CLINICAL TRIAL REVIEW

A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-Inflammatory Therapeutic Antibody (RA-18C3) in Subjects With Moderate to Severe Acne Vulgaris
Sponsored by XBiotech, Inc., this study is a 91-day, phase II, open-label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. The primary outcome measure is safety and tolerability.Sponsored by XBiotech, Inc., this study is a 91-day, phase II, open-label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. The primary outcome measure is safety and tolerability.

Inclusion Criteria: Participants aged 18 to 30 years with moderate to moderately severe inflammatory acne vulgaris are eligible. A fourweek washout period for topical and oral antibiotic treatment and topical retinoids is required. Participants must have a negative pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize 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. Subjects must weigh 27 kg or greater and must sign the Institutional Review Board (IRB) approved informed consent.

Exclusion Criteria: Participants cannot have 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. Participants cannot have had treatment with any biologicals or investigational agents within the last 4 weeks. Men with facial hair that would interfere with assessments are ineligible. A 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 that, in the opinion of the investigator, would put the subject at risk by participation in the protocol are grounds for exclusion. Participants cannot have hemoglobin less than 10.0 g per dL, or WBC less than 3.0 x 103 per mm3, or platelet count less than 125 x 103 per mm3, or creatinine greater than 1.5 mg per dL, or AST/ALT greater than 2 x ULN, or alkaline phosphatase greater than 2 x ULN. Participants cannot have known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody, a 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. Participants cannot have a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies; a history of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA); infectious disease, immunodeficiency, pregnancy or potential pregnancy, or breastfeeding; receipt of a live (attenuated) vaccine within 1 month prior to screening; or major surgery within 28 days prior to Day 0 or participation in an investigational drug or device trial within 30 days prior to screening.

A Pilot Study To Evaluate the Efficacy of Vytorin (Simvastatin + Ezetimibe) In the Treatment of Alopecia Areata
Sponsored by the University of Miami, this study will evaluate the efficacy of oral simvastatin plus ezetimibe (Vytorin) in treating alopecia areata in subjects aged 18 years and older. The investigators hypothesize that Vytorin may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory process may help in permitting hair regrowth in those subjects. The primary outcome measure is at least 20% hair regrowth within 6 months time.

Inclusion Criteria: Male and female participants, aged 18 years or more, with 40% to 80% hair loss, with a clinical diagnosis of alopecia areata, are eligible.

Exclusion Criteria: Participants younger than 18 years of age, who are pregnant, nursing, or planning to be pregnant, will be excluded. Participants with kidney, liver, or muscle disease will be excluded, as will those who are allergic to lidocaine or to other study drugs, or presently participating in another clinical trial. Participants who have recently taken or are taking systemic corticosteroids, immunosuppressant agents, or any medication that may have interaction with Vytorin will be excluded. Participants cannot have used, within the past 2 weeks, any topical medication for the treatment of alopecia areata or have an ongoing hypothyroid problem that is not being treated.

Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pretreatment With Topical Tretinoin
Sponsored by Johns Hopkins University, this study aims to determine whether use of topical tretinoin can help prevent the common rash that patients often get while taking epidermal