Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

Phase 3 Completed 268 enrolled aTyr Pharma, Inc. Kyorin Pharmaceutical Co.,Ltd · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.

Timeline

Start: 2022-09-15
Primary completion: 2025-06-25
Completion: 2025-07-14

Outcome

Missed primary endpoint

release “EFZO-FIT™ was a Phase 3 study of efzofitimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint” atyrpharma.com ↗

Publications

Forster S, Chong YE, Siefker D, Becker Y, Bao R, Escobedo E, Qing Y, Rauch K, Burman L, Burkart C, Kainz P, Cubitt A, Muders M, Nangle LA. Development and Characterization of a Novel Neuropilin-2 Antibody for Immunohistochemical Staining of Cancer and Sarcoidosis Tissue Samples. Monoclon Antib Immunodiagn Immunother. 2023 Oct;42(5):157-165. doi: 10.1089/mab.2023.0007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efzofitimod	Unknown	3 mg/kg	Intravenous
Subject	Efzofitimod	Unknown	5 mg/kg	Intravenous