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

This article discusses clinical trials investigating the use of OATD-01, an oral inhibitor of chitinase-1 (CHIT1), for treating active pulmonary sarcoidosis. The KITE study is a randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy and safety of a 12-week administration of OATD-01 in patients with this condition. The trials aim to evaluate the drug’s ability to reduce granulomatous inflammation in the lungs and improve pulmonary function and quality of life for patients with active pulmonary sarcoidosis.

Table of Contents

What is OATD-01?

OATD-01 is a new medication being studied for the treatment of active pulmonary sarcoidosis. It is also known by other names such as OAT-889 and GLPG4716[1]. The full chemical name of this drug is 5-(4-((2S,5S)-5-(4-CHLOROBENZYL)-2-METHYLMORPHOLINO)PIPERIDIN-1-YL)-1H-1,2,4-TRIAZOL-3-AMINE[2].

How Does OATD-01 Work?

OATD-01 is an oral inhibitor of chitinase-1 (CHIT1). Chitinase-1 is an enzyme that may play a role in the inflammation and formation of granulomas (small clusters of inflammatory cells) in sarcoidosis. By inhibiting this enzyme, OATD-01 aims to reduce the inflammation in the lungs of patients with active pulmonary sarcoidosis[1].

Clinical Trial Overview

OATD-01 is currently being studied in a clinical trial called the KITE study. This is a Phase 2 study designed to assess the efficacy and safety of OATD-01 in patients with active pulmonary sarcoidosis. The study is randomized, double-blind, and placebo-controlled, which means that participants will be randomly assigned to receive either OATD-01 or a placebo, and neither the participants nor the researchers will know who is receiving which treatment[1].

The main goal of this study is to evaluate how well OATD-01 reduces granulomatous inflammation in the lungs after 12 weeks of treatment. This will be measured using a special imaging technique called [18F]FDG PET/CT, which can show areas of inflammation in the body[1].

Potential Benefits of OATD-01

The researchers are studying several potential benefits of OATD-01 for patients with active pulmonary sarcoidosis:

  • Reduction of inflammation in the lungs and other parts of the body[1]
  • Improvement in lung function[1]
  • Better quality of life for patients[1]
  • Reduction in fatigue, which is a common symptom of sarcoidosis[1]

Safety Considerations

As with any new medication, the safety of OATD-01 is being carefully studied. The researchers will be monitoring for any side effects or adverse events during the trial. They will also be checking:

  • Heart safety, including any changes in heart rhythm[1]
  • Liver and kidney function[1]
  • Thyroid function[1]
  • Any changes in sperm parameters or testosterone levels in male participants[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key points include:

  • Age 18 or older[1]
  • Diagnosed with active and currently symptomatic pulmonary sarcoidosis[1]
  • Evidence of lung involvement on imaging tests[1]
  • Not currently taking other treatments for sarcoidosis[1]

There are also several factors that would exclude someone from participating, such as certain other medical conditions or medications. If you’re interested in this study, a doctor can help determine if you’re eligible[1].

Conclusion

OATD-01 represents a promising new approach to treating active pulmonary sarcoidosis. By targeting the enzyme chitinase-1, it aims to reduce inflammation and improve symptoms for patients with this condition. While the results of this clinical trial are not yet known, the study will provide valuable information about the effectiveness and safety of OATD-01. As with any experimental treatment, it’s important to discuss the potential risks and benefits with a healthcare provider.

Aspect Details
Study Name KITE study
Drug OATD-01 (5-(4-((2S,5S)-5-(4-CHLOROBENZYL)-2-METHYLMORPHOLINO)PIPERIDIN-1-YL)-1H-1,2,4-TRIAZOL-3-AMINE)
Condition Active Pulmonary Sarcoidosis
Study Type Randomized, double-blind, placebo-controlled, multicenter
Duration 12 weeks
Primary Objective Evaluate response as reduction of granulomatous inflammation in pulmonary parenchyma
Key Measurements Granulomatous inflammation ([18F]FDG PET/CT), Pulmonary function (FVC, FEV1), Quality of life, Safety parameters
Eligibility Adults (≥18 years) with active pulmonary sarcoidosis, evidence of parenchymal pulmonary involvement
Max Daily Dose 25 mg
Administration Route Oral

FAQ

  • What is OATD-01 and how does it work? OATD-01 is an oral inhibitor of chitinase-1 (CHIT1). It is being studied as a potential treatment for active pulmonary sarcoidosis. The drug works by targeting the CHIT1 enzyme, which is believed to play a role in the inflammatory process associated with sarcoidosis.
  • What is the main objective of the KITE study? The main objective of the KITE study is to evaluate the response to a 12-week treatment with OATD-01 in reducing granulomatous inflammation in the lungs of patients with active pulmonary sarcoidosis. This is assessed using [18F]FDG PET/CT imaging.
  • Who is eligible to participate in the clinical trials? Eligible participants are male or female adults (18 years or older) with a diagnosis of active and currently symptomatic pulmonary sarcoidosis. They must have evidence of parenchymal pulmonary involvement on [18F]FDG PET/CT imaging and meet other specific inclusion criteria while not falling under any exclusion criteria.
  • What are some of the key measurements being taken during the trial? Key measurements include changes in granulomatous inflammation using [18F]FDG PET/CT imaging, pulmonary function tests (such as FVC and FEV1), quality of life assessments using questionnaires, and various safety parameters including adverse events, laboratory tests, and cardiac assessments.
  • How long does the treatment last in the clinical trial? The treatment in the clinical trial lasts for 12 weeks. Participants receive either OATD-01 or a placebo during this period, and various assessments are made before, during, and after the treatment to evaluate its efficacy and safety.

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

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

    Recruiting

    2 1
    Investigated drugs:
    Denmark France Germany Greece The Netherlands Norway

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

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Norway Poland

Glossary

  • Active Pulmonary Sarcoidosis: A condition characterized by inflammation in the lungs, causing the formation of granulomas (small clumps of inflammatory cells). It is considered 'active' when symptoms are present and the disease is progressing.
  • Chitinase-1 (CHIT1): An enzyme that may play a role in the inflammatory process associated with sarcoidosis. OATD-01 is designed to inhibit this enzyme.
  • [18F]FDG PET/CT: A medical imaging technique that combines positron emission tomography (PET) with computed tomography (CT). It uses a radioactive tracer (FDG) to visualize and measure metabolic activity in the body, which can indicate areas of inflammation or disease.
  • Granulomatous inflammation: A type of inflammation characterized by the formation of granulomas, which are small clusters of inflammatory cells. In sarcoidosis, these granulomas can form in various organs, particularly the lungs.
  • FVC (Forced Vital Capacity): The total amount of air exhaled during a forced breath. It is a measure of lung function often used in pulmonary function tests.
  • FEV1 (Forced Expiratory Volume in 1 second): The amount of air that can be forcefully exhaled from the lungs in the first second of a forced breath. It is another important measure of lung function.
  • QTcF interval: A measurement on an electrocardiogram (ECG) that represents the time it takes for the heart's electrical system to fire an impulse through the ventricles and then recharge. It is used to assess the risk of certain cardiac arrhythmias.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs. In clinical trials, some participants receive the placebo while others receive the actual drug being studied.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers directly involved know who is receiving the experimental treatment and who is receiving a placebo or standard treatment.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-oatd-01-for-patients-with-active-pulmonary-sarcoidosis/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-oatd-01-for-patients-with-active-pulmonary-sarcoidosis-2/