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Clinical Trials for Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis is a serious lung condition where tissue becomes scarred, making breathing increasingly difficult. Currently, 23 clinical trials are testing new treatments to slow disease progression, reduce symptoms like cough, and improve quality of life for patients. These studies are taking place across Europe and involve various types of medications, from tablets to inhaled therapies.

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Long-Term Safety Study of Inhaled Pirfenidone for Patients with Progressive or Idiopathic Pulmonary Fibrosis

This study examines an inhaled form of pirfenidone, a medication currently used in tablet form for treating lung fibrosis. The trial is designed for patients who have already participated in previous trials testing inhaled antifibrotic treatments and will continue to monitor their safety and how well they tolerate the treatment over an extended period.

Who can participate: Eligible participants must have completed previous Avalyn-sponsored trials with inhaled antifibrotic medications for progressive or idiopathic pulmonary fibrosis without stopping the treatment early. Participants must be at least 18 years old and willing to use highly effective birth control methods during the study and for 90 days afterward.

Who cannot participate: The exclusion criteria appear limited since the trial focuses on participants who have already been treated with the medication in previous studies. Patients with a history of progressive pulmonary fibrosis or idiopathic pulmonary fibrosis who have not participated in previous Avalyn trials would not be eligible.

Study focus: The main goal is to evaluate the long-term safety and tolerability of inhaled pirfenidone. Researchers will monitor any treatment-emergent adverse events, serious adverse events, and changes in lung function by measuring forced vital capacity at six-month intervals throughout the study period, which extends until December 2031.

Medication tested: Pirfenidone Solution for Inhalation is delivered through the eFlow Nebulizer System, allowing the medication to be breathed directly into the lungs. This method may offer advantages over oral medication by delivering the drug directly to the affected tissue.

Long-Term Study of BI 1015550 for Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

This trial continues to evaluate BI 1015550, a film-coated tablet, in patients who have previously participated in earlier studies with this medication. The research extends over 99 weeks to gather information about long-term safety and effectiveness.

Who can participate: Patients who have completed treatment in previous trials (1305-0014 or 1305-0023) without stopping early can join. They must provide written consent and agree to use highly effective birth control methods. The study is open to both male and female participants who meet the continuation criteria from the previous trials.

Who cannot participate: Patients who stopped taking the trial medication early in previous studies or who did not complete the planned treatment in earlier related trials are not eligible.

Study focus: The primary objective is to monitor the long-term safety and tolerability of BI 1015550. Researchers will track treatment-emergent adverse events, serious adverse events, and changes in lung function measured by forced vital capacity and diffusing capacity for carbon monoxide. The study will also assess the time to significant health events related to pulmonary fibrosis.

Medication tested: BI 1015550 is an oral anti-fibrotic agent currently in the investigational stage. It targets specific pathways involved in fibrosis, potentially slowing down or halting lung tissue damage progression.

Study of tezepelumab in patients with progressive pulmonary fibrosis and increased eosinophil levels in blood

This research focuses on a specific group of progressive pulmonary fibrosis patients who have elevated levels of eosinophils, a type of white blood cell. The study examines whether tezepelumab, delivered by injection under the skin, can reduce these elevated eosinophil levels.

Who can participate: Eligible participants must be at least 18 years old with a diagnosis of progressive pulmonary fibrosis and elevated eosinophil counts in blood or lung fluid tests within the past year. They must be taking stable doses of anti-scarring medication (nintedanib or pirfenidone) for at least two months. If taking immune-suppressing medications, doses must remain stable for at least three months, and corticosteroid doses must not exceed 10mg daily.

Who cannot participate: Patients outside the age range of 18-75 years, those who are pregnant or breastfeeding, individuals who have previously received tezepelumab, patients with active tuberculosis, recent cancer history within five years, severe liver or kidney disease, uncontrolled high blood pressure, recent heart problems or stroke, active infections requiring treatment, or those with known allergies to similar medications are excluded.

