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IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies

NCT04153422 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-09

No results posted yet for this study

Summary

This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga. Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency (PI) in patients 2 years of age and older; Chronic immune thrombocytopenia (ITP) in adults and Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It has not been approved by the FDA for use in SFN.

There is mounting evidence that Intravenous Immunoglobulin (IVIG) can cause pain reduction and improve objective nerve fiber densities on skin biopsies in great numbers in SFN patients. The primary outcome is quantified improvement in intraepidermal nerve fiber density (IENFD) on repeat skin punch biopsy after 6 months of IVIG treatment.

Conditions

  • Small Fiber Neuropathy
  • Autoimmune Small Fiber Neuropathy
  • Inflammatory Polyneuropathy
  • Immune-Mediated Neuropathy

Interventions

DRUG

Panzyga IVIG

Immune Globulin Infusion 10% (Human)

DRUG

Placebo

0.9% NaCl prepared as the calculated dose equivalent volume to IVIG.

Sponsors & Collaborators

  • Octapharma USA, Inc.

    collaborator UNKNOWN

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Lawrence Zeidman, MD, FAAN · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2027-08-27
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153422 on ClinicalTrials.gov