Purpura, Thrombotic Thrombocytopenic Clinical Trial
Official title:
A Phase II Pilot Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics and Pharmacokinetics of IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients With Low ADAMTS13 Activity
The main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single intravenous dose of IdeS.
Immunoglobulin G-degrading enzyme of Streptococcus pyogenes (IdeS) is an IgG specific
endopeptidase which cleaves IgG molecules and efficiently neutralizes Fc-mediated activities.
IdeS-mediated IgG degradation constitutes a novel therapeutic principle for the treatment of
IgG-driven human diseases.
In addition to assessing the safety and tolerability of IdeS the study will also assess the
efficacy of IdeS to significantly increase the ADAMTS13 activity and decrease the
anti-ADAMTS13 antibody levels in patients diagnosed with asymptomatic antibody-mediated TTP
with low ADAMTS13 activity.
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