Study of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

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What is this study about?

This study focuses on Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The research examines the effectiveness of a medication called tezepelumab, which is given as an injection under the skin, compared to placebo in adults with moderate to very severe forms of the disease.

The main purpose of this study is to determine if tezepelumab can reduce the number of COPD flare-ups (also called exacerbations) in patients. During the study, participants will receive either tezepelumab or placebo through subcutaneous injection using a pre-filled syringe. The treatment period will last for approximately 76 weeks.

The medication being tested, tezepelumab (also known as MEDI9929), is already approved for other uses and is being studied to understand if it can help people with COPD. Throughout the study, doctors will monitor how well the treatment works and check for any side effects. Participants will need to continue using their regular COPD medications during the study period.

1 Initial screening and qualification

Your eligibility for the study will be assessed based on specific health criteria

Medical tests will be performed, including lung function tests to measure your FEV1 (amount of air you can exhale in one second)

Your medical history of COPD (chronic lung disease) will be reviewed

Blood tests will check your eosinophil level (type of white blood cell)

2 Treatment assignment

You will be randomly assigned to receive either Tezspire or a placebo (inactive substance)

Neither you nor your doctor will know which treatment you are receiving

The medication will be given as an injection under the skin (subcutaneous injection)

3 Treatment period

The study will last for 76 weeks (approximately 1.5 years)

You will receive regular injections of either Tezspire 210 mg or placebo

Your current inhaled medications for COPD will be continued as prescribed

4 Monitoring and assessments

Regular clinic visits to check your lung function

Completion of questionnaires about your symptoms and quality of life

Monitoring of any breathing problems or COPD flare-ups

Blood samples will be collected to measure drug levels and check for antibodies

Your overall health and any side effects will be monitored throughout the study

5 Final evaluation

Final assessment of your lung function and symptoms at week 76

Review of any breathing problems or COPD flare-ups during the study period

Final blood tests and health checks

Completion of final quality of life questionnaires

Who Can Join the Study?

  • Age between 40 and 80 years old at the time of signing consent
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by a doctor for at least 12 months before first visit
  • Must have specific lung function test results showing:
    – A reduced ratio of exhaled air volume (FEV1/FVC ratio less than 0.70)
    – Lung capacity between 20% and 70% of normal predicted value after using bronchodilator medication
  • Must be using prescribed inhalers regularly for at least 3 consecutive months, either:
    – Three different types combined (steroid + two types of bronchodilators), or
    – Two different types combined (any combination of steroid and bronchodilators)
  • History of either:
    – At least 2 moderate COPD flare-ups, or
    – At least 1 severe COPD flare-up in the past 12 months
    At least one moderate flare-up must have been treated with steroids
  • Must have a blood test showing eosinophil count of 150 cells or higher during screening
  • Must score 15 or higher on the COPD Assessment Test (CAT), which measures COPD symptoms
  • Must be either:
    – Current smoker, or
    – Former smoker who quit at least 6 months before first visit
    With history of smoking at least 10 pack-years (equivalent to smoking 20 cigarettes daily for 10 years)

Who Cannot Join the Study?