Study focus: The main goal is to determine if tezepelumab can reduce eosinophil levels in the blood after 24 weeks of treatment. Secondary objectives include monitoring lung function through forced vital capacity measurements, quality of life assessments, and the 6-minute walking test. The total follow-up period extends to 56 weeks.

Medication tested: Tezepelumab is a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a protein involved in inflammatory responses. By blocking TSLP signaling, it aims to reduce eosinophil levels and address the inflammatory component of the disease.

Study on Axatilimab for Patients with Idiopathic Pulmonary Fibrosis

This trial evaluates axatilimab, an intravenous medication, compared to placebo to understand its impact on lung function in people with idiopathic pulmonary fibrosis over 26 weeks.

Who can participate: Participants must be 40 years or older with a documented diagnosis of idiopathic pulmonary fibrosis confirmed by high-resolution computed tomography scan. Lung function tests must show forced vital capacity of at least 45% of predicted value, forced expiratory volume to forced vital capacity ratio of at least 0.7, and diffusing capacity for carbon monoxide between 30% and 90% of predicted. Participants must either never have taken specific medications like nintedanib or pirfenidone, be on a stable dose for at least 12 weeks, or have stopped them at least 4 weeks before the study. Life expectancy must be at least 12 months, and participants must agree to use highly effective birth control during the study and for 90 days after the last dose.

Who cannot participate: Patients with respiratory conditions other than idiopathic pulmonary fibrosis, current smokers or those who quit less than six months ago, pregnant or breastfeeding women, people with severe liver or kidney problems, history of heart disease, active infections, participation in other trials within 30 days, known allergies to similar medications, significant abnormal blood test results, history of alcohol or drug abuse, inability to perform breathing tests, mental conditions interfering with study procedures, or life expectancy less than 12 months are excluded.

Study focus: The primary endpoint measures the rate of decline in lung capacity over 26 weeks by assessing forced vital capacity. Researchers will monitor changes in lung function, time to disease worsening, hospitalizations related to breathing problems, and overall health status throughout the study period.

Medication tested: Axatilimab is a monoclonal antibody administered through injection. It targets specific proteins involved in the inflammatory process, aiming to reduce lung damage and improve breathing capacity.

Study on the Effects and Safety of Buloxibutid for Patients with Idiopathic Pulmonary Fibrosis

This 52-week trial examines buloxibutid, taken as an oral capsule, comparing its effectiveness and safety to placebo in managing idiopathic pulmonary fibrosis.

Who can participate: Eligible participants must be 40 years or older with a diagnosis of idiopathic pulmonary fibrosis within the last five years, confirmed by high-resolution CT scan. Forced vital capacity must exceed 50% of predicted, and diffusing capacity must be at least 35% of predicted. Participants must either be on stable doses of approved medications for at least eight weeks or not receiving treatment for specific valid reasons. Life expectancy must be at least 12 months with no expected need for lung transplant during the trial. Women of childbearing potential must use highly effective contraception, and men with partners who can become pregnant must use male condoms and not donate sperm during the trial and for two weeks after.

Who cannot participate: Patients with other lung diseases besides idiopathic pulmonary fibrosis, those with recent lung infections or breathing-related illnesses, individuals who had major surgery within the last three months, current participants in other clinical trials, those with severe heart problems, pregnant or breastfeeding women, people with known allergies to the study medication or its ingredients, individuals with drug or alcohol abuse history in the past year, and those unable to follow study procedures or attend required visits are excluded.

Study focus: The study evaluates how well buloxibutid can improve lung function over one year, specifically measuring forced vital capacity at weeks 4, 12, 24, 36, and 52. Secondary assessments include tracking respiratory-related hospitalizations, acute exacerbations, and changes in symptoms such as cough, shortness of breath, and fatigue through specific questionnaires.

Medication tested: Buloxibutid is an antifibrotic agent currently under investigation in clinical trials. It works by modulating pathways involved in fibrosis, potentially slowing disease progression and improving breathing capacity.

Study on the Effects of CAL101 for Patients with Idiopathic Pulmonary Fibrosis

This 28-week trial evaluates CAL101, administered intravenously, compared to placebo to determine its effectiveness in improving lung function.

