Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris

Exclusion Criteria

• •1. A diagnosis of Acne conglobata, acne fulminans, secondary acne, severe nodulocystic acne requiring treatment with isotretinoin, or other dermatologic conditions requiring interfering phototherapy, topical, or systemic treatment.
• •2. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
• •3. Men with facial hair that would interfere with assessments
• •4. 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.
• •5. Hemoglobin \<10.0 g/dL, or WBC \<3.0 x 103/mm3, or platelet count \<125 x 103/mm3, or creatinine \> 1.5mg/dL, or AST/ALT \>2 x ULN, or alkaline phosphatase \>2 x ULN
• •6. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
• •7. 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.
• •8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
• •9. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
• •10. Infectious disease:
• •* CRP \>30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
• •11. Immunodeficiency
• •12. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
• •13. Receipt of a live (attenuated) vaccine within 1 month prior to Screening
• •14. Major surgery within 28 days prior to Day 0
• •15. Participation in an investigational drug or device trial within 30 days prior to Screening