Efficacy, Safety and Pharmacokinetics of IgPro in Dermatomyositis

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:

  • Conditions:
    Dermatomyositis
  • Age: Between 18 Years - 99 Years
  • Gender: All
Updated on 17 Sep 2021. Study ID: 834652

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

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