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NCT01389895 · ClinicalTrials.gov registry record · Phase 1
Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01389895 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 1 participants.
The verdict
NCT01389895, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.
Interventions
- DRUG AMG 557
- DRUG AMG 557 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01389895
The ClinicalTrials.gov registry entry for NCT01389895 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 Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AMG 557 is the first listed.
NCT01389895 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01389895 about?
NCT01389895 is a clinical study titled "Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus". This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consi...
What is the current status of trial NCT01389895?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2011-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01389895?
The interventions under investigation include: AMG 557 (DRUG), AMG 557 Placebo (DRUG).
Who is sponsoring clinical trial NCT01389895?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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