April 17, 2008

A Phase I, Randomized, Double-blind, Placebo-controlled, Escalating Single- and Multiple-dose Study of the Safety, Tolerability, and Pharmakokinetics of RhuMab IFN alpha in Adults with Systemic Lupus Erythematosus

IRB Number: 27058

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 A. Kirou, MD

Co-Investigators

Jessica R. Berman, MD
Stephen DiMartino, MD
Horatio Wildman, MD

Summary

The study is sponsored by Genentech, Inc.  The experimental drug is called rhuMAb interferon alpha. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how long the study drug stays in your blood) of rhuMAb IFNalpha for the treatment of systemic lupus erythematosus (SLE) in adults with SLE. The study will have two stages:  a single dose and follow up period (Stage I) and a monthly dose and follow-up period (Stage II).
 
Women who are pregnant or nursing a child may not participate in this study.  There may be other reasons why you cannot participate in this research study.  Your study doctor or study staff will discuss these with you.
 
Interferon alpha is a protein produced by many different cells in your body.  One of its many roles is helping the body defend itself against viral infections.  Studies have shown that IFNalpha (one of three major classes of interferon) is produced in excessive amounts in some patients with SLE, and it is believed that IFNalpha may contribute to the development of SLE. rhuMAb IFNalpha has never been given to humans before.  It has been given to animals (mice, rats, and monkeys) in non-clinical trials. rhuMAb IFNalpha is an antibody (a substance the body makes as part of an immune response) that has been designed to specifically bind to IFNalpha and make it inactive.  rhuMAb IFNalpha is being developed as a possible treatment for SLE and other diseases in which increased amounts of interferon may be involved.  The sponsor of this study is developing rhuMAb IFNalpha as a possible treatment to reduce the symptoms associated with SLE or other related diseases.
 
This is a randomized study, which means you will be assigned by chance to receive either rhuMAb IFNalpha or placebo (a substance that looks like rhuMAb IFNalpha but does not contain active drug).  In this study, there is a 4 out of 5 (80%) chance that you will receive rhuMAb IFNalpha and 1 out of 5 chance to receive placebo.
 
Approximately 34 study visits are required during the screening, treatment, and follow-up periods of this study.  You may have additional study visits if you are asked to return for blood tests between the follow-up period after the first dose and the monthly dose period.

Inclusion/Exclusion Criteria

Patients with stable or mildly active lupus will be considered.

Contact Information

Roland Duculan
Duculcanr@hss.edu
212.774.2967