Study of Intravenous ATYR1923 (Efzofitimod) for Pulmonary Sarcoidosis
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).
Timeline
- Start
- 2019-01-29
- Primary completion
- 2021-06-29
- Completion
- 2021-06-29
Outcome
Met primary endpoint
release “provide an early indication for ATYR1923 meeting our expectations for the primary endpoint of safety and tolerability” atyrpharma.com ↗
release “Trial met primary endpoint, ATYR1923 was safe and well-tolerated.” atyrpharma.com ↗
Publications
- Walker G, Adams R, Guy L, Chandrasekaran A, Kinnersley N, Ramesh P, Zhang L, Brown F, Niranjan V. Exposure-response analyses of efzofitimod in patients with pulmonary sarcoidosis. Front Pharmacol. 2023 Oct 3;14:1258236. doi: 10.3389/fphar.2023.1258236. eCollection 2023.
- Culver DA, Aryal S, Barney J, Hsia CCW, James WE, Maier LA, Marts LT, Obi ON, Sporn PHS, Sweiss NJ, Shukla S, Kinnersley N, Walker G, Baughman R. Efzofitimod for the Treatment of Pulmonary Sarcoidosis. Chest. 2023 Apr;163(4):881-890. doi: 10.1016/j.chest.2022.10.037. Epub 2022 Nov 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efzofitimod | Unknown | 1 mg/kg | Intravenous |
| Subject | Efzofitimod | Unknown | 3 mg/kg | Intravenous |
| Subject | Efzofitimod | Unknown | 5 mg/kg | Intravenous |