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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

10 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

OATD-01 – OATD-01 is an oral medication currently being studied for its potential to treat active pulmonary sarcoidosis, a condition characterized by inflammation in the lungs. This medication is taken by mouth and works by inhibiting an enzyme called chitinase-1 (CHIT1), which is believed to play a role in the inflammatory process. The main goal of the ongoing clinical trial is to determine if OATD-01 can reduce lung inflammation over a 12-week period, as observed through specialized imaging techniques. OATD-01 is classified as an enzyme inhibitor, and its development is still in the research phase, with its effectiveness and safety being evaluated in clinical studies.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506642-23-00Protocol codeOATD-01-C-03Estimated enrolment112 patientsSponsorMolecure S.A.

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