Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Pulmonary Sarcoidosis
In brief
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).
Key facts
- Study ID
- NCT03824392
- Run by
- aTyr Pharma, Inc.
- People needed
- 37
- Starts
- 2019-01-29
- Expected to finish
- 2021-06-29
- Last updated by the study team
- 2023-07-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- aTyr Investigative Site — Northridge, California, United States
- National Jewish Health — Denver, Colorado, United States
- aTyr Investigative Site — Miami, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- aTyr Investigative Site — Chicago, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Louisville — Louisville, Kentucky, United States
- East Carolina University — Greenville, North Carolina, United States
- University of Cincinnati — Cincinnati, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Inova Fairfax Medical Center — Falls Church, Virginia, United States
Full record on ClinicalTrials.gov
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