Testing tulisokibart’s effects on systemic sclerosis related lung disease

Recruting new patients

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    What is this study about?

    This is a study about the safety and effectiveness of a drug called tulisokibart for people with a specific lung disease often seen in patients with a disease called systemic sclerosis. The lung disease makes it hard for them to breathe because their lung tissues are becoming thick and hard. In this trial, some patients will get tulisokibart and others will get a placebo (a pill without any active medicine). Everyone will be watched closely for any negative reactions, such as unwanted symptoms or health problems. To check how well the drug works, they there will be done a few tests.

    Learn more about this Trial

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      Where does the clinical trial take place?

      Gent , Belgium

      Leuven , Belgium

      Liege , Belgium

      Bordeaux , France

      Lille , France

      Paris , France

      Freiburg , Germany

      Bad Nauheim , Germany

      Hohenfelde B Bad Doberan , Germany

      Ku00f6ln , Germany

      Pecs , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Pavia , Italy

      Torino , Italy

      Firenze , Italy

      Genova , Italy

      Reggio Emilia , Italy

      Roma , Italy

      Nijmegen , Netherlands

      Oslo , Norway

      Wroclaw , Poland

      Bydgoszcz , Poland

      Warszawa , Poland

      Biau0142ystok , Poland

      Bytom , Poland

      Poznau0144 , Poland

      Warszawa , Poland

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Malaga , Spain

      Valencia , Spain

      London , United Kingdom

      Leeds , United Kingdom

      You can join this study in:

      Germany: Bad Nauheim.

      Spain: Barcelona, Madrid.

      France: Bordeaux, Lille, Paris.

      Hungary: Budapest, Debrecen, Pécs.

      Poland: Bydgoszcz, Bytom, Wrocław.

      United Kingdom: Leeds.

      Belgium: Leuven, Liège.

      Netherlands: Nijmegen.

      Norway: Oslo.

      Italy: Pavia, Reggio Emilia.

      Study Steps

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

      The steps a patient needs to take in this clinical trial involve meeting specific inclusion criteria and complying with the study requirements:

      1. Having a confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
      2. Having diffuse cutaneous scleroderma.
      3. Having systemic sclerosis-related interstitial lung disease confirmed by High-Resolution Computer Tomography (HRCT).
      4. Forced Vital Capacity (FVC) ≥ 45% of predicted normal.
      5. Diffusing capacity of lung for carbon monoxide (DLCO) ≥ 45% of predicted normal.
      6. If on background therapy, patient must meet stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX), azathioprine, and corticosteroids.
      7. For women of childbearing potential, they must not be pregnant or breastfeeding and must be willing to use an acceptable contraceptive method or be sexually abstinent.
      8. Ability to provide written informed consent and understand and comply with the requirements of the study.

      The patient also needs to fulfill any other study-specific procedures or requirements, which may include taking the investigational drug or placebo as directed and participating in any scheduled assessments or visits throughout the study. If you need more details about the specific procedures, drug dosages, or schedule within this clinical trial, please let me know so I can provide further information.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have one of the following diseases:

      1. Lung Diseases
      2. Lung Diseases, Interstitial
      3. Scleroderma, Systemic
      4. Scleroderma, Diffuse
      5. Sclerosis


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is the list of conditions you must meet to join the study, along with explanations of medical terms:

