Kantonsspital St.Gallen
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IgPro20_3007: RECLAIM

Andrea Rubbert Roth, Carina Hutz, Mira Bartz Batliner, Riana Peischl & Clelia Sasselli

abstract A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20
(Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
   
type of project clinical studies
status ongoing - recruiting phase
start of project 2020
end of project 2025
study design This is a phase 3, multicenter, randomized, placebo-controlled,
double-blind study of IgPro20 (subcutaneous immunoglobulin G
[SCIG]) treatment in adult subjects with dermatomyositis (DM)
with or without muscle weakness.
After Screening, subjects will be randomized to 1 of 2 treatment
sequences:
Sequence A: 0.5 g/kg IgPro20 for 24 weeks (Study Period 1)
followed by 0.5 g/kg IgPro20 for 28 weeks (Study Period 2)
- OR -
Sequence B: placebo for 24 weeks (Study Period 1) followed by
0.5 g/kg IgPro20 for 28 weeks (Study Period 2)
Subjects with demonstrated treatment benefit at the End
of Period 2 (EOP2) (Total Improvement Score [TIS] ≥ 20 points
at Week 49) will be eligible to continue long-term treatment with
IgPro20 for up to 3 years in Study Period 3.
responsible person Prof. Andrea Rubbert-Roth