EUCTR2020-000067-23-GBActive, not recruitingPhase 1
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Age between 18 and 80 years, male and female.
- •Patient with a confirmed diagnosis of monoclonal IgM associated with monoclonal gammopathy of undetermined significance (MGUS) with anti-MAG activity (titer of > 10’000 Bühlmann Titer units (BTU) and demyelinating neuropathy defined by electrophysiological criteria according to European Federation of Neurological Societies/Peripheral Nervous System paraproteinemic demyelinating neuropathy EFNS/PNS PDN guideline, 2010.
- •Clear clinical signs of disability: with at least ONLS = 2 in lower extremities.
- •Inflammatory Neuropathy Cause and Treatment sensory sum score (ISS) =2.
- •Adequate hepatic and renal function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
Exclusion Criteria
- •Patients with total serum IgM levels >30 g.
- •Hematological malignancy, prior malignancy of any organ system (except BCC)
- •Previous immunosuppressive treatment with intravenous immunoglobulin (IVIG) or apheresis/plasmapheresis in the preceeding 3 months, and cyclophosphamide and/or biologicals (e.g. rituximab): in the preceeding 6 months prior to enrolment
- •Other neurological, neuromuscular, rheumatologic or orthopedic conditions with significant impact on the capability of walking preventing evaluation of neurological scores
Investigators
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