This study focuses on people with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties and frequent chest infections. The study will test a new medication called Verekitug (also known as UPB-101), which is given as an injection under the skin. Some participants will receive Verekitug, while others will receive a placebo.
The main purpose of this study is to determine if Verekitug can reduce the number of COPD flare-ups (also called exacerbations) that patients experience. During these flare-ups, COPD symptoms become worse than usual, often requiring additional medical treatment. The study will involve patients who have already experienced such flare-ups in the past and are currently using standard COPD medications.
The treatment period will last for 108 weeks (approximately two years). Throughout the study, participants will receive regular injections of either Verekitug or placebo, while continuing their usual COPD medications. The study will monitor how well participants breathe, their quality of life, and any side effects they may experience. Blood samples will be taken to measure how the medication works in the body.
1Initial screening and assessment
Your doctor will check if you meet the study requirements, including age (between 40 and 85 years), diagnosis of COPD for more than 12 months, and smoking history of at least 10 pack-years
Your breathing capacity will be tested to confirm that you meet specific lung function criteria
Your current medications will be reviewed to ensure you have been using required breathing medications for at least 3 months
2Treatment period start
You will be randomly assigned to receive either Verekitug or a placebo
The medication will be given through an injection under the skin (subcutaneous injection)
You will continue using your regular breathing medications during the study
3Regular monitoring – First 60 weeks
Your lung function will be tested regularly
You will complete questionnaires about your breathing symptoms
Any breathing problems or other health issues will be recorded
Blood samples will be taken to measure medication levels in your body
4Extended monitoring – Up to 108 weeks
Continued monitoring of your COPD symptoms and any breathing difficulties
Regular checks for any side effects
Blood tests to check for antibodies to the study medication
Final assessment of how often you experienced moderate or severe breathing problems during the study
5Study completion
Final medical examination and tests
Review of your overall health and COPD status
Documentation of any remaining side effects or health concerns
Who Can Join the Study?
Must be between 40 and 85 years old when signing the consent form
Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for more than 12 months
Must be either a current smoker or former smoker with at least 10 pack-years of smoking history (pack-years = number of packs smoked per day × number of years smoking)
Must have specific lung function test results showing:
– A ratio of FEV1/FVC less than 0.70 (FEV1 is the amount of air you can forcefully exhale in one second, FVC is the total amount of air you can exhale)
– Lung function between 30% and 80% of normal predicted values
Must have significant breathlessness rated as grade 2 or higher on the Modified Medical Research Council scale
Must have experienced either:
– More than 2 moderate flare-ups or
– At least 1 severe flare-up of COPD in the past year
Must be taking triple therapy (three different types of inhaled medications: steroids, long-acting beta-agonists, and long-acting muscarinic antagonists) for at least 3 months, with a stable dose for at least 1 month before the first visit. If steroid inhalers cannot be used, taking two types of medications is acceptable
Must show at least 80% compliance with current medication for at least 4 consecutive weeks during the screening period
Who Cannot Join the Study?
History of asthma or other significant lung diseases besides COPD (chronic obstructive pulmonary disease)
Current lung infection or active respiratory illness
Major surgery within the past 3 months
Severe heart problems or uncontrolled cardiovascular disease
Current or recent cancer treatment within the past 5 years (except for certain skin cancers)
Participation in another clinical trial within the past 30 days
Allergies to medications similar to the study drug
History of severe allergic reactions to any medications
Significant kidney or liver problems
Pregnant women or women planning to become pregnant
Current drug or alcohol abuse
Unable to perform required study procedures or follow study instructions
Any condition that the study doctor believes would make participation unsafe
Taking medications that could interact with the study drug
F D Roosevelt University General Hospital Of Banska Bystrica
Banska Bystrica
Slovakia
Clinexpert Kft.
Budapest
Hungary
Centrul Medical Sana S.R.L.
Bucharest
Romania
MUDr. I. Cierna Peterova s.r.o.
Brandys Nad Labem
Czechia
Research Center for Medical Studies (RCMS)
Berlin
Germany
Pratia S.A.
Skorzewo
Poland
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft
Augsburg
Germany
Clintrial Medical Center S.R.L.
Resca
Romania
Bekes Varmegyei Koezponti Korhaz
Gyula
Hungary
Rcmed Oddzial Sochaczew
Sochaczew
Poland
Medical Center Teodora EOOD
Ruse
Bulgaria
CIMS Studienzentrum Bamberg GmbH
Bamberg
Germany
Framol-Med GmbH
Rheine
Germany
Cabinet Medical de Pneumologie Dr Mincu Bogdan
Cluj Napoca
Romania
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Sofia
Bulgaria
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Benalmadena
Spain
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Gauting
Germany
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Nachod
Czechia
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Frankfurt
Germany
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Pecs
Hungary
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Bucharest
Romania
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Hungary
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Sofia
Bulgaria
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Timisoara
Romania
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Neu-Isenburg
Germany
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Sliven
Bulgaria
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Rokycany
Czechia
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Peine
Germany
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Romania
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Bragadiru
Romania
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Slovakia
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Prague
Czechia
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Pernik
Bulgaria
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Hamburg
Germany
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Varnsdorf
Czechia
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Canet de Mar
Spain
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Poland
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Verekitug (also known as UPB-101) is an investigational medication being studied for treating moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This medication is being tested to see if it can help reduce COPD exacerbations, which are periods when COPD symptoms become worse than usual. It’s a new treatment option being evaluated to help patients who experience breathing difficulties and other COPD symptoms.
Chronic Obstructive Pulmonary Disease (COPD) – A progressive respiratory condition that makes breathing increasingly difficult over time. The disease causes the airways to become inflamed and narrowed, while also damaging the tiny air sacs (alveoli) in the lungs. The main characteristic of COPD is reduced airflow in and out of the lungs, which causes shortness of breath and other respiratory symptoms. The condition typically develops slowly over many years, with symptoms gradually becoming more noticeable and affecting daily activities. Patients may experience periods of symptom worsening called exacerbations, which can vary in severity from moderate to severe.
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