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

Brief description of study

Lupus is an autoimmune disease, which means that your immune system attacks the tissues and organs of your own body. Lupus can cause fever, fatigue, joint pain, rash (redness of the skin), sensitivity to sunlight, as well as other symptoms, and may lead to inflammation and organ damage. This study is done to see if anifrolumab (MEDI 546) is safe and well tolerated for up to 156 weeks (3 years). Anifrolumab (MEDI 546), the drug being tested in this study, is a man-made human monoclonal antibody that blocks the actions of type I interferons. Antibodies are a type of protein that exists naturally in the body and that help you to fight infections. A monoclonal antibody is a protein that is artificially made in a laboratory, and acts like an antibody found normally in the body. This study will evaluate one dose of anifrolumab (MEDI 546) to see how it compares with placebo (an inactive substance that looks identical to the drug being tested). The study will invite participants who have completed a prior phase 3 study comparing anifrolumab and placebo (MEDI-546).


Clinical Study Identifier: s18-00224
ClinicalTrials.gov Identifier: NCT02794285
Principal Investigator: David H. Goddard.


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