NCT05415137

Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: aTyr Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Sarcoidosis

Interventions

Type	Name	Description
DRUG	Efzofitimod 3 mg/kg	EfzofitimodIV infusion every 4 weeks for a total of 12 doses
DRUG	Efzofitimod 5 mg/kg	EfzofitimodIV infusion every 4 weeks for a total of 12 doses
DRUG	Placebo	Placebo IV infusion every 4 weeks for a total of 12 doses

Timeline

• Start date: 2022-09-15
• Primary completion: 2025-07-31
• Completion: 2025-08-31
• First posted: 2022-06-10
• Last updated: 2025-05-20

Locations

91 sites across 9 countries: United States, Brazil, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study