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NCT04680637 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT04680637: Clinical Trial Phase 2 study, sponsored by Amgen.
NCT04680637 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04680637, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
Primary Outcome
A participant achieved an SRI-4 response if all the following criteria were met: * ≥ 4-point reduction from baseline in Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score (scale 0-105, with higher scores indicating more disease activity). * No new British-Isles Lupus Assessment Group (BILAG) A score and no \> 1 new BILAG B organ domain scores compared with baseline. The BILAG index evaluates disease activity in 9 separate organ systems. Each of the organ systems are allo
Interventions
- DRUG Placebo
- OTHER Standard of Care
- DRUG Efavaleukin Alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 2 |
Why NCT04680637 stopped before completion
NCT04680637 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04680637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04680637 about?
NCT04680637 is a clinical study titled "Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus". The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.
What is the current status of trial NCT04680637?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2021-05-06. Estimated completion is 2023-05-22.
What interventions are being tested in trial NCT04680637?
The interventions under investigation include: Placebo (DRUG), Standard of Care (OTHER), Efavaleukin Alfa (DRUG).
Who is sponsoring clinical trial NCT04680637?
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 NCT04680637's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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