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NCT03422627 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03422627: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT03422627 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03422627, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria. Due to early termination, the Phase 2 portion of this study was not conducted.
Primary Outcome
A DLT was defined as a: * Non-hematological toxicity ≥grade-4(per common terminology criteria for adverse events \[CTCAE\] v4.03) related to efavaleukin alfa. Non-hematological lab abnormalities without clinical significance weren't considered DLTs. * Hematological toxicity ≥grade 4 related to efavaleukin alfa defined as decreases in peripheral counts (absolute neutrophil count or platelets) persisting longer than 72 hrs, as measured by 2 separate results, that were not related to malignant dis
Interventions
- DRUG Efavaleukin Alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2022-10-13 |
| Phase | Phase 1 |
Why NCT03422627 stopped before completion
NCT03422627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Efavaleukin Alfa is the first listed.
NCT03422627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03422627 about?
NCT03422627 is a clinical study titled "Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease". Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall res...
What is the current status of trial NCT03422627?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-04-27. Estimated completion is 2022-10-13.
What interventions are being tested in trial NCT03422627?
The interventions under investigation include: Efavaleukin Alfa (DRUG).
Who is sponsoring clinical trial NCT03422627?
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 NCT03422627's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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