Actively Recruiting
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
Led by Endeavor Health · Updated on 2026-01-09
20
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
Sponsors
E
Endeavor Health
Lead Sponsor
O
Octapharma USA, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Clinical and biopsy evidence of pure small fiber neuropathy confirmed within 12 months
- Elevated or abnormal autoantibodies to TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 measured within 12 months
- Baseline pain score of 4 or higher on a visual analogue scale
- Baseline Utah Early Neuropathy Scale score of 4 or higher
- Small Fiber Neuropathy Screening List score of 11 or greater
- Non-pregnant, non-lactating females; females of reproductive potential must use two forms of contraception or abstain from heterosexual sex during treatment
You will not qualify if you...
- Any other known cause for small fiber neuropathy besides elevated TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 autoantibodies
- Severe musculoskeletal conditions that prevent proper assessment
- Evidence of large fiber polyneuropathy confirmed by electromyography or nerve conduction study
- Severe heart, kidney, liver disease, or HIV infection
- History of deep vein thrombosis within the past year or pulmonary embolism ever
- Known significant IgA deficiency with antibodies to IgA
- History of severe allergic reaction to immunoglobulin or blood products
- Known blood hyperviscosity or hypercoagulable states
- Use of IgG products within six months before enrollment
- History of drug or alcohol abuse within the past five years
- Unable or unwilling to comply with study protocol or understand it
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
Research Team
A
Anna Pham
CONTACT
M
May Aunaetitrakul
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here