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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Panzyga IVIG — DRUG
  Immune Globulin Infusion 10% (Human)
• Placebo — DRUG
  0.9% NaCl prepared as the calculated dose equivalent volume to IVIG.

Study Details

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.

Key Dates

Start date

Dec 15, 2023

Status verified

Aug 2025

Primary completion

Aug 27, 2027

Completion

Feb 28, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (IVIG)
  Patients in the treatment arm will receive 2g/kg IVIG every 4 weeks (over 2 days, 1g/kg dose on Day 1 and 1g/kg dose on Day 2) for 24 weeks (6 doses total).
• Placebo Comparator: Placebo
  Patients in the placebo arm will receive 0.9% NaCl infusions on the same schedule as the active treatment group (Day 1 and Day 2 every 4 weeks for 24 weeks total, (6 doses).

Primary Outcome Measure

quantified change in intraepidermal nerve fiber density (IENFD) [ Time Frame: Week 24 ]

Central Contacts

• Anna Pham
  8475034344
  [email protected]
• May Aunaetitrakul
  8475702570

Locations (1)

Find similar trials in Glenview, IL

Related Studies

• Detection of Small Fiber Neuropathy Using Skin Properties
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts