Efficacy, Safety and Pharmacokinetics of IgPro in Dermatomyositis
Brief description of study
This is a phase 3, 56-week, multicenter, randomized, placebo controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM).
Key eligibility criteria: Adults with moderate to severe DM with failure of other therapies. Main study interventions: vital signs, weight, labs (safety + specialty), selective PKs, ECGs, home infusions of self-administered study drug (weekly for 52 weeks), patient diaries, clinical assessments, patient questionnaires, optional future research sub-study including genetic testing. Some of the patient and physician assessments will be administered by tablets. Subjects will receive materials (Crono pump) and instructions from the research staff for home-based self-administration of the study drug via subcutaneous infusions.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Dermatomyositis
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
17 Sep 2021.
Study ID: 834652