EUCTR2020-000067-23-FR
Active, not recruiting
Phase 1
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Polyneuron Pharmaceuticals AG
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 80 years, male and female.
- •Patient with a confirmed diagnosis of monoclonal IgM associated with MGUS with anti\-MAG activity (titer of \> 10’000 BTU) and demyelinating neuropathy defined by electrophysiological criteria according to EFNS/PNS PDN guideline, 2010\.
- •Clear clinical signs of disability: with at least ONLS \= 2 in lower extremities.
- •Inflammatory Neuropathy Cause and Treatment (INCAT) sensory sum score \=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
Exclusion Criteria
- •Patients with total serum IgM levels \>30 g.
- •Hematological malignancy, prior malignancy of any organ system (except BCC)
- •Prior immunosuppression: No IVIG in previous 3 months, no previous cyclophosphamide or biologicals in prior 6/12\.
- •Other neurological, neuromuscular, rheumatologic or orthopedic condition with significant impact on the capabilities of walk preventing evaluation of neurological scores
Outcomes
Primary Outcomes
Not specified
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