Study on Itepekimab for Former Smokers with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

This clinical trial is focused on studying Chronic Obstructive Pulmonary Disease (COPD), a condition that affects the lungs and makes it difficult to breathe. The study is testing a treatment called Itepekimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can help the immune system fight diseases. In this study, Itepekimab is being compared to a placebo to see how well it works in reducing the number of flare-ups or worsening of symptoms in people with moderate-to-severe COPD who used to smoke.

The purpose of the study is to evaluate the effectiveness, safety, and how well patients tolerate Itepekimab. Participants in the study will receive either Itepekimab or a placebo through an injection under the skin. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to find out if Itepekimab can help reduce the frequency of COPD flare-ups and improve lung function over time.

Throughout the study, researchers will also look at other aspects such as changes in breathing tests, the time it takes for the first flare-up to occur, and any side effects that may arise. This information will help determine if Itepekimab is a safe and effective treatment option for people with COPD. Participants will be closely monitored to ensure their safety and well-being throughout the study period.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the test medication, itepekimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 medication administration

The medication, itepekimab, is administered as a solution for injection using a pre-filled syringe. The route of administration is subcutaneous, which means the injection is given under the skin.

The frequency and dosage of the medication will be determined by the study protocol and communicated to the participant at the start of the trial.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the efficacy and safety of the treatment. This includes measuring the annualized rate of acute moderate or severe exacerbations of chronic obstructive pulmonary disease (COPD).

Additional assessments will include changes in lung function, specifically the forced expiratory volume in one second (FEV1), and the evaluation of respiratory symptoms using standardized questionnaires.

4 safety evaluations

Participants will be monitored for any adverse events, including treatment-emergent adverse events, serious adverse events, and any events leading to discontinuation of the treatment.

Regular laboratory tests, vital signs, and electrocardiograms (ECGs) will be conducted to ensure participant safety.

5 study completion

The study is expected to conclude by September 2025. Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment on their COPD condition.

Who Can Join the Study?

  • Participant must be between 40 and 85 years old.
  • Must have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) for at least 1 year. COPD is a lung condition that makes it hard to breathe.
  • Must have a history of smoking at least 10 pack-years. This means smoking one pack of cigarettes per day for 10 years or an equivalent amount.
  • For former smokers, they must have quit smoking at least 6 months before the start of the study and intend to quit permanently.
  • For current smokers, they must be smoking at least one cigarette per day and not planning to quit during the study period.
  • Must have moderate-to-severe COPD.
  • Must have a history of chronic bronchitis, which is a long-term cough with mucus lasting at least 3 months in the past year, and other causes of cough have been ruled out.
  • Must have a history of high risk for COPD flare-ups, defined as having at least 2 moderate or 1 severe flare-ups in the past year. A moderate flare-up is a sudden worsening of symptoms needing medication, and a severe flare-up requires hospital care.
  • Must be on a stable dose of standard COPD treatment for at least 1 month before the study. This includes medications like inhaled corticosteroids, long-acting beta-agonists, or long-acting muscarinic antagonists.
  • Must have a Body Mass Index (BMI) of at least 18.0 kg/m², or at least 16.0 kg/m² for participants from East-Asian countries. BMI is a measure of body fat based on height and weight.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for 20 weeks after the last dose of the study medication.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Hospital San Pedro De Alcantara Caceres Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital De Merida Merida Spain
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse Ruse Bulgaria
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Velocity Clinical Research Luebeck GmbH Luebeck Germany
MediTrial s.r.o. Jindřichův Hradec Czechia
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet Balassagyarmat Hungary
Giromed Institute S.L.P. Barcelona Spain
POIS Sachsen GmbH Leipzig Germany
Romed Klinikum Rosenheim Rosenheim Germany
University Teaching Hospital Markusovszky Szombathely Hungary
Saules seimos medicinos centras UAB Kaunas Lithuania
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Tartu University Hospital Tartu Estonia
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Parc Sanitari Sant Joan De Deu Sant Boi De Llobregat Spain
Klinische Forschung Berlin GbR Berlin Germany
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Allergo-Fot Kft. Szazhalombatta Hungary
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Gelre Hospitals Zutphen The Netherlands
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Leipzig Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Servei De Salut De Les Illes Balears Palma Spain
Medical Center Teodora EOOD Ruse Bulgaria
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Hospital Universitario Virgen De La Victoria Malaga Spain
Civhwa Hnokseobute Ufastkvahgmjz Rajyy Reims France
Rayegstvs Zzsbbjwdau Stqcyyscj Arnhem The Netherlands
Humohumj Ufieuqzsciydi Mmrpfbh Dp Vflhvzovhh Santander Spain
Ohawcgwitgej Cpyearu Mutyzpjt Akas Oemvp Cyejft Khwrxugcj Cttnpk shlw Ostrowiec Swietokrzyski Poland
Sbuthiwvzxx Hfrrxboc Fgf Arrwvl Tfmpqkhha Oo Psnyshrqxhcloxgjkb Difbyowb Hdfirws Eeim Haskovo Bulgaria
Sqkqmb Jnkqs Rtxhcgvmftawtp Hajdunanas Hungary
Anyqxnpu Ujuxdmdlhg Hatzvcmy Lorenskog Norway
Crpykp Hhrjtzkzdys Rmtekggy Dvpfamuagbryqm Angers France
Frrbkbczz Pibv Lg Iegknttytaihm Byyxslika Dah Hxavgmzp Uhqdpzfoxwalj Lg Pww Madrid Spain
Kidt Gcrd Bendorf Germany
Pcklqxizlwnrqcs Etenkptdjheeh Sdjfksdyjwr Ipewstlqm 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
08.04.2021
Czechia Czechia
Not recruiting
08.04.2021
Estonia Estonia
Not recruiting
08.04.2021
France France
Not recruiting
08.04.2021
Germany Germany
Not recruiting
08.04.2021
Hungary Hungary
Not recruiting
08.04.2021
Lithuania Lithuania
Not recruiting
08.04.2021
Norway Norway
Not recruiting
08.04.2021
Poland Poland
Not recruiting
08.04.2021
Portugal Portugal
Not recruiting
08.04.2021
Spain Spain
Not recruiting
08.04.2021
The Netherlands The Netherlands
Not recruiting
08.04.2021

Trial locations

Investigated drugs:

SAR440340/REGN3500/itepekimab is a medication being studied for its potential to help people with moderate-to-severe chronic obstructive pulmonary disease (COPD). It is an antibody that targets a specific protein in the body called IL-33, which is thought to play a role in inflammation. By blocking this protein, itepekimab may help reduce the number of flare-ups or worsening of symptoms in people with COPD. This study is focused on understanding how effective and safe itepekimab is for patients who have previously smoked and are dealing with this condition.

Chronic Obstructive Pulmonary Disease – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Over time, individuals with COPD may experience worsening symptoms, including increased breathlessness, frequent coughing, and mucus production. The disease can lead to episodes of exacerbations, where symptoms become more severe for a period. COPD is not fully reversible, and its progression can vary among individuals.

Trial ID:
2024-512012-21-00
Protocol code:
EFC16819
Trial Phase:
Therapeutic confirmatory (Phase III)

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