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NCT02271165 · ClinicalTrials.gov registry record · Early Phase 1
Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study
A Early Phase 1 study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT02271165: Clinical Trial Early Phase 1 study, sponsored by Thomas Jefferson University.
NCT02271165 is a Early Phase 1 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02271165, a Early Phase 1 study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis. Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body) in patients with primary immunodeficiency. At present, patients with steroid resistant dermatomyositis can only be treated with IVIg (The healthy antibodies in IVIG can block the damaging antibodies that attack muscle and skin in dermatomyositis) treatment. An evaluation can then be made to see if SCIg is a suitable replacement and exerts immunomodulatory effect on complement antibodies.
Primary Outcome
The primary outcome is a change in strength (based on MRC sumscores) from baseline (enrollment) to the mean change at weeks 16, 20, 24 and 28.
Interventions
- DRUG Immunoglobulin (Hizentra)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-11 |
| Est. Completion | 2017-03-02 |
| Phase | Early Phase 1 |
Why NCT02271165 stopped before completion
NCT02271165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Immunoglobulin (Hizentra) is the first listed.
NCT02271165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02271165 about?
NCT02271165 is a clinical study titled "Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study". The purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin SCIg in the form of Hizentra (Immune globulin Subcutaneous) in patients with Dermatomyositis. Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobul...
What is the current status of trial NCT02271165?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2014-11. Estimated completion is 2017-03-02.
What interventions are being tested in trial NCT02271165?
The interventions under investigation include: Immunoglobulin (Hizentra) (DRUG).
Who is sponsoring clinical trial NCT02271165?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02271165's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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