Testing astegolimab’s effectiveness in chronic obstructive pulmonary disease patients

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    What is this study about?

    A clinical research study is being conducted to examine the efficacy and safety of a novel treatment known as astegolimab in the management of Chronic Obstructive Pulmonary Disease (COPD). The study is particularly focused on individuals with a history of COPD who are either current or former smokers and have experienced frequent exacerbations. Within the scope of this study, astegolimab’s therapeutic potential is being compared to that of a placebo. Participants enrolled in the trial will be administered the study medication at intervals of either every 2 or 4 weeks. Key parameters under evaluation include the frequency of COPD exacerbations, variations in the quality of life of the participants, and changes in lung function over the course of the study. The study aims to contribute valuable data to medical research, particularly in understanding the treatment dynamics of astegolimab in COPD management.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Feldbach , Austria

      Linz , Austria

      Brugge , Belgium

      Brussels , Belgium

      Bruxelles , Belgium

      Liu00e8ge , Belgium

      Blagoevgrad , Bulgaria

      Dimitrovgrad , Bulgaria

      Gabrovo , Bulgaria

      Plovdiv , Bulgaria

      Razgrad , Bulgaria

      Silistra , Bulgaria

      Smolyan , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Varna , Bulgaria

      Veliko Tarnovo , Bulgaria

      Brandys nad Labem-Stara Boleslav , Czechia

      Kyjov , Czechia

      Opava , Czechia

      Praha 1 , Czechia

      Praha , Czechia

      Tabor , Czechia

      Teplice , Czechia

      Nu00e6stved , Denmark

      Roskilde , Denmark

      Amiens , France

      Paris , France

      Pessac , France

      Vandoeuvre , France

      Berlin , Germany

      Berlin , Germany

      Berlin , Germany

      Darmstadt , Germany

      Frankfurt , Germany

      Frankfurt , Germany

      Hamburg , Germany

      Hamburg , Germany

      Hannover , Germany

      Heidelberg , Germany

      Immenhausen , Germany

      Leipzig , Germany

      Leipzig , Germany

      Lu00fcbeck , Germany

      Magdeburg , Germany

      Mu00fcnchen , Germany

      Neu-Isenburg , Germany

      Rheine , Germany

      Rosenheim , Germany

      Alexandroupolis , Greece

      Athens , Greece

      Athens , Greece

      Athina , Greece

      Heraklio , Greece

      Ioannina , Greece

      Thessaloniki , Greece

      Csorna , Hungary

      Farkasgyepu , Hungary

      Napoli , Italy

      Pavia , Italy

      Palermo , Italy

      Florence , Italy

      Amersfoort , Netherlands

      Groningen , Netherlands

      Heerlen , Netherlands

      Bia?ystok , Poland

      Bydgoszcz , Poland

      Bydgoszcz , Poland

      Chojnice , Poland

      Cz?stochowa , Poland

      Gda?sk , Poland

      Gdynia , Poland

      Grudzadz , Poland

      Grudziadz , Poland

      Katowice , Poland

      Krakow , Poland

      Ksaweru00f3w , Poland

      Lodz , Poland

      Lodz , Poland

      Lublin , Poland

      Lublin , Poland

      Radom , Poland

      Slupsk , Poland

      Sopot , Poland

      Sosnowiec , Poland

      Szczecin , Poland

      Tarnow , Poland

      Torun , Poland

      Trzebnica , Poland

      Warszawa , Poland

      Wroc?aw , Poland

      Wroc?aw , Poland

      Wroclaw , Poland

      Zabrze , Poland

      Cluj-Napoca , Romania

      Craiova , Romania

      Timisoara , Romania

      Palma de Mallorca , Spain

      Ponferrada , Spain

      Torrejon de Ardoz , Spain

      Benalmadena Costa , Spain

      Alzira , Spain

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Sevilla , Spain

      Valencia , Spain

      Valencia , Spain

      Goteborg , Sweden

      Linkoping , Sweden

      Orebro , Sweden

      Solna , Sweden

      Stockholm , Sweden

      Uppsala , Sweden

      Bellshill , United Kingdom

      Cardiff , United Kingdom

      Chesterfield , United Kingdom

      Chorley , United Kingdom

      Corby , United Kingdom

      Cottingham , United Kingdom

      Coventry , United Kingdom

      Edgbaston , United Kingdom

      Hexham , United Kingdom

      Lancaster , United Kingdom

      Liverpool , United Kingdom

      Manchester , United Kingdom

      Norwich , United Kingdom


      Study Steps

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

      In this clinical trial, patients will be required to receive subcutaneous (SC) injections of astegolimab every 2 weeks.


      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, Obstructive
      3. Pulmonary Disease, Chronic Obstructive

      These are categorized under Respiratory Tract Diseases.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study along with explanations of medical terms where necessary:

      Inclusion Criteria:

      1. Documented COPD diagnosis for ≥ 12 months: You must have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least one year.
      2. History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening: An ‘exacerbation’ is a worsening or a flare-up of COPD symptoms such as increased breathlessness, coughing, and phlegm. You should have experienced at least two of these events within the last year before screening for the trial.
      3. Post-bronchodilator FEV1 ≥ 20% and < 80% of predicted at screening: ‘FEV1’ stands for Forced Expiratory Volume in the first second, which measures how much air you can forcefully exhale in one second. For this trial, your FEV1 after using a bronchodilator (a medication to open airways) must be between 20% and 80% of the expected value for someone of your age, gender, and size.
      4. Post-bronchodilator FEV1/FVC < 0.70 at screening: ‘FVC’ stands for Forced Vital Capacity, the total amount of air you can exhale forcefully after a full inhalation. The FEV1/FVC ratio compares FEV1 to FVC to diagnose and determine the severity of COPD. A ratio of less than 0.70 indicates airflow limitation consistent with COPD.
      5. Modified Medical Research Council (dyspnea scale) (mMRC) score ≥ 2: The ‘mMRC’ scale is a simple scale to assess the degree of breathlessness. A score of 2 or more indicates at least a moderate difficulty in breathing, such as being unable to walk more than 100 yards or climb a flight of stairs without stopping due to breathlessness.
      6. Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years: This refers to the amount of smoking over a person’s lifetime. One ‘pack-year’ is equivalent to smoking 20 cigarettes (one pack) every day for one year. To qualify, you must have smoked this amount or more.
      7. On optimized COPD maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: You should have been on a stable and optimized regimen for treating COPD for one year or more, and no changes should have been made in the last four weeks. Regimens include combinations of medications such as Inhaled corticosteroids (ICS), Long-acting beta-agonists (LABA), and/or Long-acting muscarinic antagonists (LAMA).
      8. Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD: This imaging is needed to ensure that no other significant lung conditions are present aside from COPD.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      1. Current documented diagnosis of asthma: Asthma is a respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing.
      2. History of clinically significant pulmonary disease other than COPD: This refers to serious lung diseases that affect breathing, which are not COPD (Chronic Obstructive Pulmonary Disease).
      3. Diagnosis of 1-antitrypsin deficiency: This is a genetic disorder that can cause lung and liver disease.
      4. History of long-term treatment with oxygen at > 4.0 liters/minute: This implies the person has been on high-flow oxygen therapy, which can indicate severe respiratory impairment.
      5. Lung volume reduction surgery or procedure within 12 months prior to screening: This surgery is performed to remove diseased tissue from the lungs, which can affect how medications or interventions work in a trial.
      6. Individuals participating in, or scheduled for, an intensive COPD rehabilitation program: However, those in the maintenance phase of a rehab program can still be eligible.
      7. History of lung transplant: This is a surgical procedure to replace a diseased or failing lung with a healthy lung, usually from a deceased donor.
      8. Any infection resulting in hospital admission for ≥ 24 hours or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening: This could affect the participant’s immune response or interaction with the study drug.
      9. Upper or lower respiratory tract infection within 4 weeks prior to or during screening: Such infections can complicate the assessment of the study drug effects.
      10. Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug: Steroids can influence the immune system and the response to the study drug.
      11. Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening: These therapies can affect immune function and potentially conflict with the study objective.
      12. Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening: These heart conditions can increase risk in the study and potentially interfere with outcomes.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are as follows:

      1. Astegolimab – Participants will receive subcutaneous (SC) astegolimab either every 2 weeks (Q2W) or alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab every 4 weeks (Q4W). Astegolimab is the trade name; and it is an experimental monoclonal antibody designed to reduce inflammation by targeting the interleukin-33 (IL-33) pathway, which is believed to play a key role in various inflammatory diseases, including Chronic Obstructive Pulmonary Disease (COPD).
      2. Placebo – A placebo does not contain an active substance and is used to compare against the effects of Astegolimab. Participants will receive SC placebo Q2W (every 2 weeks).

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

      The active substances participating in the clinical trial include:

      1. Astegolimab: Participants will receive subcutaneous (SC) astegolimab either every 2 weeks (Q2W) or every 4 weeks (Q4W) depending on the specific arm of the study they are in. Astegolimab is currently being studied and is not yet known in the medical literature as an approved treatment for Chronic Obstructive Pulmonary Disease (COPD), it is the main focus of this clinical trial.

      Study ID

      CT-EU-00041968

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases