NCT03824392

Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis

A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients With Pulmonary Sarcoidosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: aTyr Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
BIOLOGICAL	Efzofitimod 1.0 mg/kg or Placebo	Participants to receive efzofitimod 1.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks
BIOLOGICAL	Efzofitimod 3.0 mg/kg or Placebo	Participants to receive efzofitimod 3.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks
BIOLOGICAL	Efzofitimod 5.0 mg/kg or Placebo	Participants to receive efzofitimod 5.0 mg/kg IV every 4 weeks or placebo matched to efzofitimod every 4 weeks

Timeline

• Start date: 2019-01-29
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2019-01-31
• Last updated: 2023-07-18
• Results posted: 2023-07-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study