Testing the safety and effectiveness of a new drug in the treatment of pulmonary fibrosis

Recruting new patients

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    What is this study about?

    This study is testing a new drug called BMS-986278 for a lung disease called progressive pulmonary fibrosis. This condition causes the lungs to become increasingly scarred over time, making breathing difficult. Randomly assigned participants will receive either the real drug or a fake drug (placebo) that doesn’t work. No one will know who gets what, not even doctors. The goal is to see if this new drug helps slow the progression of the disease, prevent patients from having to be hospitalized and/or increase their chances of survival. These outcomes will be measured by tracking breathing tests, any sudden, serious worsening of the disease, any hospital stays related to lung disease, and any deaths from any cause.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Linz , Austria

      Salzburg , Austria

      Graz , Austria

      Vienna , Austria

      Godinne-Mont , Belgium

      Leuven , Belgium

      Brussels , Belgium

      Liege , Belgium

      Olomouc , Czechia

      Aarhus , Denmark

      Odense C , Denmark

      Copenhagen , Denmark

      Hellerup , Denmark

      Helsinki , Finland

      Turku , Finland

      Bron , France

      Grenoble , France

      Marseille , France

      Bobigny , France

      Brest , France

      Dijon Cedex , France

      Nice , France

      Paris , France

      Toulouse , France

      Tours , France

      Paris , France

      Munich , Germany

      Berlin , Germany

      Freiburg I. Breisgau , Germany

      Munnerstadt , Germany

      Immenhausen , Germany

      Hamburg , Germany

      Coswig , Germany

      Heidelberg , Germany

      Mainz , Germany

      Maroussi , Greece

      Ioannina , Greece

      Heraklion , Greece

      Athens , Greece

      Larisa , Greece

      Rio , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Gyu00f6r , Hungary

      Ancona , Italy

      Modena , Italy

      Milano , Italy

      Pisa , Italy

      Roma , Italy

      Bergamo , Italy

      Foggia , Italy

      Milano , Italy

      Milan , Italy

      Monza , Italy

      Napoli , Italy

      Pavia , Italy

      Sassari , Italy

      Heerlen , Netherlands

      Leiden , Netherlands

      Rotterdam , Netherlands

      Nieuwegein , Netherlands

      Amsterdam , Netherlands

      Amsterdam , Netherlands

      Bydgoszcz , Poland

      Bialystok , Poland

      Gdansk , Poland

      Bedzin , Poland

      Katowice , Poland

      Braga , Portugal

      Lisboa , Portugal

      Porto , Portugal

      Porto , Portugal

      Vila Nova de Gaia , Portugal

      Oviedo , Spain

      Barcelona , Spain

      Valencia , Spain

      Santiago de Compostela , Spain

      Madrid , Spain

      Madrid , Spain

      Majadahonda , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Pamplona , Spain

      Bristol , United Kingdom

      Cambridge , United Kingdom

      Dundee , United Kingdom

      Edinburgh , United Kingdom

      Southampton , United Kingdom

      South Shields , United Kingdom

      Leeds , United Kingdom

      Cottingham , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      I apologize for the inconvenience, there seems to be a difficulty in extracting the exact quote from the document. However, I can provide you with the information I found.

      The steps a patient needs to take in this clinical trial involve taking the investigational drug BMS-986278 or its placebo counterpart. The description indicates a “specified dose on specified days,” suggesting that the trial protocol requires participants to adhere to a predefined dosing schedule. However, the exact dosing details and the schedule are not provided in the section accessible to me.

      For precise information about the dosing regimen and the treatment schedule, typically, you would be given detailed instructions by the research team once you are enrolled in the trial. These instructions would include how much of the drug to take, how often, and any specific conditions you need to follow while taking it. The research team would monitor your adherence to the protocol, as well as your health and safety throughout the trial period. If you have further questions or require more details, it is best to contact the trial’s research staff directly or refer to the patient information that was provided to you upon enrollment in the trial.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, as well as at least 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria with Explanations:

      1. Diagnosis of interstitial lung disease (ILD) with progressive features:
        You must have been diagnosed with ILD, and it must show progressiveness within the last 24 months. The diagnosis should be confirmed through a high-resolution computed tomography (HRCT) with an extent of fibrosis being 10% or more.

