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NCT04153422 · ClinicalTrials.gov registry record · Phase 2
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
A Phase 2 study of Small Fiber Neuropathy and Autoimmune Small Fiber Neuropathy, sponsored by Endeavor Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04153422 is a Phase 2 study of Small Fiber Neuropathy and Autoimmune Small Fiber Neuropathy that is actively recruiting participants, run by Endeavor Health. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04153422, a Phase 2 study of Small Fiber Neuropathy and Autoimmune Small Fiber Neuropathy, is actively recruiting participants, sponsored by Endeavor Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Placebo
- DRUG Panzyga IVIG
Study Locations (1)
Illinois
- Endeavor Health - Glenview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04153422
The ClinicalTrials.gov registry entry for NCT04153422 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Small Fiber Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04153422 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04153422 about?
NCT04153422 is a clinical study titled "IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies". 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 (...
What is the current status of trial NCT04153422?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2023-12-15. Estimated completion is 2028-02-28.
What conditions does trial NCT04153422 study?
This clinical trial studies the following conditions: Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy.
What interventions are being tested in trial NCT04153422?
The interventions under investigation include: Placebo (DRUG), Panzyga IVIG (DRUG).
Who is sponsoring clinical trial NCT04153422?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04153422 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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