A Study of Depemokimab Compared to Placebo in Adults with Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

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What is this study about?

This study is looking at Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it hard to breathe and causes repeated flare-ups where symptoms get worse. The study will test a medication called depemokimab, which is given as a solution for injection under the skin. Some people in the study will receive depemokimab while others will receive placebo. Participants may also use salbutamol sulfate as an inhalation powder when needed for breathing relief. The purpose of the study is to see how well depemokimab works compared to placebo in people with this lung disease who have a specific type of inflammation called type 2 inflammation.

The study will include adults between 40 and 80 years old who have moderate to severe lung disease with frequent flare-ups, meaning they have had at least two moderate flare-ups or one severe flare-up in the past year. Participants need to have higher levels of certain white blood cells called eosinophils in their blood. They should already be using three types of inhaled medications for their lung condition, including an inhaled steroid, for at least six months before joining the study. The study will look at how often flare-ups happen during treatment and will measure this over time.

During the study, participants will receive injections of either the study medication or placebo for up to 104 weeks. The study will measure how many flare-ups occur, how long it takes until the first flare-up happens, and how the disease affects daily life and breathing symptoms. Doctors will also track how many flare-ups require emergency room visits or hospital stays. Throughout the study, participants will continue taking their regular inhaled medications as prescribed by their doctor.

1 Initial treatment period begins

Upon joining the study, you will be randomly assigned to receive either depemokimab or placebo. Neither you nor your doctor will know which treatment you are receiving.

The treatment will be administered as an injection under the skin (subcutaneous injection). The placebo is a sterile salt water solution that contains no active medication.

You will continue taking your regular inhaled medications during the study, including your inhaled corticosteroid, long-acting muscarinic receptor antagonist, and long-acting beta2-adrenergic receptor agonist. These are medications that help keep your airways open and reduce inflammation in your lungs.

2 Rescue medication availability

Throughout the study, you will have access to salbutamol (also known as Novolizer Salbutamol) as a rescue medication.

This medication is an inhalation powder with a dose of 100 micrograms per inhalation.

You should use this medication when you experience sudden breathing difficulties or worsening of your symptoms. It works quickly to open your airways and make breathing easier.

3 Regular study visits and assessments

You will attend regular study visits where various assessments will be performed.

During these visits, your breathing function will be tested using a device that measures how much air you can breathe out and how quickly (called spirometry).

Blood samples will be taken to measure the level of certain white blood cells called eosinophils in your blood.

You will be asked to complete questionnaires about your breathing symptoms and quality of life, including the St. George’s Respiratory Questionnaire and the Evaluating Respiratory Symptoms questionnaire.

4 Monitoring at Week 52

At Week 52 (approximately one year after starting the study), specific assessments will be performed.

Your responses to the questionnaires about breathing symptoms and quality of life will be compared to your initial responses to measure any changes.

These assessments help determine how the treatment has affected your symptoms and daily functioning over the course of the year.

5 Ongoing monitoring throughout the study

Throughout the entire study period, any worsening of your condition (called exacerbations) will be recorded.

An exacerbation is when your breathing symptoms suddenly get worse and may require additional treatment, a visit to the emergency department, or hospitalization.

The study will track how often these episodes occur and how severe they are.

The total study duration is expected to continue until the end of 2029.

6 Safety monitoring

Your safety will be monitored throughout the study.

Any side effects or health changes you experience will be recorded and evaluated.

You should report any new or worsening symptoms to the study staff during your visits or as instructed.

Who Can Join the Study?