        • Interstitial lung disease (ILD): A group of diseases that cause scarring (fibrosis) of the lungs, leading to shortness of breath and reduced oxygen levels in the bloodstream.
        • Fibrosis: This is the thickening and scarring of connective tissue, usually as a result of an injury.
        • High-resolution computed tomography (HRCT): An imaging method that provides detailed pictures of the lungs and is particularly useful for detecting lung diseases.
      2. Medication Stability: If you are currently taking pirfenidone or nintedanib, antifibrotic medications, you have been on a stable dose for at least 90 days. If you’re not on these medicines, you haven’t taken them in the last 28 days.
      3. Stability on certain immunosuppressants: If taking mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), or tacrolimus, you must be on a stable dose for 90 days. If not currently on these medications, you haven’t taken them within the last 28 days.
      4. Stability on traditional DMARDs: You are eligible if you’re on a stable dose of traditional disease-modifying antirheumatic drugs like methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine for 90 days. If not currently on these, none should have been taken in the last 28 days.
      5. Stability on Biologic DMARDs or JAK inhibitors: Similar to the traditional DMARDs, stable doses of biologic DMARDs (like TNF blockers or IL-1 inhibitors) and JAK inhibitors (like tofacitinib, upadacitinib) for 90 days are required, or not having taken them in the last 28 days.
      6. Contraception and pregnancy testing for women of childbearing potential: You need to be on a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
      7. Contraception agreement for men: If you are a man who is sexually active with a woman of childbearing potential, you agree to use male barrier contraception.

      These conditions ensure that participants have a stabilized condition and medication use, and they address safety concerns for potential effects on reproductive health.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude you from participating in the study, along with explanations of medical terms:

      Exclusion Criteria

      1. Idiopathic Pulmonary Fibrosis with Usual Interstitial Pneumonia (UIP) verification at screening: A specific type of chronic, progressive lung disease characterized by scarring of the lungs, which is confirmed through clinical assessments.
      2. History of stroke or transient ischemic attack within 3 months prior to screening: A stroke is when blood flow to an area of the brain is cut off, while a transient ischemic attack (TIA), often called a mini-stroke, is a temporary blockage that causes similar symptoms but usually has no lasting effects. Both conditions could impact a patient’s suitability for the study.
      3. Participants who exhibit symptoms of heart failure at rest: Heart failure is a condition where the heart is unable to pump sufficiently to maintain blood flow to meet the body’s needs, especially noticeable without activity.
      4. Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening: ‘Malignancy’ refers to cancer. However, certain skin cancers like nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, and cervical carcinoma in situ which have been cured are exceptions.
      5. Use of systemic corticosteroids equivalent to prednisone > 15 mg/day is not allowed within 4 weeks prior to screening and during the study: Systemic corticosteroids are anti-inflammatory drugs that might affect the study’s parameters, and prednisone is one such example. A dosage greater than 15 mg/day is not permitted.

      These criteria help ensure the safety of the participants and the validity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. BMS-986278 – This is an LPA1 antagonist. Lysophosphatidic acid 1 (LPA1) is a receptor subtype for lysophosphatidic acid (LPA), a molecule involved in various cellular processes, including cell proliferation, platelet aggregation, and smooth muscle contraction. Antagonists of the LPA1 receptor are being investigated for their potential therapeutic effects in conditions such as fibrosis, due to their ability to modulate the biological pathways that lead to the accumulation of fibrous tissue.

      Additionally, there is a placebo group using a BMS-986278 Placebo, which does not contain an active substance but is used to compare the effects of BMS-986278 against a control group. The placebo is designed to look like the actual drug but does not provide any therapeutic benefit. The purpose of the placebo is to determine the drug’s efficacy by comparing the differences in outcomes between the treatment group and the placebo group.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are as follows:

      1. BMS-986278: This is the experimental drug being tested in two different dosages as part of the clinical trial. There is currently no information provided in the available data about whether BMS-986278 is known to medicine or the medical literature. Its efficacy, safety, and tolerability are being evaluated in participants with Progressive Pulmonary Fibrosis.
      2. BMS-986278 Placebo: A placebo version of the drug BMS-986278 is also being used in the trial. The placebo serves as a comparator to measure the actual effect of the experimental drug against no therapeutic intervention.

      Please note that placebos generally contain no active medicinal ingredients and are used to assess the psychological and physiological effects of the experimental substance in a controlled environment.


      Study ID

      CT-EU-00038773

      Recruitment status

      Recruting new patients

      Start of the trial

      8 months ago