      1. Confirmed diagnosis of systemic sclerosis with onset of the disease ≤ 5 years ago
        Systemic Sclerosis (SSc) is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The ≤ 5 years condition means your diagnosis must have been within the last 5 years from the present.
      2. Diffuse cutaneous scleroderma
        Diffuse cutaneous scleroderma is a subset of systemic sclerosis characterized by skin thickening across much of the body, which can also involve the internal organs.
      3. Systemic sclerosis-related interstitial lung disease confirmed by HRCT
        Interstitial lung disease (ILD) involves the inflammation and scarring of lung tissue and is associated with systemic sclerosis. HRCT stands for High-Resolution Computed Tomography, which is an imaging method used to diagnose ILD.
      4. FVC ≥ 45% of predicted normal
        Forced Vital Capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. A value ≥ 45% of predicted indicates that your lung function is at least 45% of what is expected for your age, sex, height, and ethnicity.
      5. Diffusing capacity of lung for carbon monoxide (DLCO) ≥ 45% of predicted normal
        DLCO measures how well oxygen passes from the lungs into the blood. A ≥ 45% of predicted implies your lungs are still effective at transferring oxygen to a certain level.
      6. If on background therapy, meets stable dosing requirements for nintedanib, mycophenolate mofetil (MMF), methotrexate (MTX), or azathioprine, and corticosteroids
        This means if you’re currently receiving any of these medications for systemic sclerosis, you must be on a stable dose before entering the trial.
      7. Women of childbearing potential must not be pregnant or breastfeeding and must either be willing to use an acceptable contraceptive method or be sexually abstinent
        This is a safety measure to prevent any potential risks to an unborn or nursing child.
      8. Able to provide written informed consent and understand and comply with the requirements of the study
        You must be capable of understanding what participation involves, agree to it in writing, and follow the study protocols.

      This information can be verified in the inclusion criteria section of the trial document.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Airway obstruction per pulmonary function test (PFT) or clinically significant pulmonary arterial hypertension: If you have limitations in airflow within the lungs or high blood pressure in the arteries of the lungs, you cannot participate in the study.
      2. Current clinical diagnosis of another inflammatory connective tissue disease: If you have been diagnosed with a disease that affects connective tissues and causes inflammation, other than systemic sclerosis, you cannot participate.
      3. Any active infections, a serious infection within the past 3 months, or chronic bacterial infection: If you currently have an infection, have had a serious infection recently, or suffer from recurring bacterial infections, you are not eligible for the study.
      4. Current smoker or smoking within 6 months of screening: If you are currently smoking or have smoked in the six months leading up to the screening, you cannot take part in the study.
      5. Concomitant medical conditions that might place you at unacceptable risk: If you have other medical conditions that could increase your risk of harm by participating in the study, as determined by the investigator, you are excluded from participating.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Tulisokibart (active substance unspecified) – This is the experimental drug administered by IV infusion as part of the treatment arm in the study. Currently, the detailed description of the active substance for Tulisokibart is not provided in the document. It is listed under the intervention names “Drug: Tulisokibart” and has other names “PRA023,” “MK-7240”.
      2. Placebo (inactive substance) – The placebo is administered by IV infusion and is part of the control arm in the study. A placebo is generally a substance with no therapeutic effect, used as a control in testing new drugs.

      Since active substances are typically specified unless the information is proprietary or the drug is being used under a code name for trial purposes, the active substance of Tulisokibart was not directly stated. If there is need for a more detailed explanation of the active substance, further research beyond the provided document may be required.

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

      The clinical trial includes an experimental drug called Tulisokibart. Here is more information on the active substances used in the trial:

      1. Tulisokibart: This is the experimental drug used in the clinical trial. It is listed under the interventions as “Tulisokibart administered at timepoints as directed by the protocol,” which indicates that it is being used actively in the trial and dosed as per the study design. It is known within the study by its proprietary name and by the code MK-7240.
      2. Placebo: Placebos are typically inactive substances used as a control in clinical trials. Although they do not have any therapeutic effect, they are important to help determine the effectiveness of the experimental drug by comparing outcomes between the experimental group and the placebo group.

      Please note that the information provided herewithin is derived directly from the documentation of the clinical trial and these substances’ prior knowledge in medicine and medical literature is not detailed in the brief. For comprehensive insights into Tulisokibart’s scientific background and literature presence, further research and consultation with medical databases or peer-reviewed journals will be necessary.

      Study ID


      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase


      Medicinal Product