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June 13, 2006

A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study To Evaluate Safety And Tolerability Of A Single IV Dose Of MEDI-545, A Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes

IRB Number: 26044

Institutional Review Board
Hospital for Special Surgery


The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos Kirou, MD

Co-Investigators

Jessica Berman, MD

Summary

Lupus Research Study

Systemic lupus erythematosus (SLE) is an autoimmune disease.  In autoimmune diseases, the patient’s own immune system attacks organs or systems of the body.  In SLE, multiple organs or systems of the body may be attacked, including the skin, joints, blood, and kidneys.

Although treatment of SLE has improved over several decades, the burden of the illness on patients remains considerable.  Patients and their families may experience economic hardship, disability, uncontrolled disease, and adverse effects of medications.  New and better treatments for SLE are urgently needed.

Hospital For Special Surgery/Dr. Kyriakos Kirou is seeking individuals with mild systemic lupus erythematosus (SLE) for possible participation in the LISA (Lupus Interferon Skin Activity) Study.  The purpose of the LISA Study is to evaluate the safety and tolerability of an investigational intravenous drug in patients diagnosed with mild SLE who also have lupus rash or skin lesions.

Participants will receive at no cost:

  • Study-related health exams

  • Lab tests

  • Reimbursement for expenses as applicable

This is a 3-month Phase I study targeting people diagnosed with mild SLE (systemic lupus erythematosus) who has active lesions.  The medication will be given IV once, lab tests and medical care will be conducted throughout the study period.  There will be approximately 14 visits for the study.  We are looking to find 3 people for this study.

Inclusion/Exclusion Criteria

Potential study volunteers must be 18 or older with lupus rash or skin lesions associated with a diagnosis of mild systemic lupus erythematosus (SLE).  Additional criteria apply.  Participation in the LISA Study includes as many as fourteen visits to a local physician’s office over a period of up to fourteen weeks.  Participants will undergo lab tests (blood and urine) and two skin biopsies during the course of the study.  Some study participants will receive placebo.

Contact Information

Kyriakos Kirou, MD
212.774.2967





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