RecruitingPHASE2INTERVENTIONAL

Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

This study, called a Phase 2 trial, is looking into a new medicine named OATD-01 for people who have active sarcoidosis affecting their lungs. We want to find out how well OATD-01 works, if it's safe, and how the body handles it. Participants will be split into two groups by chance: one group will receive OATD-01, and the other will get a 'dummy' medicine (placebo). This is done without anyone knowing which treatment they are receiving until the study is over. The study aims to get a clearer picture of the potential benefits and any potential side effects of OATD-01 to help future treatment options for pulmonary sarcoidosis.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Molecure S.A.

Enrolment target

Start

21 Mar 2024

Estimated completion

01 Sep 2027

Pulmonary Sarcoidosis

What is this study about?

This study is for adults (aged 18 and over) who have sarcoidosis that is active in their lungs and is causing symptoms. Sarcoidosis is a condition where tiny clumps of inflammatory cells, called granulomas, can form in different organs of the body. When these clumps appear in the lungs, it is known as pulmonary sarcoidosis. We are particularly looking for people with active sarcoidosis, which means it’s currently causing problems, and we confirm this using a special scan called a PET/CT scan.

The main goal of this study is to see if a new medicine, OATD-01, can safely and effectively treat active pulmonary sarcoidosis. We also want to understand how this medicine works in the body. Some people in the study might not have had treatment for sarcoidosis before, while others might have been treated in the past but aren't currently receiving any sarcoidosis medication.

To make sure the study results are fair and accurate, participants will be randomly assigned to one of two groups. One group will receive OATD-01, and the other will receive a placebo – which looks exactly like the study medicine but contains no active drug. Neither you nor your study doctor will know which treatment you are receiving until the study is finished. This helps us objectively compare the new medicine's effects against not receiving it.

Key takeaways

This study is testing a new medicine, OATD-01, for active sarcoidosis in the lungs.
It's a Phase 2 trial, focusing on treatment effectiveness and safety.
You'll either receive OATD-01 or a placebo (dummy medicine).
Neither you nor your doctor will know which treatment you are getting.
Participation involves regular clinic visits for about 12 weeks.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be 18 years or older and have sarcoidosis that is clearly active in your lungs and causing symptoms. Your doctor will confirm this using standard guidelines and a special scan. You can join whether you've been treated for sarcoidosis before or if this is your first time.

However, there are certain situations that would prevent you from taking part. For example, if you need to start standard sarcoidosis treatment right away, or if your sarcoidosis is affecting your heart or brain. You also can't participate if you have certain other serious lung conditions like tuberculosis or severe asthma, or if you have specific heart conditions or certain abnormal blood test results.

If you're currently taking other medications for sarcoidosis, you might not be able to join unless you stopped taking them a certain amount of time ago (e.g., corticosteroids more than 3 months ago, or other strong anti-inflammatory drugs more than 4 months ago). The study team will review all your medical information carefully to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have active sarcoidosis in your lungs that is causing symptoms?
Have you been diagnosed with sarcoidosis using standard medical guidelines?
Are you able to attend regular clinic visits for about 12 weeks?
Do you *not* currently need urgent treatment for your sarcoidosis?
Do you *not* have sarcoidosis affecting your heart or brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for about 12 weeks. During this time, you will visit the study clinic regularly. At these visits, doctors and nurses will check your health, ask about your symptoms, and carry out various tests including blood tests and possibly repeat scans to see how you are responding. You will receive either OATD-01 or a placebo, which you will take as instructed by the study team. Both you and your doctor will not know which one you are receiving. The study team will explain all the visits and tests in detail before you make a decision.

Potential risks and benefits

Taking part in a clinical study means you might benefit from a new treatment before it's widely available. However, there's no guarantee that OATD-01 will help your condition, and like all medicines, it might have side effects that we don't fully know about yet. You will be closely monitored for any reactions or changes in your health. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Molecure Investigative Site
Verified postcode
Birmingham, United States· Withdrawn
Molecure Investigative Site
Verified postcode
Kansas City, United States· Withdrawn
Molecure Investigative Site
Verified postcode
Baltimore, United States· Recruiting
Molecure Investigative Site
Verified postcode
Rochester, United States· Withdrawn
Molecure Investigative Site
Verified postcode
Cleveland, United States· Recruiting
Molecure Investigative Site
Verified postcode
Philadelphia, United States· Recruiting
Molecure Investigative Site
Verified postcode
Charleston, United States· Recruiting
Molecure Investigative Site
Verified postcode
Vejle, Denmark· Withdrawn
Molecure Investigative Site
Verified postcode
Bobigny, France· Withdrawn
Molecure Investigative Site
Verified postcode
Montpellier, France· Recruiting
Molecure Investigative Site
Verified postcode
Paris, France· Recruiting
Molecure Investigative Site
Verified postcode
Paris, France· Recruiting

Common questions

What is pulmonary sarcoidosis?

It's a condition where tiny clumps of cells grow in the lungs, which can cause symptoms like coughing or shortness of breath.

What does 'Phase 2' mean?

Phase 2 studies are an early stage where we test if a new medicine works and is safe in a small group of people with the condition.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps us compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know until the study is over. This is called 'double-blinded' and helps make the results fair.

How long will I be in the study?

The active treatment period for this study is 12 weeks, with regular visits during that time.

How to find out more

Theodoros Charitos, MD

t.charitos@molecure.com +48789125928 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.