Project
IgPro20_3007: RECLAIM
Ongoing - recruitment active · 2020 until 2025
Rubbert-Roth Andrea, Hutz Carina Liane, Bartz-Batliner Mira, Peischl Riana, Sasselli Clelia
Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Ongoing - recruitment active
Start Date
2020
End Date
2025
Financing
Industry
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.
Brief description/objective
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20
(Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)