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NCT05430854 · ClinicalTrials.gov registry record · Phase 2
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
NCT05430854: Clinical Trial Phase 2 study, sponsored by Amgen.
NCT05430854 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05430854, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
Study Summary
A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose da
Interventions
- BIOLOGICAL Daxdilimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2023-10-31 |
| Phase | Phase 2 |
Why NCT05430854 stopped before completion
NCT05430854 is an interventional study that assigns participants to a tested intervention. The registered 155 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 (17% higher).
The record links to 0 conditions, and to 1 intervention - of which Daxdilimab is the first listed.
NCT05430854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05430854 about?
NCT05430854 is a clinical study titled "Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study". A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.
What is the current status of trial NCT05430854?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2022-06-01. Estimated completion is 2023-10-31.
What interventions are being tested in trial NCT05430854?
The interventions under investigation include: Daxdilimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05430854?
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 NCT05430854's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 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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