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
Farkasgyepui Tudogyogyintezet
Farkasgyepu
Hungary
Medical Center Hera EOOD
Sofia
Bulgaria
Asklepios Klinik Gauting GmbH
Gauting
Germany
University Hospital Bratislava
Bratislava
Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Kaunas
Lithuania
Hospital San Pedro De Alcantara
Caceres
Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Szczecin
Poland
Bekes Varmegyei Koezponti Korhaz
Gyula
Hungary
Clinical Best Solutions Sp. z o.o. S.K.
Lublin
Poland
Rcmed Oddzial Sochaczew
Sochaczew
Poland
Hospital Quironsalud Marbella
Marbella
Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Nowa Sol
Poland
Daugavpils regionala slimnica SIA
Daugavpils
Latvia
Clinicmed Daniluk Nowak Sp. k.
Bialystok
Poland
Hospital Universitario Virgen De Las Nieves
Granada
Spain
CIMS Studienzentrum Bamberg GmbH
Bamberg
Germany
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
Poznan
Poland
Centrum Medyczne All-Med Badania Kliniczne
Cracow
Poland
Centrum Medycyny Oddechowej Mroz Sp. j.
Bialystok
Poland
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Cluj Napoca
Romania
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Ruse
Bulgaria
Pneumo Studien Darmstadt GmbH
Darmstadt
Germany
National Multidisciplinary Transport Hospital Tsar Boris III
Sofia
Bulgaria
Aranyklinika Kft.
Szeged
Hungary
Our Lady Of Lourdes Hospital
Drogheda
Ireland
IKF Pneumologie GmbH & Co. KG
Frankfurt
Germany
Infer-Med Kft.
Pecs
Hungary
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
Berlin
Germany
MECS Medical and Clinical Studies Cottbus GmbH
Cottbus
Germany
Framol-Med GmbH
Rheine
Germany
MECS Research GmbH
Berlin
Germany
Erzsebet Gondozohaz Kft.
Godollo
Hungary
Plicni Stredisko Teplice s.r.o.
Teplice
Czechia
MEDICON a.s.
Prague
Czechia
MUDr. Ilona Pavlisova s.r.o.
Miroslav
Czechia
Tallaght University Hospital
Dublin
Ireland
Diagnostics And Consultation Center Convex Ltd.
Sofia
Bulgaria
University Of Debrecen
Debrecen
Hungary
Clinexpert Kft.
Budapest
Hungary
Velocity Clinical Research Luebeck GmbH
Luebeck
Germany
Hospital Clinico Universitario De Valencia
Valencia
Spain
Medical Center Excelsior OOD
Sofia
Bulgaria
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara
Timisoara
Romania
Prvni plicni ambulance s.r.o.
Prague
Czechia
Clinmedica Research sp. z o.o.
Skierniewice
Poland
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Kaunas
Lithuania
Virgen del Rocío University Hospital
Sevilla
Spain
University Hospital Galway
Galway
Ireland
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon
Spain
Pratia S.A.
Skorzewo
Poland
Liepajas Regionala Slimnica SIA
Liepaja
Latvia
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.
Plovdiv
Bulgaria
Hospital Vithas Xanit Internacional
Benalmadena
Spain
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft
Augsburg
Germany
Koch Robert Korhaz Es Rendelointezet
Edeleny
Hungary
Veselibas centru apvieniba AS
Riga
Latvia
Respublikine Klaipedos ligonine VšĮ
Klaipeda
Lithuania
Medical Center Zdrave-1 OOD
Kozloduy
Bulgaria
Servei De Salut De Les Illes Balears
Palma
Spain
Medical Center Teodora EOOD
Ruse
Bulgaria
Edumed s.r.o.
Nachod
Czechia
Connolly Hospital
Dublin
Ireland
MUDr. I. Cierna Peterova s.r.o.
Brandys Nad Labem
Czechia
Hospital Universitario Virgen De La Victoria
Malaga
Spain
Zapa Jj s.r.o.
Levice
Slovakia
Plicni ambulance Alveolus s.r.o.
Ostrava
Czechia
Dr. Filip Shterev Individual Ambulatory Practice For Specialized Medical Care Pneumology And Phtysiatry EOOD
Plovdiv
Bulgaria
Gemeinschaftspraxis Dr. Franz & Dr. Weber
Witten
Germany
Cabinet Medical de Pneumologie Dr Mincu Bogdan
Cluj Napoca
Romania
Plicni ambulance Kralupy s.r.o.
Kralupy nad Vltavou
Czechia
Gemeinschaftspraxis Rolke und Rückert
Aschaffenburg
Germany
Pneumologische Praxis und Schlaflabor
Hanover
Germany
MEDEKA s.r.o. – Pneumologia a ftizeologia
Kosice
Slovakia
Specialized Hospital for Active Treatment of Pneumo-phthisiatric Diseases – Sofia District
Sofia
Bulgaria
Medical Center Pulmo-2018
Haskovo
Bulgaria
MHAT Sliven to MMA Sofia
Sliven
Bulgaria
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Bucharest
Romania
Sqpwdnce Csqtds Dg Phieqiuwtlxgdtuov Cskuhmvoe
Palazu Mare
Romania
Piojcavrxbp Vvpwaamjr sgjjjr
Varnsdorf
Czechia
Ifbkjry sepfxw
Humenne
Slovakia
Pfnzg Pxlekxj Kfnz
Budapest
Hungary
Cyoz Uhllxvjitp Hmhhlgrd
Cork
Ireland
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Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Bulgaria
Not recruiting
14.08.2025
Czechia
Not recruiting
14.08.2025
Germany
Not recruiting
14.08.2025
Hungary
Not recruiting
14.08.2025
Ireland
Not recruiting
14.08.2025
Latvia
Not recruiting
14.08.2025
Lithuania
Not recruiting
14.08.2025
Poland
Not recruiting
14.08.2025
Romania
Not recruiting
14.08.2025
Slovakia
Not recruiting
14.08.2025
Spain
Not recruiting
14.08.2025
Trial locations
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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