Projekt
IgPro20_3007: RECLAIM
Laufend - Rekrutierung – laufend · 2020 bis 2025
Rubbert-Roth Andrea, Hutz Carina Liane, Bartz-Batliner Mira, Peischl Riana, Sasselli Clelia
Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Laufend - Rekrutierung – laufend
Start
2020
Ende
2025
Finanzierungsart
Industrie
Studiendesign
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.
Kurzbeschreibung/Zielsetzung
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20
(Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)