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Summary: Investigators at seven sites in the United States and other sites around the world are recruiting 292 people with relapsing forms* of MS for a study of atacicept – an experimental immune-modifying drug delivered in injections under the skin – versus inactive placebo. For the purposes of this study, “relapsing forms of MS” would include individuals who experience repeated, acute attacks or relapses of symptoms, followed by periods of full or partial recovery. The study is sponsored by EMD Serono, Inc. in the United States and, in the rest of the world, by Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany.
Rationale: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Increasing evidence indicates that immune cells known as “B cells” play a role in this attack. Atacicept has been shown in animal models to affect several stages of B-cell development. Early studies in lupus and arthritis – diseases that also involve a misguided immune attack – have shown some potential for benefit. The drug has not been tested in multiple sclerosis.
Eligibility and Details: To be considered for participation, patients should be 18 to 60 years old with a diagnosis of a relapsing form of MS. Participants are being randomly assigned to receive one of three doses of atacicept or inactive placebo for 36 weeks, and are being followed until week 48. The primary objective of the study is to evaluate the effectiveness of atacicept in reducing inflammation as assessed by frequent MRI scans. Secondary objectives include safety.
Contact: Sites in the United States are in Arizona, Michigan, New Hampshire, North Carolina, Ohio, Pennsylvania, and Tennessee. For information on these sites, please see theatacicept listingin our clinical trials section. Information on sitesoutside the U.S.is also available.
Stony Brook University Hospital
101 Nicolls Road Stony Brook, NY 11794