Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis

Inclusion criteria

• Subjects 18 years of age or older
• Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions.
• Psoriasis area-and-severity index (PASI) score of ≥ 12
• Involvement of ≥ 5% of body-surface area
• For female subjects of childbearing age, a negative urine pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize adequate, double barrier contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion.
• Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed

Exclusion criteria

• Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• Treatment with conventional systemic psoriasis therapy within last 4 weeks
• Treatment with phototherapy within the last 4 weeks
• Topical psoriasis treatment with the last 2 weeks
• History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3, platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN
• Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
• History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
• Infectious disease:

CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening

• Immunodeficiency
• History of treatment with Tysabri or Raptiva
• Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
• Receipt of a live (attenuated) vaccine within 3 months prior to Screening
• Major surgery within 28 days prior to Day 0
• Participation in an investigational drug or device trial within 30 days prior to Screening