  • History of asthma or current diagnosis of asthma (a chronic condition that affects breathing and causes wheezing)
  • Current active lung infection or any other significant lung disease besides COPD
  • Use of immunosuppressive medications (drugs that lower the body’s immune response) within 3 months before the study
  • History of cancer within the past 5 years, except for successfully treated skin cancer
  • Serious heart conditions or uncontrolled high blood pressure
  • Liver disease or abnormal liver function tests
  • Kidney disease or significantly reduced kidney function
  • Current smokers or those who quit smoking less than 6 months ago
  • Participation in another clinical trial within the past 30 days
  • Previous treatment with tezepelumab or similar medications
  • History of severe allergic reactions to any medications
  • Pregnant women or women planning to become pregnant during the study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD Plovdiv Bulgaria
Simplex Kft. Nyiregyhaza Hungary
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
University Hospital Maastricht Maastricht The Netherlands
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Region Oerebro Laen Orebro Sweden
Universitair Ziekenhuis Gent Gent Belgium
Næstved Hospital Næstved Denmark
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
University General Hospital Of Heraklion Heraklion Greece
Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj Napoca Romania
Ikazia Ziekenhuis Rotterdam The Netherlands
Athens Naval Hospital Athens Greece
Pneumocare Namur Belgium
Asclepius Medical Center OOD Dupnitsa Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
BKS Research Kft. Hatvan Hungary
Medical center Tara Ltd. Veliko Tirnovo Bulgaria
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Thermi Clinic S.A. Thessaloniki Greece
Erzsebet Gondozohaz Kft. Godollo Hungary
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
University Of Debrecen Debrecen Hungary
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara Timisoara Romania
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
University General Hospital Of Ioannina Ioannina Greece
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD Veliko Tirnovo Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Odense University Hospital Odense Denmark
Region Skane Skanes Universitetssjukhus Lund Sweden
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Karolinska University Hospital Solna Sweden
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Centre Hospitalier Universitaire De Nantes Nantes France
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Akardo AB Stockholm Sweden
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
Ziekenhuis Oost Limburg Genk Belgium
Gelre Hospitals Zutphen The Netherlands
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Neoclinic Concept S.R.L. Timisoara Romania
Cabinet Medical de Pneumologie Dr Mincu Bogdan Cluj Napoca Romania
Clinica Pajura SRL Bucharest Romania
Mtpjyjbc Mechelen Belgium
Owwuhstkt Eihspl Ktdq Mosonmagyaróvár Hungary
Piourzyyi 2kkd Mqgcl Stara Zagora Bulgaria
Evfmdlo Mechelen Belgium
Feycuxfb Ceuilphwlewoj Timisoara Romania
Muktoxx Cayqzm Psujgkumfxg Lyfl Sofia Bulgaria
Myjxtdt Cmzkku Sfd Iqyn Rjznuo Eheo Vidin Bulgaria
Mmwdinf Chuubq Dcqcrqmc 2yvv Efde Yambol Bulgaria
Gfmefbh Hxcvinkj Ov Pyzugb Asovj Awdlhly Patras Greece
Bnjejpwc Tgzrzfzo Hezkksuqe Karlskrona Sweden
Dabsjixvjjtzm Kvrjygxiydaht Tbegowb 1 Hqewhyo Eyzr Haskovo Bulgaria
Mbewxoq Cbngrt Hzwyyt Rbfb Lnjb Ruse Bulgaria
Llnsu Gpmezoj Hcygytch Ov Asvnwf Athens Greece
Hpoowh Heyjfmpe Herlev Denmark
Amvjutepsc Pezaazdq Hhqphywk Dj Maxukctfo Marseille France
Aljveu Mbelmzl Ciimnp Stlm Thessaloniki Greece
Czx Clsfa Rgiizvfvrpv Lyon France
Hontyidc Ukzyiprqrplqfb Sdowxznrwy &kzawro Hxccwyh dv Hwhogmmsjaq STRASBOURG, Alsace France
Suvwwfkp Di Urgwanq As Mpsqrgmjuoyi Axoimxjmghjiws Sz Ihzqpkhkrf Pgttrskhbrzurfmg Giiygy Bucharest Romania

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.06.2025
Bulgaria Bulgaria
Recruiting
02.06.2025
Denmark Denmark
Recruiting
02.06.2025
France France
Recruiting
02.06.2025
Greece Greece
Recruiting
02.06.2025
Hungary Hungary
Recruiting
02.06.2025
Romania Romania
Recruiting
02.06.2025
Sweden Sweden
Recruiting
02.06.2025
The Netherlands The Netherlands
Recruiting
02.06.2025

Trial locations

Investigated drugs:

Tezepelumab is a medication being studied for treating moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It is designed to reduce the frequency and severity of COPD exacerbations (flare-ups). This medication works by targeting specific proteins in the body that are involved in airway inflammation, potentially helping patients who experience frequent worsening of their COPD symptoms.

Chronic Obstructive Pulmonary Disease (COPD) – A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The disease typically develops over many years, causing the airways to become inflamed and the air sacs in the lungs to lose their natural elasticity. People with COPD experience persistent breathing difficulties, frequent coughing, and increased mucus production. The condition often results in repeated episodes called exacerbations, where symptoms become notably worse for several days. COPD commonly affects long-term smokers and can also develop from long-term exposure to harmful air particles or gases.

Trial ID:
2024-517457-27-00
Protocol code:
JOURNEY
NCT ID:
NCT06878261
Trial Phase:
Therapeutic confirmatory (Phase III)

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