First in human study to test the safety and preliminary efficacy of PPSGG, an antibody catcher in patients with anti-MAG neuropathy

Phase 1

• Conditions: anti-MAG neuropathy; MedDRA version: 21.1Level: LLTClassification code 10066137Term: Anti-MAG neuropathySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000067-23-FR
• Lead Sponsor: Polyneuron Pharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-13
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

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
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)
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified