Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea

Rosacea is a common inflammatory skin disease affecting up to 10% of adults. Despite this,
the etiology of rosacea is unclear, although there may be a genetic predisposition (Chang et
al., 2015). Currently, there is no cure. Rosacea can lead to scarring, itching, burning, and
is associated with anxiety and depression (Moustafa et al., 2015), significantly affecting
quality of life.

Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A) that is involved in
inflammation. When IL-17A is bound to secukinumab, it cannot bind to its receptor, thereby
inhibiting its ability to feed the inflammatory response. In clinical trials, secukinumab has
been effective for moderate to severe psoriasis (Blauvelt et al., 2015). Recently, human data
from all types of rosacea have shown Th1/Th17 polarization profile of the T-cell response,
suggesting that anti-IL-17 therapy may be beneficial for rosacea (Buhl et al., 2015). Hence,
secukinumab could be effective against rosacea. This proposal is a proof-of-concept study to
use secukinumab in open label design for moderate to severe papulopustular rosacea.

Inclusion Criteria:

- 1) moderate to severe papulopustular rosacea defined clinically using the grading
system of Wilkin et al. (2004) as having at least ten lesions (either papules or
pustules) on face at time of enrollment 2) age 18 years or greater willing and able to
understand and sign informed consent form

Exclusion Criteria:

- 1) known hypersensitivity to secukinumab 2) topical or oral anti-rosacea medication
usage for 28 days prior to enrollment 3) active Crohn's disease, as secukinumab may
exacerbate this disease 4) active infection including tuberculosis, hepatitis B or C,
human immunodeficiency virus 5) participants with latent tuberculosis will need to
have treatment initiated prior to starting study drug 6) pregnant or lactating 7)
active and/or uncontrolled medical conditions that may interfere with study procedures
or obscure rosacea assessment such as cutaneous lupus 8) use of retinoids within past
3 months of enrollment 9) use of antibiotics within 4 weeks of enrollment 10) use of
light based or laser treatment to face within 8 weeks of enrollment 11) use of topical
or systemic steroids within 4 weeks of enrollment 12) acne conglobate, acne fulminans,
chloracne, severe acne requiring systemic treatment