NL-OMON49059
Completed
Not Applicable
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients. - PN-1007-001
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- anti-MAG neuropathy
- Sponsor
- Polyneuron Pharmaceuticals AG
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Written informed consent.
- •\- 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.
Exclusion Criteria
- •\- Patients with total serum IgM levels \>30 g.
- •\- Hematological malignancy (e.g. known multiple myeloma or confirmed
- •Waldenström's macroglobulinemia based on bone marrow analysis).
- •\- Patients with any history of malignancy of any organ system (other than
- •localized basal cell carcinoma of the skin), treated or untreated, within the
- •past 5 years, regardless of whether there is evidence of local recurrence or
- •metastases.
- •\- Previous immunosuppressive treatment with intravenous immunoglobulin (IVIG)
- •or apheresis/plasmapheresis in the preceeding 3 months, and/or cyclophosphamide
- •and biologicals (e.g. rituximab): in the preceeding 6 months prior to enrolment.
Outcomes
Primary Outcomes
Not specified
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