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A Multicentre, Randomized, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterize the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

IRB Number: 2018-0567
not enrolling new patients

January 15, 2021

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the 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 or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

David R. Fernandez, MD, PhD
Jeffrey Zhang-Sun

Summary

Studies have shown that Type 1 Interferons are important contributors to autoimmune diseases such as systemic lupus erythematosus. The new investigational medical treatment anifrolumab has been shown to inhibit the biological activity of Type 1 Interferons. Anifrolumab may therefore be a novel and efficacious therapy for the treatment of systemic lupus erythematosus. This clinical trial aims to assess the long-term safety and effectiveness of intravenous anifrolumab as treatment for patients with systemic lupus erythematosus.

Inclusion/Exclusion Criteria

Not necessary as study is no longer recruiting.

Contact Information

Jeffrey Zhang-Sun
zhangsunj@hss.edu
212.774.2967