Clinical Trials for Pulmonary Sarcoidosis
There are currently 6 ongoing clinical trials investigating new treatments for pulmonary sarcoidosis. These studies are testing various medications including OATD-01, hydroxychloroquine, methotrexate, efzofitimod, and namilumab across multiple countries in Europe. The trials aim to improve lung function, reduce inflammation, and decrease the need for corticosteroids in patients living with this condition.
Clinical trial locations
- Belgium
- Denmark
- Espagne
- France
- Study of hydroxychloroquine with low-dose corticosteroids compared to medium-dose corticosteroids in patients with pulmonary sarcoidosis
- Study on Efzofitimod for Treating Pulmonary Sarcoidosis in Patients
- Study on the Effects and Safety of Namilumab for Patients with Chronic Lung Sarcoidosis
- Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis
- Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis
- Germany
- Greece
- Italy
- Netherlands
- Study on Efzofitimod for Treating Pulmonary Sarcoidosis in Patients
- Study on Methotrexate and Prednisone for Treating Lung Sarcoidosis in Patients
- Study on the Effects and Safety of Namilumab for Patients with Chronic Lung Sarcoidosis
- Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis
- Norway
- Poland
- Spain
- United Kingdom
Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis
This trial is evaluating OATD-01, a new oral medication designed to reduce lung inflammation in people with active disease. The medication works by blocking an enzyme called chitinase-1, which is believed to contribute to inflammation in the lungs.
Main inclusion criteria: Participants must be at least 18 years old and have a confirmed diagnosis of active and symptomatic disease affecting the lungs. This includes both treatment-naïve patients and those who have been treated before but are not currently receiving treatment. Evidence of lung involvement must be shown through imaging tests such as chest X-ray, CT scan, or a special PET/CT scan. Participants must have a Body Mass Index between 18 and 46 kg/m² and agree to use effective birth control methods during the study.
Main exclusion criteria: Patients without active disease, those outside the specified age range, or those unable to undergo required imaging tests cannot participate. The study also excludes vulnerable populations that require special protections.
Focus and goal: The trial lasts 12 weeks and uses a double-blind design, meaning neither participants nor researchers know who receives the actual medication versus a placebo. Regular assessments include imaging tests, lung function measurements, and quality of life questionnaires to evaluate whether OATD-01 can reduce inflammation, improve breathing, and enhance overall well-being.
Investigational drug: OATD-01 is taken as film-coated tablets and represents a novel approach to treating inflammation by targeting a specific enzyme involved in the disease process.
Study of hydroxychloroquine with low-dose corticosteroids compared to medium-dose corticosteroids in patients with pulmonary sarcoidosis
This French trial compares two treatment approaches: combining hydroxychloroquine with low-dose prednisone versus using medium-dose prednisone alone. The goal is to determine if the combination treatment works as well as standard therapy while potentially reducing steroid-related side effects.
Main inclusion criteria: Adults aged 18 to 80 years with confirmed diagnosis according to ATS 2020 criteria can participate. Participants must have visible lung involvement on imaging, reduced lung capacity (FVC ≤80% of normal) or significant recent decline, and at least one respiratory symptom such as cough, shortness of breath, or chest pain. Women of childbearing potential must use effective birth control during the study and for 8 months afterward.
Main exclusion criteria: The study excludes those with allergic reactions to the study medications, pregnant or breastfeeding women, people with severe kidney or liver disease, active infections, heart rhythm problems, eye conditions like retinopathy, uncontrolled diabetes, advanced lung disease requiring oxygen, or recent cancer history.
Focus and goal: The study runs for 24 months, with the primary assessment at 6 months. Researchers monitor lung function improvements, quality of life, and medication side effects. Regular evaluations include breathing tests, six-minute walk tests, and blood tests to measure disease activity.
Investigational drugs: Hydroxychloroquine, commonly used for malaria and autoimmune conditions, is being tested in combination with low-dose corticosteroids. Corticosteroids are standard anti-inflammatory medications that help reduce lung inflammation.
Study on Methotrexate and Prednisone for Treating Lung Sarcoidosis in Patients
This Netherlands-based study directly compares methotrexate and prednisone as first-line treatment options. The trial aims to determine which medication is more effective for initial therapy.
Main inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis according to ATS 2020 criteria or expert team assessment. Eligibility requires evidence of lung involvement on recent imaging and specific lung function test results: forced vital capacity of 90% or less of expected, or diffusion capacity of 70% or less of expected, or a recent significant decline in these measurements.
Main exclusion criteria: The trial excludes patients without confirmed diagnosis, those outside the age requirement, people unable to perform required breathing tests, or those with severe kidney or liver disease that would contraindicate the medications.
Focus and goal: The 24-week study monitors changes in lung capacity, particularly forced vital capacity, along with various biomarkers. Both medications are taken orally in tablet form. Regular assessments track lung function and overall health to evaluate effectiveness and tolerability.