  • You must be between 40 and 80 years old when you join the study.
  • You must have an elevated blood eosinophil count, which means higher than normal levels of a specific type of white blood cell in your blood.
  • You must have moderate to severe COPD with frequent worsening episodes, which means your lung disease has been diagnosed for at least 1 year and causes regular flare-ups of symptoms.
  • Your lung function tests must show that the ratio between air you can breathe out in one second and the total air you can breathe out is less than 0.70.
  • Your lung function tests must show that you can breathe out more than 30% but no more than 80% of the air volume expected for someone of your age and size after using an inhaler medication.
  • You must have had at least 2 moderate flare-ups or 1 severe flare-up of your COPD in the past 12 months before joining the study.
  • Your COPD assessment test score must be 10 or higher at the first visit, which measures how much your lung disease affects your daily life.
  • You must be a current or former cigarette smoker who has smoked at least the equivalent of one pack of cigarettes per day for 10 years.
  • You must have been using the best available inhaler therapy for at least 6 months, which includes three types of medications: an inhaled steroid, a long-acting medication that relaxes airway muscles, and a long-acting medication that opens airways.
  • Your body mass index must be 16 or higher, which is a measure of your body weight in relation to your height.
  • You must be male or an eligible female participant.

Who Cannot Join the Study?

  • The source data does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation
  • Exclusion criteria typically include things like other medical conditions, certain medications, pregnancy status, or recent participation in other studies, but these are not specified in the available information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Hospital Vall d’Hebron Barcelona Spain
Region Sjaelland Holbæk Denmark
Centre Hospitalier Universitaire De Caen Normandie Caen France
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Herlev Hospital Herlev Denmark
Assistance Publique Hopitaux De Marseille Marseille France
Akershus University Hospital Lorenskog Norway
Helse Bergen HF Bergen Norway
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Kliniken der Stadt Koeln gGmbH Cologne Germany
Aalborg University Hospital Aalborg Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Sykehuset Oestfold HF Kalnes Graalum Norway
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
KBC Split Split Croatia
Uniwersyteckie Centrum Kliniczne Gdansk Poland
St Vincent’s University Hospital Dublin Ireland
University Of Antwerp Edegem Belgium
Universitaetsklinikum Essen AöR Essen Germany
Oncopole Claudius Regaud Toulouse France
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Marques De Valdecilla Santander Spain
Amphia Hospital Breda The Netherlands
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Az Maria Middelares Gent Gent Belgium
Vitaz Sint-Niklaas Belgium
Hospital Universitario Hm Sanchinarro Madrid Spain
Medisch Spectrum Twente Enschede The Netherlands
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Hospital Universitario Virgen De La Victoria Malaga Spain
Frisius Heerenveen The Netherlands
Connolly Hospital Dublin Ireland
University Hospital Galway Galway Ireland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Deventer Ziekenhuis Deventer The Netherlands
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Ziekenhuis Oost Limburg Genk Belgium
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Gelre Hospitals Zutphen The Netherlands
Klinikum Wuerzburg Mitte gGmbH Wuerzburg Germany
Isala Klinieken Stichting Zwolle The Netherlands
Centre Hospitalier Regional De La Citadelle Liege Belgium
Cork University Hospital Cork Ireland
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
St. Olavs Hospital HF Trondheim Norway
Emmaues Mechelen Belgium
Spaarne Gasthuis Hoofddorp The Netherlands
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
Pneumocare Namur Belgium
Hospital De Galdakao Usansolo Galdakao Spain
Hospor Hospitais Portugueses S.A. Setubal Portugal
Hospital Costa del Sol Marbella Spain