Who can participate: Participants must be 40 years or older with a diagnosis of idiopathic pulmonary fibrosis confirmed by high-resolution computed tomography showing definite or probable usual interstitial pneumonia pattern within the last 12 months. Forced vital capacity must be at least 45% of predicted, diffusing capacity for carbon monoxide at least 25% of predicted (corrected for hemoglobin), and the ratio of forced expiratory volume in one second to forced vital capacity at least 0.7. Participants must either be on stable doses of antifibrotic medication (nintedanib or pirfenidone) for at least eight weeks or not have been treated with antifibrotics for at least eight weeks before screening, with expectation to continue current treatment throughout the trial if applicable.

Who cannot participate: Patients without idiopathic pulmonary fibrosis, those not within the specified age range (adults and older adults), and individuals who are part of vulnerable populations such as children, pregnant women, or those unable to give consent are excluded.

Study focus: The primary goal is to assess the effect of CAL101 on forced vital capacity changes over 28 weeks. Researchers will monitor various health parameters including blood sugar levels, heart rate, blood pressure, lung function changes, need for intensive care, and overall well-being throughout the study and for up to 40 weeks to ensure comprehensive safety data.

Medication tested: CAL101 is an investigational drug administered intravenously. It targets specific pathways that may reduce inflammation and scarring in the lungs, although its exact mechanism is still under investigation.

Study on the Safety and Effectiveness of Taladegib for Patients with Idiopathic Pulmonary Fibrosis

This 24-week trial examines taladegib (ENV-101), taken as an oral tablet, evaluating different doses compared to placebo in patients with idiopathic pulmonary fibrosis.

Who can participate: Eligible participants must be 40 years or older with a diagnosis of idiopathic pulmonary fibrosis within the last five years, confirmed by chest high-resolution CT scan taken within 30 days of screening. Forced vital capacity must be 45% or higher of predicted, and diffusing capacity for carbon monoxide at least 25% of predicted (adjusted for hemoglobin) at screening. Participants must be able to perform spirometry tests and either be on stable standard of care treatment (such as antifibrotic medications) for at least three months or not have been treated with standard of care for at least eight weeks before the study starts.

Who cannot participate: Patients with lung conditions other than idiopathic pulmonary fibrosis, those not within the specified age range, individuals unable to follow study procedures or take the medication as required, pregnant or breastfeeding women, recent participants in other clinical trials, those with certain medical conditions that could interfere with study results, and people taking medications that might affect the study results are excluded.

Study focus: The study measures the annual rate of decline in forced vital capacity over the treatment period, with assessments occurring at regular intervals during the 24 weeks. A final evaluation at week 24 measures the absolute change in forced vital capacity from baseline. Regular spirometry tests track lung capacity, and other assessments monitor symptoms such as cough and breathlessness.

Medication tested: ENV-101 (taladegib) is an anti-fibrotic agent administered orally in tablet form. Currently in Phase 2 trials, it targets specific pathways involved in the fibrotic process, aiming to reduce the progression of fibrosis in lung tissue.

Study on Vixarelimab for Patients with Idiopathic Pulmonary Fibrosis and Systemic Sclerosis-Associated Interstitial Lung Disease

This trial evaluates vixarelimab, administered as a subcutaneous injection, compared to placebo to understand its impact on lung function in patients with two types of lung disease over a period of up to 104 weeks.

Who can participate: Participants must have forced vital capacity of at least 45% of predicted, forced expiratory volume to forced vital capacity ratio greater than 0.70, diffusing capacity for carbon monoxide between 30% and 90% of predicted, and ability to walk at least 150 meters in a 6-minute walk test while maintaining oxygen saturation above 83%. For idiopathic pulmonary fibrosis patients, there must be a documented or likely diagnosis according to specific medical guidelines or appropriate high-resolution CT scan patterns. For systemic sclerosis patients, diagnosis must meet specific medical criteria. Both adult and older adult participants of all genders are eligible.

