Studying tozorakimab for long-term safety in patients with chronic obstructive pulmonary disease

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    What is this study about?

    The research study focuses on Tozorakimab’s long-term safety and efficacy in adults over 40 with frequent COPD flare-ups. It aims to evaluate the time until the first severe flare-up post-treatment, comparing it with the effects of current COPD treatments. The study also assesses Tozorakimab’s additional benefits alongside standard care and monitors participants’ blood for drug levels and physiological reactions. This research is key in developing improved management strategies for COPD.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Bruxelles , Belgium

      Gent , Belgium

      Leuven , Belgium

      Liege , Belgium

      Namur , Belgium

      Dupnitsa , Bulgaria

      Kozloduy , Bulgaria

      Lovech , Bulgaria

      Petrich , Bulgaria

      Ruse , Bulgaria

      Sliven , Bulgaria

      Sofia , Bulgaria

      Brno , Czechia

      Broumov , Czechia

      Jindrichuv Hradec , Czechia

      Liberec 1 , Czechia

      Olomouc , Czechia

      Rokycany , Czechia

      Hvidovre , Denmark

      Ku00f8benhavn NV , Denmark

      Naestved , Denmark

      Roskilde , Denmark

      Vejle , Denmark

      u00c5lborg , Denmark

      Helsinki , Finland

      Hu00e4meenlinna , Finland

      Kuopio , Finland

      Tampere , Finland

      Turku , Finland

      Brest Cedex , France

      Dijon Cedex , France

      Lyon Cedex 04 , France

      MARSEILLE cedex 15 , France

      Montpellier Cedex 5 , France

      Bamberg , Germany

      Berlin , Germany

      Berlin , Germany

      Darmstadt , Germany

      Grou00dfhansdorf , Germany

      Halle , Germany

      Ku00f6ln , Germany

      Marburg , Germany

      Mu00fcnchen-Pasing , Germany

      Mu00fcnchen , Germany

      Peine , Germany

      Alexandroupolis , Greece

      Athens , Greece

      Exohi Thessaloniki , Greece

      Ioannina , Greece

      Patras , Greece

      Thessaloniki , Greece

      Budapest , Hungary

      Encs , Hungary

      Mosonmagyaru00f3vu00e1r , Hungary

      Szu00e1zhalombatta , Hungary

      Bari , Italy

      Carrara , Italy

      Milano , Italy

      Milano , Italy

      Napoli , Italy

      Roma , Italy

      Salerno , Italy

      Sassari , Italy

      Statte , Italy

      Telese Terme , Italy

      Tradate , Italy

      Vercelli , Italy

      Verona , Italy

      Groningen , Netherlands

      Harderwijk , Netherlands

      Heerlen , Netherlands

      Zutphen , Netherlands

      Zwolle , Netherlands

      Bodu00f8 , Norway

      Lu00f8renskog , Norway

      Oslo , Norway

      Tu00f8nsberg , Norway

      Biau0142ystok , Poland

      Bydgoszcz , Poland

      Katowice , Poland

      Krakow , Poland

      Lublin , Poland

      Ostrowiec u015awiu0119tokrzyski , Poland

      Ostru00f3da , Poland

      Poznau0144 , Poland

      Poznau0144 , Poland

      Rzeszu00f3w , Poland

      Wrocu0142aw , Poland

      Lisboa , Portugal

      Lisboa , Portugal

      Matosinhos , Portugal

      Vila Nova de Gaia , Portugal

      Brasov , Romania

      Cluj-Napoca , Romania

      Constanta , Romania

      Timisoara , Romania

      Galdakao , Spain

      Madrid , Spain

      Malaga , Spain

      Mu00e9rida , Spain

      Pozuelo de Alarcon , Spain

      Santander , Spain

      Valencia , Spain

      Zaragoza , Spain

      Gu00f6teborg , Sweden

      Gu00f6teborg , Sweden

      Lund , Sweden

      Malmu00f6 , Sweden

      Stockholm , Sweden

      Bradford , United Kingdom

      Corby , United Kingdom

      Northwood , United Kingdom

      Preston , United Kingdom


      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 include:

      1. Having completed the treatment period and not being prematurely discontinued from investigational product (IP) in the predecessor studies.
      2. Receiving the last dose of IP in the predecessor studies within the previous 12 weeks and not being withdrawn from the predecessor study.
      3. For females of childbearing potential (FOCBP), having a negative urine pregnancy test at Visit 1.
      4. Willingness to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
      5. Capability of giving signed informed consent.

