aTyr EFZO-FIT Pulmonary Sarcoidosis Study

Are you living with pulmonary sarcoidosis and want to reduce your steroid use?

If so, the aTyr EFZO-FIT™ Pulmonary Sarcoidosis Study may be right for you!

This new clinical research study is now enrolling participants to see if a new study drug can reduce the dose of steroids in people with pulmonary sarcoidosis.

This is an exciting opportunity to join in this clinical trial investigating a potential new drug for pulmonary sarcoidosis. For US and International Audiences.

Purpose

aTyr Pharma has partnered with the Foundation for Sarcoidosis Research for the EFZO-FIT™ study. This exciting clinical trial will see how effective and safe the potential new drug, efzofitimod, is in people with pulmonary sarcoidosis. Researchers want to know whether the drug can reduce the dose of steroids in people with pulmonary sarcoidosis. The study will also see if efzofitimod will maintain symptom control and lung function when steroids are reduced.

Study Design

Eligible participants will receive the study drug or a placebo intravenously (through a small needle into a vein in the arm) every 4 weeks. A total of 12 doses will be given. The study involves a total of 15 visits over a course of 56 weeks. A placebo looks like the study drug but does not contain active medication.

Study Design Timeline

Eligible participants will be asked to gradually reduce their current steroid treatment, beginning 2 weeks after their first dose of the study drug. Steroid treatment can be restarted if it is needed in symptom control.

Participants will attend regular monthly visits at the study centers and have telephone calls between monthly visits. Participants will undergo physical exams, lung function tests and blood tests during these visits.

Who can participate in this trial?

Potential participants should meet the following criteria:

Be between 18-75 years old
Have had pulmonary sarcoidosis for at least 6 months, and currently have symptoms
Have a body weight between 40 kg (88 lbs) and 160 kg (352 lbs)
Have been receiving steroid tablets for at least 3 months (with the same dose of steroid of between 7.5 mg-25 mg per day, for four weeks before coming into the study)
Are willing and able to attempt to gradually stop taking oral corticosteroids during the study

Are willing to commit to attending required study visits and tests for the duration of the study (approximately 1 year)

There are additional criteria that the participant must meet, but that will be discussed with the patient.