Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Subjects with a chronic moderate to severe plaque-type psoriasis for at least 6months (as determined by subject interview and confirmation of diagnosis throughphysical examination by Investigator).

2. Subjects must have moderate to severe nail psoriasis at Screening and Baseline,defined by:

• mNAPSI score of ≥20.

• ViSENPsO ≥3

3. Subjects must have moderate to severe plaque psoriasis at Screening and Baseline,defined by:

• s-PGA score of at least 3.

• Body Surface Area (BSA) involvement of ≥10%.

• PASI ≥12

4. Subjects must be considered candidates for systemic therapy, meaning psoriasisinadequately controlled by topical treatments (corticosteroids), and/orphototherapy, and/or previous systemic therapy.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. Subjects who have predominantly non-plaque forms of psoriasis, specificallyerythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, ormedication-exacerbated psoriasis, or new-onset guttate psoriasis.

2. Subjects with ongoing inflammatory skin diseases other than psoriasis or any otherdisease affecting the fingernails, which may potentially confound the evaluation ofstudy treatment.

3. Subjects with fungal nail infection should be excluded from the study. Subjects inwhom the Investigator suspects a fungal nail infection in addition to nail psoriasisshould have scrapings sent for direct microscopy and fungal culture. If fungalculture or direct microscopy of nail scrapings turns out to be positive for fungalinfection, the subject should be excluded from the study. At the discretion of theinvestigator, Periodic Acid-Schiff (PAS) staining for nail clippings could also beconsidered to rule of fungal infection of the nails. Direct microscopy or fungalculture are not required if fungal infection is diagnosed in PAS staining.

4. Subjects with any previous use of tildrakizumab or other IL-23/Th-17 pathwayinhibitors, including p40, p19 and IL-17 antagonists for psoriasis.

5. Subjects with known history of allergy or hypersensitivity to any of the inactiveingredients of the Tildrakizumab or placebo formulations.