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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: Recruiting Phase 2 study of Small Fiber Neuropathy and Autoimmune Small Fiber Neuropathy, sponsored by Endeavor Health.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
3mm skin punch biopsy at 3 sites
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 |
What NCT04153422 shows while recruiting
NCT04153422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04153422's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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