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NCT03451422 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03451422: Completed Phase 1 study, sponsored by Amgen.
NCT03451422 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03451422, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
Primary Outcome
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
Interventions
- DRUG Placebo
- DRUG Efavaleukin Alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 1 |
What the finished NCT03451422 record still lists
NCT03451422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03451422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03451422 about?
NCT03451422 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus". To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
What is the current status of trial NCT03451422?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2018-04-10. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT03451422?
The interventions under investigation include: Placebo (DRUG), Efavaleukin Alfa (DRUG).
Who is sponsoring clinical trial NCT03451422?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03451422's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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