Purpose

This Phase 2 study, also known as a clinical trial, aims to find out if OATD-01 is safe and effective for patients with active pulmonary sarcoidosis. Researchers want to know if this medicine is safe, and if it may help reduce granulomatous inflammation caused by sarcoidosis in the lungs.

 

What is this medicine?

OATD-01 is taken by mouth. It is a first-in-class chitotriosidase 1 (CHIT1) inhibitor, which has the potential to modify the course of disease in sarcoidosis by controlling inflammation effects in the body.

 

What should I know about this study?

This study will test an experimental medicine for the first time in patients with pulmonary sarcoidosis.

Individuals who enroll will be randomly assigned to receive either the experimental medicine or a placebo. A placebo looks like the experimental medicine, but it won’t have any effect on the person who gets it.

You can withdraw from the study at any time and for any reason without any effect on your legal rights or the standard of care you receive.

 

What will I do in this study?

There will be a screening period for up to 6 weeks, a treatment period for 12 weeks, and then a follow up visit approximately 4 weeks post last dose.  The study will last up to 22 weeks in total.

You will complete 6-7 on-site visits and 3-4 tele-health visits with the study team. Each person is expected to complete the study, attending all scheduled onsite and follow-up visits.

Your expenses for travel and meals will be reimbursed.

 

Am I eligible for this study?

You may be eligible to participate if:

• • You are more than 18 years old
  • You have sarcoidosis in your lungs
  • You experience some symptoms, but you are not currently under treatment
  • Your doctor considers that you may soon but not immediately require treatment (e.g. corticosteroids)

 

How do I apply?

Click the buttons below to learn more. You can select your location on the study website and complete the pre-screening questions. The study team will contact you and let you know if you are eligible.

If you are located near Cleveland, OH, please click here to contact the closest study team.