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NCT03824392 · ClinicalTrials.gov registry record · Phase 1
Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
A Phase 1 study, sponsored by aTyr Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT03824392: Completed Phase 1 study, sponsored by aTyr Pharma.
NCT03824392 is a Phase 1 study that has completed, run by aTyr Pharma. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03824392, a Phase 1 study, has completed, sponsored by aTyr Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis undergoing a protocol-guided oral corticosteroid (OCS) tapering regimen.This study will consist of 3 staggered multiple dose cohorts. Each eligible participant will participate in only one cohort during the study. Within each cohort, 12 participants will be randomized 2:1 to efzofitimod (N=8) or placebo matched to efzofitimod (N=4).
Primary Outcome
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAEs were defined as any adverse event or worsening of an existing condition after initiation of the investigational product and through 30 days after the participant's last study visit (study completion or early termination). SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or signi
Interventions
- BIOLOGICAL Efzofitimod 1.0 mg/kg or Placebo
- BIOLOGICAL Efzofitimod 3.0 mg/kg or Placebo
- BIOLOGICAL Efzofitimod 5.0 mg/kg or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2021-06-29 |
| Phase | Phase 1 |
What the finished NCT03824392 record still lists
NCT03824392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Efzofitimod 1.0 mg/kg or Placebo is the first listed.
NCT03824392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03824392 about?
NCT03824392 is a clinical study titled "Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis". This randomized, double-blind, placebo matched to efzofitimod-controlled, study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK), and preliminary efficacy of multiple ascending doses of IV efzofitimod in participants with pulmonary sarcoidosis undergoing a protocol-guided...
What is the current status of trial NCT03824392?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2019-01-29. Estimated completion is 2021-06-29.
What interventions are being tested in trial NCT03824392?
The interventions under investigation include: Efzofitimod 1.0 mg/kg or Placebo (BIOLOGICAL), Efzofitimod 3.0 mg/kg or Placebo (BIOLOGICAL), Efzofitimod 5.0 mg/kg or Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT03824392?
This trial is sponsored by aTyr Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03824392's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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