      There are also certain exclusion criteria to consider, such as having a clinically significant disorder or abnormal findings that might put the participant at risk, concurrent enrollment in other interventional clinical studies (apart from OBERON or TITANIA predecessor studies), known history of severe allergic reactions to monoclonal or polyclonal antibodies, chronic use of immunosuppressive medications, and an inability to comply with the study requirements, procedures, and restrictions.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, there are specific exclusion criteria related to diseases and health conditions. You are not eligible to join the study if you:

      1. Have any clinically significant disorder or abnormal findings, or major physical and/or cognitive impairment that the Investigator believes may put you at risk due to participation in the study, affect the interpretation of the study results, or make your participation inappropriate.
      2. Meet criteria for investigational product (IP) discontinuation as judged by the Investigator or the Sponsor.
      3. Are concurrently enrolled in other interventional clinical studies or treated with another IP, except for the OBERON and TITANIA predecessor studies.
      4. Have a known history of:
        1. Severe allergic reaction to any monoclonal and polyclonal antibody.
        2. Allergy or reaction to any component of the IP formulation.
      5. Require chronic use (or are expected to need chronic use during the study) of immunosuppressive medications, including systemic corticosteroids, marketed or investigational biologic, or another prohibited medication.
      6. Are involved in the planning and/or conduct of the study (this applies to both staff employed by the Sponsor and staff at the study site).
      7. Are not able to comply with the study requirements, procedures, and restrictions.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The conditions you must meet to join the study are as follows:

      1. Completion of the treatment period in predecessor studies: You must have completed the treatment period and have not been prematurely discontinued from the Investigational Product (IP) during the predecessor studies.
      2. Recent IP administration: You should have received your last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the study.
      3. Negative pregnancy test for females of childbearing potential (FOCBP): If you are a female of childbearing potential, you must have a negative urine pregnancy test at Visit 1.
      4. Contraceptive use: You must be willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
      5. Informed consent: You must be capable of giving signed informed consent, meaning you understand the study’s procedures, risks, benefits, and that you agree to participate voluntarily.

      To clarify the medical terms:
      Investigational Product (IP): IP refers to the drug or treatment that is being tested in the clinical trial.
      Females of childbearing potential (FOCBP): This term refers to women who are capable of becoming pregnant, which usually includes those who have entered puberty and have not yet gone through menopause.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude a participant from the study, along with explanations for any medical terms used:

      1. Significant health disorders or abnormalities: If the participant has any serious health issues, abnormal findings from clinical evaluations, lab tests, instrumental tests, major physical disability, or cognitive impairment that the investigator believes could put the participant at risk by being in the study, affect the interpretation of the study results, or for any other reason make the participant’s involvement inappropriate.
      2. Criteria for IP discontinuation: If the participant meets any criteria established by the Investigator or the Sponsor for discontinuing the investigational product (IP), they cannot participate.
      3. Enrolment in other clinical studies: Participants already enrolled in other interventional clinical studies or who are receiving treatment with another investigational product, except for those in the OBERON and TITANIA predecessor studies.
      4. Allergic reactions: If the participant has a known history of:
        1. Severe allergic reaction to any monoclonal and polyclonal antibodies.
        2. Allergy or reaction to any component of the IP formulation.
      5. Use of immunosuppressive medications: If the participant uses, or is expected to need chronic use during the study of, immunosuppressive medications (including systemic corticosteroids), marketed or investigational biologics, or other prohibited medications. Immunosuppressive medications weaken the body’s immune response and may interfere with the study’s objectives.
      6. Involvement in the study’s planning/conduct: If the participant is involved in the planning or conduct of the study (this applies to both staff employed by the Sponsor and staff at the study site).
      7. Inability to comply with study requirements: If the participant is unable to comply with the study’s requirements, procedures, and restrictions.

      These conditions are outlined to ensure the safety of the participants and the integrity of the study data.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the drug Tozorakimab. Below is a brief description:

      1. Tozorakimab: While the specific active substance detail for Tozorakimab is not provided in the document, typically such drugs are monoclonal antibodies used for therapeutic purposes. They are designed to target specific antigens found on certain diseases or markers in the body and can be used to treat a variety of conditions, including chronic inflammatory diseases and certain types of cancers.

      In the context of this study, Tozorakimab is being used to evaluate its safety and efficacy in adult participants with symptomatic Chronic Obstructive Pulmonary Disease (COPD). If you require more detailed information about Tozorakimab, such as its molecular structure or mechanism of action, please let me know, and I can attempt to find more specifics.

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

      The active substance being tested in the clinical trial is:

      1. Tozorakimab: Participants who were previously randomized to Tozorakimab in one of the predecessor studies will continue to be assigned the same Tozorakimab dose and regimen in the PROSPERO study.

      As for whether Tozorakimab is already known to medicine and the medical literature, this would require further research outside the provided clinical trial document. However, given that it is mentioned as a combination product in the trial, it is likely under investigation and may not yet be widely known or approved for general use in medicine.


      Study ID

      CT-EU-00029848

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product

      Diseases