A Study to Evaluate the Efficacy Safety and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin Hizentra) in Adults with Dermatomyositis (DM)

  • STATUS
    Enrolling By Invitation
  • participants needed
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Updated on 19 February 2024

Summary

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). Subjects will be randomized to 1 of 2 treatment sequences: Sequence A: 0.5 g/kg IgPro20 for 24 weeks followed by 0.5 g/kg IgPro20 for 28 weeks or Sequence B: placebo for 24 weeks followed by 0.5 g/kg IgPro20 for 28 weeks. Screening: about 2 months, 52-week treatment period. Duration of the study will be approximately 3.5 years. A sufficient number of subjects will be screened in order to randomize 126 subjects into the study. 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.

Details
Condition Dermatomyositis
Age 18years - 99years
Clinical Study IdentifierTBD
Last Modified on19 February 2024

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If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

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