Safety and Efficacy of Secukinumab in Mild Psoriasis

Psoriasis is an immune-mediated disease of the skin that, even in mild disease, increases the
risk of comorbidities such as cardiovascular disease and metabolic derangements. Mild
psoriasis tends to be treated with topical drugs, while moderate-to-severe disease is
optimally treated with systemic immune modulators. However, the treatment of "mild" psoriasis
needs to be re-thought because recent studies have revealed that mild psoriasis is
characterized by stronger expression of pathogenic molecules, such as interleukin (IL)-17A,
and higher numbers of T cells in the skin, compared to severe psoriasis. A key distinction
between mild and severe psoriasis is now discovered to be the higher expression of negative
immune regulatory genes in mild lesions. Therefore, targeted immune therapy with anti-IL-17A,
which is highly effective in severe psoriasis, might be equally (or even more) effective in
mild disease. Also, restoration of immune tolerance might be more easily achieved in mild
disease. Thus, short-term anti-IL-17A treatment of mild psoriasis might prevent the
recurrence and eventually cure the disease. The aim of study is to test this hypothesis by
exploring whether 3 months or 6 months of anti-IL17A treatment will prevent relapses after
medication has been discontinued in mild psoriasis patients.

Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed

2. 18 years of age or older

3. Chronic plaque-type psoriasis for at least 6 months

4. Negative PPD (negative chest w-ray if positive) or negative QuantiFERON-TB Gold

5. Have a PASI between 6 and 12 and Body Surface Area (BSA) affected by plaque-type
psoriasis less than 10% at screening and baseline

6. Willing to wash off steroid creams and ultraviolet B light (UVB) therapy for 2 weeks
prior to the baseline visit

Exclusion Criteria:

1. Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular)

2. Has previously received Secukinumab or other biologics

3. History of Inflammatory Bowel Disease (IBD)

4. History of Rheumatoid Arthritis

5. Use of topical treatments for psoriasis, including steroids, vitamin D derivatives,
vitamin A derivatives, salicylic acid, tar (except moisturizers) and/or ultraviolet A
light (UVA)/UVB phototherapy within the last 2 weeks (if these have used them, the
participant needs to wash off of them for at least 2 weeks after signing consent prior
to baseline)

6. Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months
following the last administration of study drug

7. Has recently received or is planning to receive a vaccination while on the study

8. HIV positive

9. Chronic untreated hepatitis C, positive hepatitis B surface antigen and acute
hepatitis A infection

10. Known tuberculosis (TB) or evidence of TB infection. Subjects with a positive
QuantiFERON; TB test or a positive purified protein derivate (PPD) skin test result
may participate in the study if further work up (according to local
practice/guidelines) establishes conclusively that the subject has no evidence of
active TB.

11. Any severe, progressive or uncontrolled medical condition at screening that in the
judgment of the investigator prevents the subject from participating in the study.