An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis

This study is planned with the primary objective of developing a database containing
patient-reported information that may be used to understand and increase awareness of the
impact that moderate-to-severe plaque psoriasis can have on both daily life and life in
general from a patient's perspective. This is a multicenter observational (no drug given to
the patient) patient narrative study. The duration of study is 16 weeks and includes adult
patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or
systemic therapy. The study investigators are dermatologists who treat patients with
moderate-to-severe plaque psoriasis. The study includes a screening visit 2 weeks before
Week 0 (baseline). Patients will be evaluated at screening for current or peak historical
physician's global assessment (PGA) response (range 0-5). Patients will provide narratives
at the Week 0 (baseline) visit and may add additional information at an interval visit or at
the end of the study on Week 16. Photography will be performed at Week 0 and at the end of
study at Week 16. Additional photographs will be taken if there is any change in disease
status (e.g., disease improvement or worsening, change in treatment) occurring prior to the
end of the study. Between Week 0 and Week 16, patients may return to the study site for 1
interval visit at the first clinically significant change in disease status, if applicable.
The Week 16 final assessment may be conducted as a telephone follow-up for patients who have
had an interval visit between Week 0 and Week 16. If the patient did not return to the study
site for an interval visit, the patient will return to the study site for a visit at Week
16. All assessments specified for the interval visit will be performed at Week 16. All
patients will have the following data collected: PGA score, area of body involved, body
surface area percent (BSA%, calculates percent of body surface area affected with
psoriasis), Psoriasis Area and Severity Index (PASI) de-identified photographs, adverse
events, and patient narratives. The information will be collected de-identified. Study
materials (e.g., demographic and disease characteristic forms, narratives, and photographs)
will be coded using a unique patient identification (ID) number. Only de-identified
information will be available to the Sponsor and related study personnel.

Inclusion Criteria:

Adult male and female patients having diagnosis of plaque psoriasis for at least 6 months
prior to screening

- Patients who are candidates for or are currently receiving the following: a.
conventional systemic agents (eg, MTX, acitretin, cyclosporine, fumarates, or
systemic psoralens plus ultraviolet A light [PUVA]), b. topical therapy and/or
phototherapy (and are eligible for, but are not currently receiving oral systemic or
biologic therapy), c. biologic therapy for moderate to severe plaque psoriasis

- Have a peak historical or current physician's global assessment (PGA) of greater than
or equal to 3 (range 0-5)

- Patients must have the ability to read and speak English

- Patients must reside in the US.

Exclusion Criteria:

Patients with guttate, erythrodermic, or pustular psoriasis (all are various types of
psoriasis)

- Patients with serious concomitant illness that could require the use of systemic
corticosteroids or otherwise interfere with the patient's participation in the trial