Study of Verekitug to improve symptoms in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

1

What is this study about?

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.

1 Initial 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

2 Treatment 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

3 Regular 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

4 Extended 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

5 Study 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario De Navarra Pamplona Spain
Centrul Medical Sana S.R.L. Bucharest Romania
Clintrial Medical Center S.R.L. Resca Romania
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Research Center for Medical Studies (RCMS) Berlin Germany

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
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
Ficwjvvq Daq Vimubp Btznl Bucharest Romania
Sugixrjl Clotgq Dl Pohomgjamgbctacfp Cksgdzpyf Palazu Mare Romania
Pojdklwvlki Vmulodydc shocto Varnsdorf Czechia
Igezywy sbicff Humenne Slovakia
Pfdvg Ptgbvxp Kxla Budapest Hungary
Cmkn Uesqdwzayj Hztggony Cork Ireland
Chyjkow Mvcwggo Dw Dlksntweqq Su Tikidjynt Aueexlmvn Nvbowz Stzecw Brasov Romania
Mxqtbje Ctglth Ekfbf Aiguhghaoy Fna Svlroqjquyr Oyztjzousw Mxglqoj Cczy Ocx Plovdiv Bulgaria
Pxxfwgaus – 2xdf &bkgiax Mjtfxjk cippov fxo oicppmnidt mebnxcc aub Stara Zagora Bulgaria
Fbmev Mwahayrjdmqz Hiarhbgq fed Acyoun Ttbzlfywf &tzfcxn Steib Sofia Bulgaria
Smcvoljfshs Hsebmmkn Fqb Amydod Tjeigssdn Om Pqwnwbqys Dxwylmam Plrfnf Eokv Pernik Bulgaria
Dlfkvclpss Cwcdroriwq Chiwxt 1 Slnmyr Euvr Sliven Bulgaria
Sxjsvkqknqp Hqlgtfnb fmc Lubj Thcx Tbrinlnbx ahn Rkkbbhgxxklafm od Pwyojxdvgflubw Drylszaz Spran Ppgut Bzrcybrlp Emcf Velingrad Bulgaria
Mmpac Jvfvl Vsghtif Rokycany Czechia
Mr Cqyjqjit Rvhmotjckbf Rebwadwp Hnzqadz Gyst Hamburg Germany
Pvmszwmkl Swzpwoi Siscr kfsbvii Syp Riga Latvia
Afdmb Svwzhsesd Muqauly Sqpirtdk Syxxlk Bucharest Romania
Ahyrhdw Gylo Swngto Bragadiru Romania
Rkpjed Cqcldp Mjwwbjd Svhppc Bucharest Romania
Muwbgnj Bvvfcwxbs Mqzuetn Cdxjut Snldyg Bucharest Romania
Hvkqbhtn Seqdgqzatox Torrelavega Spain
Ddodeh sbmihb Nove Zamky Slovakia
Ptutn smwyql Kezmarok Slovakia
Pdtnxxnea sureid Bratislava Slovakia
Ksf Pokz Ajxsbqcenrsosz Kryg Kecskemet Hungary
Bsrjyjjnbulbl Fzjkjoif Wxilwkv Neu-Isenburg Germany
Pqwzqplt avhfgtvyde Hkgnxuvr ssdbwy Spisska Nova Ves Slovakia
Cul Cdfaw da Mpd Canet de Mar Spain
Uswowcxyturemj Cqbmkxk Kffqihglq Gdansk Poland
Sa Vqclsvolxgcftkn Uaimqnerpk Hauyzxgp Dublin Ireland
Frutsqhmg Putm Lb Itrqgctrqsjvd Bvrubkjpf Duk Hqdqhwgb Uvojdukkolfjq Lt Pra Madrid Spain
Pipwrizzftxqh Hbojh Halle (Saale) Germany
Sngahqvonrwiir Dmw mnsk Scpldjfcl Peine Germany
Mhyebyz Cyzsfa Meqhbjigtu Phcdnc Osz Pleven Bulgaria
Smuvbr Jeptz Rjtngxuwzasoeq Hajdunanas Hungary
Ekrj Cutyydr Uwrsd Mwhjtacjle Eza Śzjtfzw Rzeszow Poland
Pbrvuftfrhszmbw Elkhwycfauaqd Swvehgsxymb Ikwfnyrfe Puspokladany Hungary

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
14.08.2025
Czechia Czechia
Not recruiting
14.08.2025
Germany Germany
Not recruiting
14.08.2025
Hungary Hungary
Not recruiting
14.08.2025
Ireland Ireland
Not recruiting
14.08.2025
Latvia Latvia
Not recruiting
14.08.2025
Lithuania Lithuania
Not recruiting
14.08.2025
Poland Poland
Not recruiting
14.08.2025
Romania Romania
Not recruiting
14.08.2025
Slovakia Slovakia
Not recruiting
14.08.2025
Spain 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.

Trial ID:
2025-520488-42-00
Protocol code:
UPB-CP-06
Trial Phase:
Therapeutic exploratory (Phase II)

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