Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Public ClinicalTrials.gov record NCT03824392. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients With Pulmonary Sarcoidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03824392
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 37 participants
Conditions and interventions
Conditions
Interventions
- Efzofitimod 1.0 mg/kg or Placebo Biological
- Efzofitimod 3.0 mg/kg or Placebo Biological
- Efzofitimod 5.0 mg/kg or Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2019
- Primary completion
- Jun 28, 2021
- Completion
- Jun 28, 2021
- Last update posted
- Jul 17, 2023
2019 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0006 | — |
| aTyr Investigative Site | Northridge | California | 91324 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| aTyr Investigative Site | Miami | Florida | 33125 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| aTyr Investigative Site | Chicago | Illinois | 60612 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| East Carolina University | Greenville | North Carolina | 27858 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Medical University of South Carolina | Charleston | South Carolina | 92425 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Inova Fairfax Medical Center | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03824392, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2023 · Synced Sep 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03824392 live on ClinicalTrials.gov.