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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.

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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

FieldValue
Enrollment Target 37 participants
Start Date 2019-01-29
Est. Completion 2021-06-29
Phase Phase 1

Sponsor

aTyr Pharma

9 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.