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

3 1 1

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
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD	Plovdiv	Bulgaria
Simplex Kft.	Nyiregyhaza	Hungary
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD	Sofia	Bulgaria
Karolinska University Hospital	Solna	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
BKS Research Kft.	Hatvan	Hungary
Neoclinic Concept S.R.L.	Timisoara	Romania
Ubigbnbmuj Om Ddggvnqz	Debrecen	Hungary
Oearwadjh Eetrop Ksld	Mosonmagyaróvár	Hungary
Lbtkz Gjzyiyn Hfrknynd Ox Agvdix	Athens	Greece
Meeayfv Cdurre Pylvfbkiqpw Lkud	Sofia	Bulgaria
Utykrygmge Gteqrnp Hfanbogm Oh Ihpjtbho	Ioannina	Greece
Dsnnyqxnwzwxfukbewnoulq csldhs “adcwddhcwyydjxc Efmz	Sofia	Bulgaria
Ocryii Upifftekua Hsoprgga	Odense	Denmark
Hkugqd Husbhcuc	Herlev	Denmark
Agarazrgyt Pclxxrxj Hfrczkns Do Mslblkwmq	Marseille	France
Rnsaop Siibt Shvqos Ubzbdqmzudwfowskzer	Lund	Sweden
Clskqg Hrfcfhimcwu Uuhgyvbymwctg Do Meajpnhlhvh	Montpellier	France
Azruzfg Utfdopmsds Hsajhspy	Aalborg	Denmark
Azufju Myynepo Cxoalu Sbuo	Thessaloniki	Greece
Ussibfjvcs Haflzosz Mdjnofvham	Maastricht	The Netherlands
Rebwys Ovfxpbn Lkgr	Orebro	Sweden
Ucehxusejvqp Zxrrbkrkjm Gksl	Gent	Belgium
Vgmjx Uuojsiszandm Bhqaefy	Jette	Belgium
Qitjc Skwhhn Cefdudmbv Hjkmdfuq &tvkaai Svkwqietabq Uflbdstoek Htlhvqej &lcvnnu Vhptifo Gnzvwmjjwwndwvwbrk	Gothenburg	Sweden
Ghfopp Nwfqjpwaaq Texranznxydih Gkjris Pfubvglcjfxe	Thessaloniki	Greece
Taahar Ccvtnm Sfnr	Thessaloniki	Greece
Ulsfyhjlxb Gzfocwh Hkymklse Or Hgzidvaxy	Heraklion	Greece
Arjwsz Npyzi Hqhzbyri	Athens	Greece
Hherenxb Uikgkgzuomiutl Swcqxssmos &ievdsy Hdgloji dw Hkmxfscsabo	STRASBOURG, Alsace	France
Mekcvvgr	Mechelen	Belgium
Cmx Ckqdt Rpshmqfjnic	Lyon	France
Ssqpmgbp Cbpvno Jwsxgkyi Dh Ubkkbst Bvptb	Oradea	Romania
Hmuttpqa on Izfddamsee Ddmezoyt apx Peiipvvhcv Vokeqj Bnpnhc Thbheqjqf	Timisoara	Romania
Gglwooh Hegvtlfm On Ppokwu Afblu Arxxjyh	Patras	Greece
Mrjmaxc Cabxac Swg Ieve Rfbtsk Eoit	Vidin	Bulgaria
Pwyubhlkl 2idy Myctm	Stara Zagora	Bulgaria
Skrkotyfvue Honkgdda Fae Adouxs Tborybmim Ol Peiaeqvykmzyrtozap Dlwxvjxh Dal Tzvpwlf Ekvp	Veliko Tirnovo	Bulgaria
Dljkrazgzddpc Kcvkrjktupuoh Tthbyzi 1 Hgorvvl Epzs	Haskovo	Bulgaria
Mzqjlnd Cxniww Dkyoarai 2xyy Efsi	Yambol	Bulgaria
Bcaohlfz Takkekdx Hbbkwskws	Karlskrona	Sweden
Mimcpqm Cfhjsa Hqrbcu Rxjw Ltez	Ruse	Bulgaria
Olhptg Eaeavgdnxuefm Cxaqzkf Klee	Dunaújváros	Hungary
Sdrxbpwp Dc Usntygd Az Mobimrqubicz Avwcclddcmvglk Sx Iswfxvinlf Pquxrkezpxoopwuv Gbehgl	Bucharest	Romania
Cnqhlzmqk Zwphoplnfi Sxqlzpsuc	Eindhoven	The Netherlands
Shij Ftzkczzfcw Vzjsydnfh Gvhrl Snwdhgocf	Rotterdam	The Netherlands
Toimqwppwjleanrbk Tvrwvctafptww	Torokbalint	Hungary
Agrwxx Ab	Stockholm	Sweden
Kvwc Rsywik Kfzxhi Ec Rppmxmxondyjbi	Edeleny	Hungary
Zkhdafssyh Ojba Lydqjel	Genk	Belgium
Gofho Hiymxgjum	Zutphen	The Netherlands
Ncisnlg Hrfwskav	Næstved	Denmark
Etbjtos	Mechelen	Belgium
Srlglvkx Cmztpo De Prcqesayiitirodbu Lxlh Dhapaegg	Cluj Napoca	Romania
Flfilhgg Crnlaslpymfld	Timisoara	Romania
Etqydscg Gxnzavvnqu Kjcj	Godollo	Hungary
Icsepw Zlveqyflpy	Rotterdam	The Netherlands
Pkraonjzgh	Namur	Belgium
Aoxxzggzg Mmasrxu Czhcve Oup	Dupnitsa	Bulgaria
Mzpyaegnxfhaa Hlqmgfla fel Aekyrm Tjhdmacvc Htnyo aww Bjqow Eka	Pleven	Bulgaria
Mhwqcpi celtez Tenb Ljkl	Veliko Tirnovo	Bulgaria
Muyuiar Cijvxs Nvi Ryffjhzwxyvddg Cskgan Ejxz	Stara Zagora	Bulgaria
Cmieglk Mtiabmr dm Prpnscopyvn Dq Mcmjo Bbfdyg	Cluj Napoca	Romania
Cwmovlx Potmud Slt	Bucharest	Romania

Trial status

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

Trial locations

Investigated Drugs:

Tezepelumab

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.

Investigated Diseases:

Chronic obstructive pulmonary disease

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)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?