CSL Behring is recruiting 126 participants for a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous immunogloblin) treatment in adult subjects with dematomyositis (DM). The primary objective of this study is to access the effectiveness of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM. These will be evaluated using a set of myositis disease assessment tools developed by the International Myositis Assessment and Clinical Studies Group (IMACS).
Hizentra is a form of immunogloblin, a solution made from human plasma that contains antibodies. Immunogloblin, often administered intravenously (IV), has been used successfully to treat myositis diseases. Hizentra is administered subcutaneously (SC), making it easier for the patient to give it to themselves. It is FDA approved for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder affecting the nerves, and primary immunodeficiency (PI), a group of chronic disorders in which the immune system does not function properly.
to see if you qualify to enroll as a participant in this clinical trial, contact the trial registration coordinator at 610-878-4000 or clinicaltrials@cslbehring.com.
Find more information about this trial here.
More information on other clinical trials for myositis can be found here.