ATYR1923-C-004 (Pulmonary Sarcoidosis) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called efzofitimod (the study drug) is a safe and effective treatment for pulmonary sarcoidosis. We want to know if the study drug can help reduce the dose of steroids people need to take to improve their disease and improve overall lung function.

What is the Condition Being Studied?

Pulmonary Sarcoidosis

Who Can Participate in the Study?

Adults ages 18+ who:

- Are diagnosed with sarcoidosis

- Have been using an oral steroid (e.g., prednisone) for at least 3 months

For more information about who can join this study, contact the study team at shannon.tilley@duke.edu.

What is Involved?

The study includes a screening period which lasts up to 6 weeks. You may have 1 or 2 clinic visits during this period to see if you are eligible for the study.

If you are eligible, you will proceed to the study drug period. During this period, you will:

- Get a random assignment (like a coin flip) to 1 of 2 groups

-- One group will get the study drug once per month

-- The other group will get a placebo (inactive substance with no drug in it) once per month

The study drug period lasts for 48 weeks. You will get the study drug or placebo as an infusion into a vein (IV) in your arm. You will receive a dose of the study drug/placebo once per month during a visit that lasts about 4 hours. We will call you between visits to see how you are check in with you and see how you are doing.

You can read more about this study on its website: https://efzofit.com/

Study Details

Full Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INTRAVENOUS EFZOFITIMOD IN PATIENTS WITH PULMONARY SARCOIDOSIS
Principal Investigator
Pulmonologist
Protocol Number
IRB: PRO00111252
NCT: NCT05415137
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment