A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

• •Subject has a clinical diagnosis of moderate to severe plaque psoriasis for 6 months or longer with at least 5% or greater Body Surface Area (BSA) affected with plaque psoriasis
• •Subject must be a candidate for phototherapy and/or systemic therapy
• •Subject must agree to avoid prolonged exposure to the sun and avoid the use of tanning booths or other ultraviolet light sources during the study
• •Female subject must be either:
• •* post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
• •* premenarchal prior to Screening, or
• •* documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening), or
• •if of childbearing potential, must have a negative serum pregnancy test at Screening and if sexually active must be using highly effective contraception. All sexually active subjects will be required to use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• •Female subject must not be lactating and must not be breastfeeding at Screening or during the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• •Female subject must not donate ova starting at Screening and throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• •Male subject and their female spouse/partners who are sexually active must be using highly effective contraception1 consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• •Male subject must not donate sperm starting at Screening and throughout the study period and for at least 28 days \[or 5 five half lives of the study drug whichever is longer\] after final study drug administration.
• •Highly effective contraception is defined as:
• •* Established use of oral, injected or implanted hormonal methods of contraception.
• •* Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• •* Barrier methods of contraception: Condom alone or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
• •Subject must be willing and able to comply with the study requirements, including prohibited concomitant medication restrictions.