Who cannot participate: Patients with other lung diseases besides the two specified conditions, those not within the age range, pregnant or breastfeeding women, recent participants in other clinical trials, individuals with history of severe allergic reactions to medications, people with uncontrolled medical conditions that could interfere with the study, and those unable to comply with study procedures and visits are excluded.

Study focus: The primary goal is to evaluate how well vixarelimab improves lung function. Throughout the study period, participants undergo regular check-ups including lung function tests, 6-minute walk tests, and quality of life questionnaires. The treatment continues for up to 52 weeks, with monitoring extending to 104 weeks to assess long-term effects.

Medication tested: Vixarelimab is an immunomodulatory agent administered as an injection under the skin. It targets specific proteins involved in inflammation and tissue damage, helping to regulate the immune system’s response and reduce harmful effects in the lungs.

Study of inhaled LTI-03 for safety and effectiveness in patients with Idiopathic Pulmonary Fibrosis who may be receiving standard antifibrotic therapy

This 24-week study examines LTI-03, delivered through a dry powder inhaler, evaluating its safety and effectiveness in idiopathic pulmonary fibrosis patients who may be taking standard treatments.

Who can participate: Eligible participants must be 40 years or older with a diagnosis of idiopathic pulmonary fibrosis within the past five years, confirmed by high-resolution CT scan showing fibrosis affecting at least 10% of lungs. Forced vital capacity must be at least 45% of predicted, and diffusing capacity for carbon monoxide at least 30% of predicted. If taking standard medications (nintedanib, pirfenidone, or nerandomilast), the dose must have been stable for at least 12 weeks. If previously taking these medications, they must have been stopped at least eight weeks before joining. Participants must be able to properly use the inhaler device independently.

Who cannot participate: Individuals with smoking history within the past six months or more than 20 pack-years total, significant lung diseases other than idiopathic pulmonary fibrosis (including active infections), severe heart problems or uncontrolled high blood pressure, major surgery within three months, current participation in other trials or use of investigational drugs within 30 days, severe liver or kidney problems, history of cancer within five years (except successfully treated skin cancer), pregnant or breastfeeding women, inability to perform breathing tests or use the inhaler properly, conditions the study doctor believes would make participation unsafe, history of drug or alcohol abuse within the past year, known allergies to the study medication or its components, and unstable or rapidly progressing condition in the past six months are excluded.

Study focus: The study measures changes in lung function through forced vital capacity measurements and high-resolution CT scans to assess lung fibrosis changes. Researchers also evaluate breathing difficulties and cough through questionnaires, monitor any side effects, and collect blood samples to measure markers related to the condition. Regular assessments occur throughout the 24-week period, with additional follow-up through week 28.

Medication tested: LTI-03 is a novel investigational peptide derived from Caveolin-1-scaffolding protein, administered through inhalation. Currently in Phase 2 trials, it works by interacting with cellular pathways involved in the fibrotic process in lung tissue, potentially helping to slow down or prevent further scarring.

Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis

This trial evaluates MTX-463, administered through intravenous infusion, compared to placebo to assess its safety and effectiveness in improving lung function over 24 weeks.

Who can participate: Participants must be at least 40 years old with a diagnosis of idiopathic pulmonary fibrosis within the last seven years, confirmed by medical tests. Forced vital capacity must be at least 45% of predicted, and diffusing capacity for carbon monoxide (DLCO) at least 25% of predicted. If taking pirfenidone or nintedanib, the dose must have been stable for at least 90 days before screening and must remain stable throughout the study. If previously taking these medications, they must have been stopped at least 30 days before screening. Participants cannot take both medications together during the study. Women who can become pregnant must have negative pregnancy tests at screening, and all participants who can reproduce must use effective birth control during treatment and for 125 days after the last dose.

