The study focuses on adults who have Chronic Obstructive Pulmonary Disease that is not well‑controlled with usual medicines and who show an eosinophilic phenotype, a pattern where a type of white blood cell called eosinophils is higher than normal. Participants will receive either an injection of the experimental drug lunsekimig or a matched placebo, and neither the participants nor the study staff will know which one is given.
The purpose of the study is to see whether lunsekimig can reduce the number of moderate to severe flare‑ups of the lung disease over a year. After enrollment, participants will be randomly assigned to one of the two groups and will attend regular clinic visits for injections, safety checks, and simple breathing tests over several months.
A flare‑up, or exacerbation, means a sudden worsening of breathing problems that often requires extra medication or a hospital visit. The term Forced Expiratory Volume in 1 second refers to a common breathing test that measures how much air a person can force out of their lungs in one second; it helps doctors track lung function. The eosinophilic pattern is identified by a blood test that shows higher eosinophil counts, which can influence how the disease behaves and responds to treatment.
1randomization and assignment
after enrollment, you will be randomly assigned to receive either lunsekimig or a matched placebo that looks identical.
the assignment is double‑blind, meaning neither you nor the study staff will know which product you receive.
2first injection
you will receive an injection of the assigned product using a pre‑filled syringe.
the route is injection, and the label lists a dose of 00.00 mg; the exact amount is determined by the study protocol.
the injection is administered by trained personnel at the study site.
3subsequent injections
additional injections of the same product are given at regular intervals as specified in the study schedule.
the frequency and total number of doses are defined by the protocol and continue for the duration of the treatment period.
4clinic visits for assessments
you will attend scheduled clinic visits where several measurements are taken:
lung function tests (spirometry) before and after using a bronchodilator to measure the amount of air you can exhale in one second;
questionnaires such as the sgroq‑c, caat, and e‑rs:copd to evaluate symptoms and quality of life;
blood samples to check the concentration of lunsekimig and to test for antidrug antibodies;
routine laboratory tests to monitor safety.
5monitoring for exacerbations
during the study you will report any worsening of COPD symptoms that require medical treatment.
the study records the number and severity of moderate to severe exacerbations.
6end‑of‑treatment assessment
at the conclusion of the treatment period you will receive a final injection and undergo the same set of assessments performed at earlier visits.
data collected at this point are used to evaluate the primary and secondary outcomes of the study.
7post‑treatment safety follow‑up
after the last dose, you will be followed for a defined safety period during which additional visits or phone contacts may occur to monitor any delayed effects.
final laboratory tests and questionnaires are completed before the study ends.
Who Can Join the Study?
Be between 40 and 80 years old.
Have a doctor’s diagnosis of chronic obstructive pulmonary disease (COPD) for at least one year.
Show a lung function result called post‑bronchodilator FEV1 that is at least 20% but not more than 70% of the normal value, and a ratio of FEV1/FVC that is less than 0.70 (these numbers indicate how well the lungs can move air).
Be a former or current smoker with a history of at least 10 pack‑years (one pack‑year equals smoking one pack per day for one year).
Score 10 or higher on the Chronic Airways Assessment Test (CAAT) (a questionnaire that measures how much breathing problems affect daily life).
Have had at least two moderate or one severe COPD exacerbation (worsening of symptoms) in the past year.
Have taken triple therapy (a combination of an inhaled corticosteroid, a long‑acting beta‑agonist, and a long‑acting muscarinic antagonist) for at least 12 consecutive weeks.
Have a blood eosinophil count of 150 cells per microliter or more (eosinophils are a type of white blood cell linked to inflammation).
Have a body mass index (BMI) between 18.0 and 40.0 kg/m² (a measure of body weight relative to height).
Who Cannot Join the Study?
Having asthma (including childhood asthma) or a condition called asthma‑COPD overlap syndrome (ACOS), which means both asthma and chronic obstructive pulmonary disease are present.
Having any other serious lung disease (pulmonary disease) besides chronic obstructive pulmonary disease.
Needing long‑term oxygen support of more than 4 liters per minute, or requiring more than 2 liters per minute to keep your blood oxygen level (called oxygen saturation) above 88% while at rest.
Having an unstable medical problem that could affect your safety or the study results.
Having active tuberculosis (TB) or TB that has not been fully treated.
Having current or past cancer (malignancies).
Using certain medicines, such as long‑term macrolide antibiotics or drugs that block enzymes called phosphodiesterase‑3 (PDE‑3) or phosphodiesterase‑4 (PDE‑4), unless you have been on a stable dose for more than 6 months; also any biologic therapy (medicines made from living cells) or systemic immunosuppressant drugs taken within the last 4 months or within five drug half‑lives before screening.
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft
Augsburg
Germany
Unidade Local De Saude Do Alto Ave E.P.E.
Guimaraes
Portugal
Studienzentrum Dr. Claus Keller
Frankfurt
Germany
Semmelweis University
Budapest
Hungary
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione
LUNSEKIMIG is an investigational medicine being tested in this study. It is given as an injection using a pre‑filled syringe. The drug is designed to help adults with chronic obstructive pulmonary disease (COPD) whose symptoms are not well controlled, especially those who have an eosinophilic type of COPD. In the trial, participants receive LUNSEKIMIG to see if it can lower the number of moderate to severe COPD flare‑ups they experience over a year, while researchers also watch for safety and any side effects.
Chronic obstructive pulmonary disease – Chronic obstructive pulmonary disease (COPD) is a long‑term lung condition that causes narrowed airways and reduced airflow. It usually develops slowly and is linked to exposure to irritants such as cigarette smoke. Over time breathing becomes more difficult, with increased coughing and shortness of breath. Periodic worsening episodes, called exacerbations, can cause a sudden increase in symptoms. The disease often progresses from mild to moderate and eventually to severe limitation of breathing. Changes in lung function can be measured with tests that assess the amount of air expelled in one second.
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