Investigational drugs: Methotrexate works by interfering with cell growth and reducing inflammation, while prednisone is a corticosteroid that mimics natural hormones to reduce inflammation and suppress the immune system.
Study on the Effects of OATD-01 for Patients with Active Pulmonary Sarcoidosis
This multinational trial across Poland, France, Denmark, Greece, Norway, and Germany tests the same OATD-01 medication as the first study but in different geographic locations, expanding access to this investigational treatment.
Main inclusion criteria: Adults 18 years or older with active and symptomatic disease can participate. Diagnosis must be confirmed with lung involvement visible on PET/CT imaging at screening. Body Mass Index must be between 18 and 46 kg/m². Both treatment-naïve patients and those previously treated but not currently receiving treatment are eligible. Effective birth control is required throughout the study.
Main exclusion criteria: Those with other serious health conditions that could interfere with the study, pregnant or breastfeeding women, recent participants in other clinical trials, people with known allergies to the study medication, those unable to comply with study procedures, recent substance abuse history, unstable medical conditions, recent major surgery, or active infections requiring treatment are excluded.
Focus and goal: The 12-week double-blind trial evaluates OATD-01’s ability to reduce lung inflammation using specialized imaging. Regular monitoring includes physical examinations, lung function tests, and quality of life assessments. The study includes follow-up visits after treatment to monitor long-term effects.
Investigational drug: OATD-01 is administered orally as film-coated tablets and works by inhibiting chitinase-1, an enzyme involved in inflammatory processes in the lungs.
Study on Efzofitimod for Treating Pulmonary Sarcoidosis in Patients
This study across France, Spain, Italy, Netherlands, and Germany evaluates efzofitimod, an intravenous medication that targets immune system pathways to reduce inflammation.
Main inclusion criteria: Men and women aged 18 to 75 years with confirmed diagnosis for at least 6 months can participate. Participants must have symptoms demonstrated by breathlessness scores and lung health assessments. They must be taking oral corticosteroids for at least 3 months at doses between 7.5 mg and 25 mg daily. Body weight must be between 40 kg and 160 kg. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control through 8 weeks after the last dose.
Main exclusion criteria: The study excludes those outside the specified age range, patients from vulnerable populations requiring special protection, and those who do not meet the specific disease activity and medication requirements.
Focus and goal: The trial runs up to 48 weeks and compares efzofitimod to placebo. Regular monitoring includes lung function tests, physical examinations, and assessments of symptoms and quality of life. The study evaluates whether efzofitimod can help manage symptoms and reduce the need for corticosteroids.
Investigational drug: Efzofitimod is delivered through intravenous infusion directly into the bloodstream. It is classified as an immunomodulatory agent that helps regulate immune system activity to reduce inflammation.
Study on the Effects and Safety of Namilumab for Patients with Chronic Lung Sarcoidosis
This trial in Belgium, France, Germany, and Netherlands tests namilumab, a monoclonal antibody designed to reduce inflammation by targeting specific immune system proteins.
Main inclusion criteria: Adults 18 years or older with documented history of the disease for at least 6 months can participate. Eligibility requires specific findings on HRCT scans, breathing difficulty scores of 2 or more, and evidence of active disease through PET scans or recent symptom worsening. Body Mass Index must be 40 kg/m² or less. Participants must have completed primary COVID-19 vaccinations at least 2 weeks before starting the study.
Main exclusion criteria: Those with other serious health conditions that could interfere with the study, patients taking medications that might affect results, recent surgery or medical procedures, pregnant or breastfeeding women, history of allergic reactions to similar treatments, inability to follow study procedures, recent participation in other trials, substance abuse history, active infections, or mental health conditions affecting participation are excluded.
Focus and goal: The study evaluates whether namilumab can reduce the need for additional treatments when the disease worsens. The trial includes a double-blind phase followed by an open-label extension where all participants receive the active medication. Regular assessments monitor lung function, quality of life, and safety through physical examinations, vital signs, electrocardiograms, and laboratory tests.
Investigational drug: Namilumab is administered as a subcutaneous injection under the skin. As a monoclonal antibody, it specifically targets molecules involved in the inflammatory process to help reduce lung inflammation.
Summary
The six ongoing clinical trials for pulmonary sarcoidosis represent diverse therapeutic approaches across Europe. France appears most active in clinical research with participation in five trials, followed by Germany and Netherlands with four trials each. This geographic concentration suggests strong research infrastructure and medical expertise in these countries.
The trials test several treatment strategies: novel enzyme inhibitors like OATD-01, traditional medications like methotrexate and hydroxychloroquine in new combinations, and advanced biologics including efzofitimod and namilumab. Most studies focus on reducing inflammation, improving lung function, and decreasing dependence on corticosteroids, which can cause significant side effects with long-term use.
Treatment durations vary from 12 weeks to 24 months, with some including open-label extensions for continued monitoring. The studies employ rigorous double-blind designs to ensure reliable results. All trials emphasize safety monitoring alongside effectiveness evaluation, providing comprehensive data on new treatment options for this challenging condition.
