A Multicenter Randomized Double-blind Placebo-controlled Parallelgroup Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants with Moderately to Severely Active Systemic Lupus Erythematosus

Brief description of study

The purpose of this study is to assess if a drug called dapirolizumab pegol (DZP), used in addition to standard systemic lupus erythematosus (SLE) medication, can improve disease symptoms over a period of 48 weeks. The researchers also want to see if DZP is safe for people with SLE. V8.0 sop-008565 in Dapirolizumab pegol is an investigational drug. This means it has not been approved by the US Food and Drug Administration (FDA). It is a part of a molecule commonly called an ‘antibody’. Antibodies are a group of proteins that can naturally be found in your body and that usually help your immune system (the body’s defense system) to fight infections. They do this by identifying a foreign molecule (also called antigen) and appropriately directing the immune response against it. Dapirolizumab pegol is using this mechanism by being directed against a molecule on the surface of certain cells of your immune system called CD40 ligand (CD40L), which is involved in communication within the immune system. By sticking to the CD40L molecule, DZP stops this communication. As a result, the inflammatory process which is ruled by this molecule is also stopped. The researchers want to see if this will help to reduce the inflammation in your body caused by SLE.


Clinical Study Identifier: s19-01637
ClinicalTrials.gov Identifier: NCT04294667
Principal Investigator: David H. Goddard.


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