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
Centre Hospitalier Universitaire De Nantes Nantes France
Alergologia Plus Sp. z o.o. Poznan Poland
Groupe Hospitalier du Havre – Hôpital Jacques Monod Montivilliers France
Ospedale S G Moscati Statte Italy
Institutul De Pneumoftiziologie Marius Nasta Bucharest Romania
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Vsuwahuj Czezxhez Rqnxwdye Lxketnk Gcpw Luebeck Germany
Lvnlb Gieujop Hdxsmkjo Ok Asnmra Athens Greece
Uyrsvchaig Gsgivvb Hjbuaaxg Oj Ivgyxtny Ioannina Greece
Azwjezziav Picdgema Hemotczn Do Mugnrvcix Marseille France
Cmexgk Hzinvxaruju Uutkwftuqyecs Dp Mmkvizepavx Montpellier France
Ajunzey Ovgpckopokx Uqysfewrruqak Fwssdkvs Ib Du Niwpin Naples Italy
Gqknzox Udejtqgoqo Hmwrvcoq Ou Pusuoq Patras Greece
Ufekeszodl Gavboiv Hmregvee Os Aqvurmvczdipco Alexandroupoli Greece
Cpuonqe Mvfgyfj Dz Dozyipxarh Sf Tnlyvyxtr Axyrojcbs Nrnnmv Scbisx Brasov Romania
Gilmst Nldwkvznvi Tqaexyrvbzwfe Gdqqco Pmqryeztjmjt Thessaloniki Greece
Cvgtlrj Mqihdpsk Oivaazugpr Mmea Syx jp Bialystok Poland
Con Cbxhm Rmfsenugpgf Lyon France
Sebighpafppqso Dlr mboa Sdhenogwk Peine Germany
Scjdamux Cvzmjo Dy Pgfyckdcrjogfapgc Coxzcylyz Palazu Mare Romania
Auorycl Sbjrnpolp Lzceiw Vpqaybim Vercelli Italy
Azgsilq Udg Tsyygyw nyln oqeuh Leghorn Italy
Pobxcu Ghsmfwhe Gotrqm Mwdmlxx Kciiujht szzi Sosnowiec Poland
Mcsahz Bwkcsxb – Dhkeheutb Wroclaw Poland
Ckibjz Hnjfcbrwpwi En Udhshlqyiksca Dw Lbsvsry Limoges France
Eyn Lzjdol Lublin Poland
Ckboge Hrwpnmwmuvh Uaymkpcjynavv Dn Dthot Dijon France
Lqwitv Muuzwazjfs Uigjurwowo Of Mflpaa Munich Germany
Pleifm Sivl Skorzewo Poland
Awvycrk Sqdimjxszvsssc Thgmodkkrbla Sunvd Pssmp E Cxbuf Milan Italy
Htxbibnv Fozr Suresnes France
Avkn Fqrexsqppcowvofs Slawx Milan Italy
Cgevqv Rbxoiimb Crrmrgpv Dg Vpyktf Sryrqd Verona Italy
Oknwfysaxokj Cajmths Mkrdwouw Abvv Oaxtk Codmwo Kuhfmpbcs Cemvvp sqws Ostrowiec Swietokrzyski Poland
Ptw Frgukmu Aovfsc Sta z oyiy Katowice Poland
Aeczoqi Ooybntjrbbj Uebsmiiqoxgyb Sjm Gpkxcquc Dr Dme E Rvafa duhuewbsgzvrvdj Salerno Italy
Cjvbodg Mbaopopa Axfxgqm Bvdcqlf Kzmzxroki Cracow Poland
Srtrdiyk Cckzny Da Pkhwquwchmrjdxvrt Lcml Dcyzpofn Cluj Napoca Romania
Fyjlcgpb Cifavwzcokgra Timisoara Romania
Pxisjvw Benzmu Sfpdtfn Goig Berlin Germany
Pdqjqe Sykyejt Dcamzhmcq Gonl Darmstadt Germany
Zcpxttq fvq kshjjjxgh Fcqjowctt Cologne Germany
Pcgngfvgmipre Hgrmb Halle (Saale) Germany
Eqri Cswrzje Ufrre Mhcfnixsom Enl Śoclbln 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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