Who cannot participate: Individuals with history of other respiratory conditions besides idiopathic pulmonary fibrosis (such as asthma, chronic bronchitis, or emphysema), current smokers or those who quit less than six months ago, pregnant or breastfeeding women, people with severe liver or kidney problems, history of heart disease or significant heart problems, active infections including respiratory infections, participation in other trials within 30 days, known allergic reactions to similar medications, people taking certain interacting medications, significant abnormal blood test results, history of alcohol or drug abuse within the past year, inability to perform required breathing tests, mental conditions interfering with study procedures, and life expectancy less than 12 months due to other medical conditions are excluded.

Study focus: The main measurement is the change in lung function (forced vital capacity) from the start to week 24. Additional measurements include changes in the percentage of predicted forced vital capacity. Throughout the study, participants undergo regular physical examinations, vital signs monitoring, laboratory tests, and safety evaluations to track any side effects or adverse reactions.

Medication tested: MTX-463 is a novel investigational drug currently in Phase 2 clinical trials. While the specific mechanism of action and administration route are not yet publicly disclosed as the drug is still in clinical trials, this experimental treatment is being tested against placebo to determine its safety and effectiveness in managing symptoms and potentially slowing disease progression.

Summary

The 23 ongoing clinical trials for idiopathic pulmonary fibrosis represent a diverse approach to treating this challenging condition. Several notable patterns emerge from these studies. Germany leads in trial participation with presence in 17 studies, followed by Italy (14 trials) and Spain (13 trials), suggesting strong research infrastructure in these countries. France, Netherlands, Poland, and Belgium each host 10 or more trials, indicating widespread European research engagement.

The trials examine various treatment approaches including oral medications (tablets and capsules), inhaled therapies delivered through nebulizers or inhalers, and intravenous infusions. Many studies focus on measuring forced vital capacity, a key indicator of lung function, as their primary endpoint. Treatment durations vary considerably, from 12 weeks to ongoing long-term safety studies extending beyond several years.

Several trials specifically target symptom management, particularly chronic cough, which significantly impacts quality of life for patients. Other studies investigate medications that may slow disease progression by targeting inflammatory pathways, fibrotic processes, or specific proteins involved in lung tissue scarring. Some trials build on previous research by continuing to evaluate medications in patients who participated in earlier studies, focusing on long-term safety and tolerability.

Most studies require participants to be at least 40 years old with confirmed diagnosis within the past 5-7 years. Many allow participants to continue their current standard treatments (nintedanib or pirfenidone) while testing additional therapies, reflecting the practical reality of managing this progressive condition. The research represents hope for developing more effective treatments that can improve lung function, reduce symptoms, and enhance quality of life for people living with idiopathic pulmonary fibrosis.

Ongoing Clinical Trials on Idiopathic pulmonary fibrosis

  • Study of MTX-463 compared to placebo to assess its safety and effectiveness in adults with idiopathic pulmonary fibrosis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia France Ireland The Netherlands Spain

  • Study of BI 765423 given by intravenous infusion for patients with idiopathic pulmonary fibrosis with or without standard treatment

    Recruiting

    1
    Investigated diseases:
    Belgium Germany Italy Spain

  • Study of inhaled LTI-03 for safety and effectiveness in patients with Idiopathic Pulmonary Fibrosis who may be receiving standard antifibrotic therapy

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany Poland

  • Long-Term Safety Study of Inhaled Pirfenidone for Patients with Progressive or Idiopathic Pulmonary Fibrosis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy The Netherlands Poland +1

  • Study of tezepelumab in patients with progressive pulmonary fibrosis and increased eosinophil levels in blood

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effects of Methylprednisolone and Prednisone for Treating Acute Flare-Ups in Idiopathic Pulmonary Fibrosis Patients

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Long-Term Study of BI 1015550 for Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Czechia Denmark Estonia +14

  • A study to evaluate the safety and effectiveness of zampilimab in people with idiopathic pulmonary fibrosis

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Italy +4

  • Study to evaluate the safety and effectiveness of inhaled nintedanib in patients with idiopathic pulmonary fibrosis

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Spain

  • A study of the humanised IgG1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1 to treat adults with idiopathic pulmonary fibrosis

    Not yet recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Greece Hungary Italy +5

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