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Alergologia Plus Sp. z o.o. Poznan Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Pneumologisches Studienzentrum München-West Munich Germany
Azorg Aalst Belgium
Hbtbyrgf Vhaaqa Xosnh Ijbihpkjvpqyt Benalmadena Spain
Ajiuhiyq Zjcheqxruh Gbxzcrhtk Kortrijk Belgium
Hpkwaohm Uhnrzqnshgjaj Da Lz Rrqimc Alzira Spain
Izs Prdjitmwwnv Gwwa &ujsm Ctn Kd Frankfurt Germany
Iscaiepzy Kjjv Pecs Hungary
Sacglhezwsprgk Dhs mskg Szzylordf Peine Germany
Pjrrukmx ayjagisljg Hhhbphiz slblnn Spisska Nova Ves Slovakia
Znsunprpsl zqtywqzqpfeah Klaqrw swognn Kosice Slovakia
Ciihdu Htzzltiwpku Bdhtn Sstyrg Vifb Blois France
Mqyzdgyc Hrwbhnz Pjtut Villeurbanne France
Kzxsea Dtdhkdhori Donaustauf Germany
Ixgaiul sgzrvr Humenne Slovakia
Czabeyav db lswbyubfiojbag Amiens France
Psmetiqcluqnto Pkkuoy aj Sbedajo Cedioblwmjqjdi Berlin Germany
Pdpir Pnxndlh Kjwq Budapest Hungary
Aaffmz Aa Stockholm Sweden
Zgfpxfteepcpg Brk Bmkjq Gsjd Bad Berka Germany
Peymwkcintw Uvnesmjcys Hcwqlsfw Galway Ireland
Ptbmxdrkpxhpfxmdun Wuppertal Germany
Abyt Stpfwcbio Dg Fryslv Ferrol Spain
Hnhkxble Qsfylpqsqtr Mvhbrkno Marbella Spain
Zmsbdgoapo Si Jdoaqma Harderwijk The Netherlands
Cicolxu Mqkknvcq Ainxeyt Bwabkua Kdvygpina Cracow Poland
Utkrlwu Loezp Db Sxllr Dz Muuvmrmacn Epzpgj Senhora Da Hora Portugal
Psuqesu i Lnvt Am Lund Sweden
Prphppq Bhcvqe Syldgcz Gtzf Berlin Germany
Lvkezejo Schf Lisbon Portugal
Oww Ljht Ov Lzxbjjf Hvrpgctv Drogheda Ireland
Raylsoxd Hmfdraam Mgzatdbgn Mullingar Ireland
Pbvnbnj i Sgstcydka Ao Stockholm Sweden
Shxgzgsfxwfleu Dqr Kxanvq Frankfurt Germany
Pwzsxr Spce Ceconmj Mjygwmnl Pkihsn Bgvcmohfs Bydgoszcz Poland
Cvfsavju Hvpzkpfr Dcejwnn Zagreb Croatia
Ecdj Cexpqle Ubazq Maamifuoaf Epw Śpwakiw Rzeszow Poland
Hqsxmxuaeo Verexc Ohgtvyvuyjbky Hajdunanas Hungary
Patcshtb Ghqnbpb Leelyszh Mfhltuhhde Prqlnvkcgnak Rzeszow Poland
Nzgy Pzmiursafjj Dujwicu Bbiptak Sosnowiec Poland
Mdfbtm Bdrpskx Dpjwedqhp Wroclaw Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
31.12.2025
Croatia Croatia
Recruiting
31.12.2025
Denmark Denmark
Recruiting
31.12.2025
France France
Recruiting
31.12.2025
Germany Germany
Recruiting
31.12.2025
Hungary Hungary
Recruiting
31.12.2025
Ireland Ireland
Recruiting
31.12.2025
Norway Norway
Recruiting
31.12.2025
Poland Poland
Recruiting
31.12.2025
Portugal Portugal
Recruiting
31.12.2025
Slovakia Slovakia
Recruiting
31.12.2025
Spain Spain
Recruiting
31.12.2025
Sweden Sweden
Recruiting
31.12.2025
The Netherlands The Netherlands
Recruiting
31.12.2025

Trial locations

Depemokimab is a medication being tested in this clinical trial for people with COPD (a lung disease) who have a specific type of inflammation called Type 2 inflammation. This medicine is being studied to see if it can help improve the condition of patients with this type of COPD better than a placebo (a dummy treatment with no active medicine).

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The airways in the lungs become narrowed and damaged, which blocks airflow and makes it harder for air to move in and out. Over time, the lungs produce more mucus than normal, which further blocks the airways. People with this condition often experience shortness of breath, persistent cough, and wheezing. The disease progresses gradually, with symptoms becoming worse over the years. Periods of sudden worsening, called exacerbations, can occur when symptoms become more severe than usual.

Trial ID:
2024-520418-22-00
Protocol code:
222714
NCT ID:
NCT06959095
Trial Phase:
Therapeutic confirmatory (Phase III)

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