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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 is a Phase 1 study that has completed, run by aTyr Pharma. The registered enrollment target is 37 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03824392
The ClinicalTrials.gov registry entry for NCT03824392 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is aTyr Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Efzofitimod 1.0 mg/kg or Placebo is the first listed.
NCT03824392 reports 0 study locations.
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.
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