Study of Tozorakimab to reduce exacerbations in former smokers with chronic obstructive pulmonary disease (COPD)

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What is this study about?

This clinical trial focuses on testing a medication called Tozorakimab in people with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and persistent cough with mucus. The study aims to determine how well two different dose schedules of Tozorakimab work in reducing the frequency of disease flare-ups in former smokers who experience COPD symptoms.

The study medication Tozorakimab will be given as an injection under the skin, alongside the regular COPD treatments that participants are already taking. Some participants will receive Tozorakimab while others will receive placebo, in addition to their standard COPD medications. Participants may also use salbutamol, a rescue inhaler medication that helps to quickly relieve breathing difficulties when needed.

The study will last for 52 weeks, during which participants will need to attend regular clinic visits for health assessments. Throughout the study, doctors will monitor how often participants experience COPD flare-ups, which are periods when their symptoms become notably worse than usual. These flare-ups can range from moderate to severe and may require additional medical treatment.

1 Initial screening

Your eligibility for the study will be confirmed based on specific criteria, including:

– Age 40 years or older

– Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least one year

– History of breathing problems in the past 12 months

– Current use of inhaled medications for at least 3 months

– Past smoking history of 10 pack-years or more

– Specific breathing test results will be required

2 Treatment assignment

You will be randomly assigned to receive one of three treatments:

Tozorakimab injection under the skin at one of two different dose levels

– Placebo injection (contains no active medication)

All participants will continue their regular COPD medications throughout the study

3 Treatment period

The study will continue until May 2026

You will receive regular injections under the skin

Your regular inhaled medications will continue as prescribed

Salbutamol inhaler will be provided as rescue medication when needed

4 Monitoring

Regular assessments will track your COPD symptoms

Any breathing problems or COPD exacerbations (worsening of symptoms) will be recorded

Your breathing function will be tested periodically

Your overall health and safety will be monitored throughout the study

Who Can Join the Study?

  • Must be at least 40 years old and able to provide signed informed consent
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least 1 year before joining the study
  • Must have specific lung function test results showing:
    • A ratio of FEV1/FVC less than 0.70 (This measures how much air you can exhale)
    • A FEV1 greater than 20% of what would be normal for you
  • Must have experienced in the past 12 months either:
    • At least 2 moderate flare-ups of COPD, or
    • At least 1 severe flare-up of COPD
  • Must be using prescribed inhaled medications (either two or three different types) at a stable dose for at least 3 months
  • Must have a history of smoking at least 10 pack-years (For example: smoking 1 pack per day for 10 years, or 2 packs per day for 5 years)
  • Must score 10 or higher on the CAT assessment (a questionnaire that measures COPD symptoms), with scores of 2 or higher for both cough and phlegm symptoms

Who Cannot Join the Study?

  • Active or former smokers who have quit smoking less than 12 months ago
  • History of asthma (a condition causing breathing difficulties)
  • Current lung infections or active respiratory illness other than COPD
  • Significant heart problems or cardiovascular disease
  • History of cancer within the past 5 years
  • Use of immunosuppressive medications (drugs that weaken the immune system)
  • Active or chronic infections including tuberculosis, hepatitis B, or HIV
  • Severe liver or kidney disease
  • Participation in other clinical trials within the past 30 days
  • Known allergies to study medications or their components
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Unable to perform required study procedures or follow-up visits
  • Mental conditions that could interfere with study compliance
  • Drug or alcohol abuse within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Foch Suresnes France
ASST Fatebenefratelli Sacco Milan Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Alergologia Plus Sp. z o.o. Poznan Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj Napoca Romania
Policum Berlin Studien GmbH Berlin Germany
Pneumo Studien Darmstadt GmbH Darmstadt Germany
Pro Familia Altera Sp. z o.o. Katowice Poland
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Velocity Clinical Research Luebeck GmbH Luebeck Germany
University General Hospital Of Ioannina Ioannina Greece
Ospedale S G Moscati Statte Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Ludwig Maximilian University Of Munich Munich Germany
Institutul De Pneumoftiziologie Marius Nasta Bucharest Romania
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Centre Hospitalier Universitaire De Nantes Nantes France
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Suvtyxma Cechxo Di Pkrtznerpopoctunu Cwmdpbbdw Palazu Mare Romania
Cjavizk Mznnqun Dz Dcgpracbkg Sx Tknedwfob Afaxygddv Nllsbf Snvtxc Brasov Romania
Otbhehthtxcg Czzodmn Mpxxmpye Axoy Ocvii Clanhu Kmuqxeoat Cgnmsm scve Ostrowiec Swietokrzyski Poland
Fchqiiju Cvsezkbtsxgqd Timisoara Romania
Asaumpw Sdvheywdo Lgpzod Vilyclmk Vercelli Italy
Lyxsq Gwgstom Hzarbbvx Oj Aeovkz Athens Greece
Shggxbunifbnqd Dzr mium Sfnjtaidr Peine Germany
Andpojh Ujp Tjkdosg nzlo othki Leghorn Italy
Pldifs Gmorrzst Gvoybp Mqxtqlc Kgbnitxm sovx Sosnowiec Poland
Moomdt Bmzkkev – Ddxitrvqm Wroclaw Poland
Cjdxfx Hzbxeksescc Ej Uwhslyprlntbf Ds Lduchyy Limoges France
Ele Lnpcir Lublin Poland
Cfkdek Hxrulananvv Uvrcmhklrqpwn Dg Dalqb Dijon France
Ajbwqjyagk Pgfkimto Hzcoihax Ds Mtrhyrqbx Marseille France
Zwrfoau fbn kcutgjhtv Fkffhpnab Cologne Germany
Pvlddqecbmkon Hmyfq Halle (Saale) Germany
Cjd Ctadc Rczevbovclv Lyon France
Euwn Cfovzdg Uejuh Mhkmrmpwlj Edv Śvufhro Rzeszow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
26.02.2024
Germany Germany
Not recruiting
26.02.2024
Greece Greece
Not recruiting
26.02.2024
Italy Italy
Not recruiting
26.02.2024
Poland Poland
Not recruiting
26.02.2024
Romania Romania
Not recruiting
26.02.2024

Trial locations

Tozorakimab is a medication being studied as an additional treatment for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to help reduce the frequency of COPD flare-ups (exacerbations) in people who used to smoke. The medication is given alongside standard COPD treatments to see if it can provide better control of the disease symptoms and prevent worsening of the condition.

Standard of care refers to the usual medications and treatments that COPD patients typically receive, which may include inhaled bronchodilators and corticosteroids. In this study, all participants continue their regular COPD treatments while either receiving tozorakimab or placebo.

Chronic Obstructive Pulmonary Disease (COPD) – A progressive lung condition that causes breathing difficulties due to narrowed airways and damaged lung tissue. The disease typically develops over many years, mainly affecting the bronchi and air sacs in the lungs. COPD makes it increasingly difficult to breathe, particularly during physical activity, as the airways become inflamed and thickened. The condition is characterized by persistent respiratory symptoms, including shortness of breath, chronic cough, and increased mucus production. The disease causes the lungs to gradually lose their elastic quality and become less efficient at moving air in and out.

Trial ID:
2023-503572-24-00
Protocol code:
D9180C00004
NCT ID:
NCT05158387
Trial Phase:
Therapeutic confirmatory (Phase III)

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