Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis

Inclusion Criteria

• Subjects should be 18 years or older at the time of signing the informed consent during the Screening visit.
• Subjects with a clinical diagnosis of chronic plaque psoriasis of at least 6 months (as determined by-subject interview and confirmation of diagnosis through physical examination by Investigator).
• Subjects must have moderate to severe plaque psoriasis of the scalp at Screening and at Baseline, defined by:
• Scalp Investigator Global Assessment (IGA) of ≥3
• Psoriasis Scalp Severity Index (PSSI) score of ≥12
• ≥30% or scalp surface area affected.
• Subject must have moderate to severe plaque psoriasis at Screening and Baseline defined by
• Physician Global Assessment for Skin (PGA-S) of at least moderate severity (score of ≥3 on a 5-pointer scale)
• PASI score of ≥12
• Body Surface Area (BSA) involvement of >10%
• Subjects must be considered candidates for systemic therapy, meaning scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
• Subjects has a negative evaluation for tuberculosis (TB) within 4 weeks before initiating study treatment, defined as a negative QuantiFERON® test. Subjects with a positive or 2 successive indeterminate. QuantiFERON® tests are allowed if they have all of the following:
• No history of active TB or symptoms of TB.
• A posterior-anterior chest radiogram (with associated report available at study center) performed within 3 months of Screening with no evidence of active TB (or of any other pulmonary infectious diseases).
• If prior latent TB infection (LTBI), must have history of adequate prophylaxis (per local standard of care).
• If presence of LTBI is established, then treatment according to local country guidelines must have been followed for 4 weeks prior to inclusion in the study.

A maximum of 2 QuantiFERON® tests are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.

• Subjects are unlikely to conceive, as indicated by at least one "Yes" answer to the following questions:
• Subject is a male.
• Subject is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception as per Appendix 7.
• Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (eg, condom) if not surgically sterile (ie, vasectomy).
• Subject is a surgically sterilized female or is documented to be postmenopausal. For contraceptive guidance see Appendix 7.
• For women of childbearing potential, a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to Day 1 and on subsequent visits at which study treatment doses are scheduled.
• Subjects must have results of a physical examination within normal limits or clinically acceptable limits to the Investigator prior to Day 1. The Investigator is encouraged to consult with the Medical Monitor (or appropriate designee) if there are questions regarding the significance of any out-of-range values.
• Subjects must be capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria

• Subjects who have laboratory abnormalities at Screening including any of the following:
• Alanine aminotransferase or aspartate aminotransferase ≥2.5 × the upper limit of normal
• Creatinine ≥2 × the upper limit of normal
• Serum direct bilirubin ≥1.5 mg/dL
• White blood cell count <3.0×103/μL
• Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
• Subjects who have predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly