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NCT03410056 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03410056: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT03410056 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03410056, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA). Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with moderate to severe RA.
Primary Outcome
TEAEs were events with an onset after the administration of the first dose of study treatment. TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE). Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL. Grade 4
Interventions
- DRUG Placebo
- DRUG Efavaleukin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-05-22 |
| Est. Completion | 2020-05-13 |
| Phase | Phase 1 |
Why NCT03410056 stopped before completion
NCT03410056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03410056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03410056 about?
NCT03410056 is a clinical study titled "Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis". Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA). Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improve...
What is the current status of trial NCT03410056?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2018-05-22. Estimated completion is 2020-05-13.
What interventions are being tested in trial NCT03410056?
The interventions under investigation include: Placebo (DRUG), Efavaleukin alfa (DRUG).
Who is sponsoring clinical trial NCT03410056?
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 NCT03410056's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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