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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 the treatment of active pulmonary sarcoidosis, a condition where clusters of inflammatory cells, known as granulomas, form in the lungs. The study will evaluate the effects of a new medication called OATD-01, which is taken as a tablet. OATD-01 is designed to inhibit a specific enzyme called chitinase-1 (CHIT1), which is believed to play a role in the inflammation process associated with sarcoidosis.

The purpose of the study is to assess the effectiveness and safety of OATD-01 over a 12-week period. Participants will be randomly assigned to receive either OATD-01 or a placebo, and neither the participants nor the researchers will know which treatment is being administered. Throughout the study, participants will undergo various assessments, including imaging tests like [18F]FDG PET/CT, to monitor changes in lung inflammation and overall health. The study aims to determine if OATD-01 can reduce the inflammation in the lungs and improve lung function and quality of life for those with active pulmonary sarcoidosis.

Participants will be closely monitored for any side effects or changes in their health during the study. The trial will also collect data on various health parameters, such as lung function tests and quality of life questionnaires, to evaluate the overall impact of the treatment. The study is expected to provide valuable insights into the potential benefits of OATD-01 for individuals with active pulmonary sarcoidosis.

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, the participant will be informed about the trial's purpose and procedures. Written consent is required before any study activities begin.

  2. Step 2

    Screening

    The screening process involves confirming the diagnosis of active pulmonary sarcoidosis through imaging tests such as [18F]FDG PET/CT. Eligibility criteria include age, body mass index, and agreement to use effective birth control methods.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either the study medication OATD-01 or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  4. Step 4

    Treatment phase

    The treatment phase lasts for 12 weeks. Participants take the assigned medication orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants undergo regular assessments to monitor their health and the effects of the treatment. This includes imaging tests, lung function tests, and questionnaires about quality of life and fatigue.

  6. Step 6

    End of treatment

    At the end of the 12-week treatment period, participants undergo final assessments to evaluate the response to the treatment. This includes imaging tests and other health evaluations.

  7. Step 7

    Follow-up

    Participants are monitored for any long-term effects or changes in their condition after the treatment phase has ended. This includes additional health assessments and questionnaires.

Who can join the trial?

8 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 showing symptoms. The person can be either new to treatment or has been treated before but is not currently receiving treatment.
  • Must have certain findings on chest X-ray or CT scan, such as **Bilateral hilar adenopathy (BHA)**, which means swelling of lymph nodes in the chest, or other specific patterns seen in the lungs.
  • Must have evidence of lung involvement shown by a special imaging test called **[18F]FDG PET/CT** at the time of screening or within 3 months before joining the study.
  • 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 and use effective birth control methods. This includes women who are not able to have children or those who can have children but agree to use highly effective contraception. Men must agree to use double barrier contraception or be surgically sterilized.
  • 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 after understanding the study details.

Who cannot join the trial?

4 criteria

  • Patients who do not have active pulmonary sarcoidosis cannot participate. This means the study is only for those currently experiencing this condition.
  • Patients who are not within the specified age range cannot participate. The study has specific age requirements.
  • Patients who are not able to undergo certain imaging tests, like [18F]FDG PET/CT, cannot participate. This is a special type of scan used to look at the lungs.
  • Patients who are part of a vulnerable population that the study does not include cannot participate. This means the study is careful about who it includes to ensure safety.
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Investigated drugs

OATD-01 is an oral medication being studied for its potential to treat active pulmonary sarcoidosis. It works by inhibiting an enzyme called chitinase-1 (CHIT1), which is thought to play a role in the inflammation associated with this condition. The goal of the study is to see if taking OATD-01 for 12 weeks can reduce the inflammation in the lungs of patients with sarcoidosis, as measured by a special type of imaging called [18F]FDG PET/CT.

What is already known about the treatment

OATD-01 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating active pulmonary sarcoidosis. It is an experimental drug, and its status in medical literature is primarily within the research phase. The main therapeutic indication for OATD-01 is to reduce inflammation in the lungs caused by sarcoidosis. At the molecular level, it works by inhibiting chitinase-1 (CHIT1), an enzyme involved in the inflammatory process. OATD-01 is classified pharmacologically as an enzyme inhibitor.

Investigated diseases

Active Pulmonary Sarcoidosis – This is a condition characterized by the growth of tiny collections 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 can cause symptoms such as a persistent cough, shortness of breath, and chest pain. It may also affect other organs, but primarily impacts the lungs. The progression of the disease can vary, with some individuals experiencing mild symptoms that improve on their own, while others may have more severe and persistent symptoms. The exact cause of sarcoidosis is unknown, but it is believed to involve an abnormal immune response.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506642-23-01Protocol codeOATD-01-C-03Estimated enrolment111 patientsSponsorMolecure S.A.

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