Incidence and prevalence of small-fiber neuropathy: a survey in the Netherlands.
Martine J H Peters, Mayienne Bakkers, Ingemar S J Merkies...
https://pubmed.ncbi.nlm.nih.gov/23997150Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04153422
Intravenous Immunoglobulin (IVIG) Treatment for Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies: A Double-Blind Placebo-Controlled Phase II Trial
Led by Endeavor Health · Updated on 2026-01-09
20
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the use of an intravenous immunoglobulin (IVIG) called Panzyga to treat patients with small fiber neuropathy (SFN), a condition that causes pain and nerve damage. This study focuses on patients with autoimmune SFN who have specific antibodies (TS-HDS, FGFR-3, or Plexin D1). While Panzyga is approved for other immune-related conditions, it has not yet been approved for SFN. The purpose is to see if Panzyga can improve nerve fiber density and reduce pain in these patients. Participants will be randomly assigned to receive either Panzyga IVIG or a placebo. Those in the treatment group will receive 2g/kg of IVIG every four weeks over two days (1g/kg on each day) for a total of six doses over 24 weeks. The placebo group will get saline infusions on the same schedule. This double-blind trial compares the effects of IVIG against placebo over six months. During the study, participants will undergo skin biopsies before and after treatment to measure nerve fiber density, which is the primary outcome after 24 weeks. Secondary assessments include pain ratings, disability scales, symptom questionnaires, and neurological exams at baseline and week 28. Patients will be monitored regularly to track symptoms and safety throughout the trial, which is expected to complete by February 2028.
CONDITIONS
Brief Title
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical and biopsy evidence of pure small fiber neuropathy with reduced nerve fiber density on skin biopsy within the last 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 who must use two forms of contraception or abstain from heterosexual sex during treatment
You will not qualify if you...
- Any other known cause of small fiber neuropathy besides the specified autoantibodies
- Severe musculoskeletal conditions preventing adequate assessment
- Evidence of large fiber polyneuropathy on nerve conduction studies
- Severe heart, kidney, liver disease, or HIV infection
- History of deep vein thrombosis within the past year or pulmonary embolism
- Significant IgA deficiency with antibodies to IgA
- History of severe allergic reactions to immunoglobulin or plasma products
- Blood hyperviscosity or other hypercoagulable conditions
- Use of IgG products within six months prior to enrollment
- History of drug or alcohol abuse within five years
- Inability or unwillingness to comply with the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive intravenous infusions of either IVIG or placebo every 4 weeks over 2 days for a total of 24 weeks.
6 treatment visits (in-person), each over 2 days
Follow-up
Duration - 4 weeks
Participants are assessed for changes in pain, disability, and neuropathy symptoms after treatment completion.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Endeavor Health
Glenview, Illinois, United States, 60026
Actively Recruiting
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Research Team
A
Anna Pham
M
May Aunaetitrakul
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kamran Darabi, Omar Abdel-Wahab, Walter H Dzik
https://pubmed.ncbi.nlm.nih.gov/16686841The Utah Early Neuropathy Scale: a sensitive clinical scale for early sensory predominant neuropathy.
J Robinson Singleton, Billie Bixby, James W Russell...
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N Souayah, R L Chin, T H Brannagan...
https://pubmed.ncbi.nlm.nih.gov/19049545Cryptogenic small-fiber neuropathies: Serum autoantibody binding to trisulfated heparan disaccharide and fibroblast growth factor receptor-3.
Todd D Levine, Jafar Kafaie, Lawrence A Zeidman...
https://pubmed.ncbi.nlm.nih.gov/31650561Small fiber neuropathy: Swiss cohort characterization.
Lorena M Bitzi, Dirk Lehnick, Einar P Wilder-Smith
https://pubmed.ncbi.nlm.nih.gov/34075618Associated conditions in small fiber neuropathy - a large cohort study and review of the literature.
B T A de Greef, J G J Hoeijmakers, C M L Gorissen-Brouwers...
https://pubmed.ncbi.nlm.nih.gov/29112785A Novel Autoantibody against Plexin D1 in Patients with Neuropathic Pain.
Takayuki Fujii, Ryo Yamasaki, Kyoko Iinuma...
https://pubmed.ncbi.nlm.nih.gov/30014510Intravenous immunoglobulin efficacy for primary Sjögren's Syndrome associated small fiber neuropathy.
Antoine Gaillet, Karine Champion, Jean-Pascal Lefaucheur...
https://pubmed.ncbi.nlm.nih.gov/31520801