Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis

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What is this study about?

This clinical trial is focused on studying active pulmonary sarcoidosis, a condition where clusters of inflammatory cells, known as granulomas, form in the lungs. The study will test a new treatment called OATD-01, which is an oral medication designed to reduce this inflammation. The medication is taken in the form of film-coated tablets. Participants in the study will either receive OATD-01 or a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate how well OATD-01 works in reducing lung inflammation over a 12-week period. Participants will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. Throughout the study, participants will undergo various assessments, including imaging tests, to monitor changes in lung inflammation and overall health.

The study aims to gather information on the effectiveness and safety of OATD-01 for treating active pulmonary sarcoidosis. Participants will be closely monitored for any changes in their condition and any side effects they may experience. The study will help determine if OATD-01 can be a beneficial treatment option for people with this condition.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be required to provide written informed consent before any study procedures begin.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history, a physical examination, and imaging tests such as [18F]FDG PET/CT to evaluate lung involvement.

3 randomization

You will be randomly assigned to receive either the study medication OATD-01 or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

4 treatment phase

During the 12-week treatment phase, you will take the assigned medication orally in the form of film-coated tablets. The dosage and frequency will be provided by the study team. Regular follow-up visits will be scheduled to monitor your health and response to the treatment.

5 monitoring and assessments

Throughout the study, you will undergo various assessments, including imaging tests, lung function tests, and questionnaires to evaluate your quality of life. Blood tests and other evaluations will be conducted to monitor for any side effects or changes in your health.

6 end of treatment evaluation

At the end of the 12-week treatment period, a final evaluation will be conducted to assess your response to the treatment. This will include imaging tests and other assessments similar to those conducted during the study.

7 follow-up

After completing the treatment phase, you may be asked to attend follow-up visits to monitor your health and any long-term effects of the treatment. The study team will provide specific instructions regarding these visits.

Who Can Join the Study?

Must be a male or female aged 18 years or older.
Must have a diagnosis of active and currently symptomatic pulmonary sarcoidosis. This means the lungs are affected by the disease, and the person is experiencing symptoms. The person can be new to treatment or have been treated before but is not currently receiving treatment.
Must have lung involvement shown by a special imaging test called [18F]FDG PET/CT at the start of the study. This test helps to see inflammation in the lungs.
Must have a Body Mass Index (BMI) between 18 and 46 kg/m². BMI is a measure of body fat based on height and weight.
Must agree to avoid pregnancy or fathering a child during the study. This means using effective birth control methods throughout the study and for a specified time after the study ends. This applies to both men and women participating in the study.
Must be able to understand and follow the study requirements.
Must provide written informed consent before starting any study procedures. This means agreeing to participate in the study after being informed about all aspects of the study.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to the study medication or its ingredients.
Patients who are unable to comply with the study procedures.
Patients with a history of drug or alcohol abuse within the past year.
Patients with unstable or uncontrolled medical conditions.
Patients who have had a major surgery within the last 3 months.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.
Patients with active infections that require treatment.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
University General Hospital Of Heraklion	Heraklion	Greece
Vitamed Galaj I Cichomski Sp. j.	Bydgoszcz	Poland
General Hospital Of Corfu Agia Eirini	Corfu	Greece
Hôpital Avicenne	Bobigny	France
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Amhabeuj Umdhegebze Hfpltgwd	Lorenskog	Norway
Hthfy Bkundb Hu	Bergen	Norway
Acomixw Syhxxkxyczmdmeg Pbllrimu Loeeowew Ppyuz Scjktemyr	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.02.2024
France	Not yet recruiting	01.02.2024
Germany	Not yet recruiting	01.02.2024
Greece	Not yet recruiting	01.02.2024
Norway	Not yet recruiting	01.02.2024
Poland	Not yet recruiting	01.02.2024

Trial locations

Investigated drugs:

5-(4-((2S,5S)-5-(4-Chlorobenzyl)-2-Methylmorpholino)Piperidin-1-Yl)-1H- 1,2,4-Triazol-3-Amine

OATD-01 is a medication being tested in this clinical trial. It is taken by mouth and works by blocking a specific enzyme called chitinase-1 (CHIT1). This enzyme is thought to play a role in causing inflammation in the lungs, which is a problem for people with a condition called pulmonary sarcoidosis. The goal of using OATD-01 in this study is to see if it can help reduce this inflammation in the lungs, making it easier for patients to breathe and improving their overall lung health. The effectiveness of this medication is being measured using a special type of imaging called PET/CT scans, which can show changes in lung inflammation.

Investigated diseases:

Pulmonary sarcoidosis

Active Pulmonary Sarcoidosis – Active Pulmonary Sarcoidosis is a condition characterized by the formation of small clusters of inflammatory cells, known as granulomas, in the lungs. These granulomas can cause the lung tissue to become inflamed and may lead to scarring over time. The disease often begins with symptoms such as a persistent cough, shortness of breath, and chest pain. As the condition progresses, it can affect lung function, leading to reduced ability to breathe deeply or efficiently. The inflammation can also spread to other parts of the body, including the lymph nodes and skin. The progression of the disease varies among individuals, with some experiencing mild symptoms and others facing more severe respiratory issues.

Trial ID:

2023-506642-23-00

Protocol code:

OATD-01-C-03

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis

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