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NCT02428309 · ClinicalTrials.gov registry record · Phase 1
Autologous Polyclonal Tregs for Lupus
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02428309 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1 participants.
The verdict
NCT02428309, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus. Targeting cutaneous disease offers the ability to control background therapy, readily detect clinical effects, and perform research analyses not only in blood but also skin. Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support dose selection for a future larger efficacy trial in lupus.
Interventions
- BIOLOGICAL Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-08-27 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02428309
The ClinicalTrials.gov registry entry for NCT02428309 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells is the first listed.
NCT02428309 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02428309 about?
NCT02428309 is a clinical study titled "Autologous Polyclonal Tregs for Lupus". The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus. Targeting cutaneous disease offers the ability to control background therapy, readily detect clinical effects...
What is the current status of trial NCT02428309?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-08-27. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT02428309?
The interventions under investigation include: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02428309?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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