Pregnant patients or patients who may be pregnant. (5)Lactating patients. (6)Patients who may be treated with biologics other than the study drug or systemic oral psoriasis drugs during the study period. (7)Patients participating in other clinical trials involving medical devices or interventional clinical studies. (8)Other patients deemed inappropriate as study subjects by the responsible physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sPGA (0/1) achievement rate at 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change from baseline in PASI score at weeks 4, 16, 28 and 52 (2) PASI 75 /90 /100 achievement rate at weeks 16, 28 and 52 (3) Percentage of sPGA (0 /1) attainment at weeks 16, 28 and 52 (4) DLQI (0 /1)attainment rate at weeks 16, 28 and 52 | — |
Contacts
Public ContactFumikazu Yamazaki
Tokai University Hospital
Outcome results
None listed