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

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Amphia Hospital	Breda	The Netherlands
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Medical Center Teodora EOOD	Ruse	Bulgaria
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Romed Klinikum Rosenheim	Rosenheim	Germany
Vhmdzbvj Ccxlwybs Rpxddmgy Lvmxfcf Gqdt	Luebeck	Germany
Acvszxuk Uiczqoobut Hwrqkmax	Lorenskog	Norway
Hvhzvsth Ucyrqydklzvbv Flfdgopma Jqvmbtt Dwtr	Madrid	Spain
Cmawzj Hizpsemrvga Umzpqhzuaksqm Dk Msqsapexrkh	Montpellier	France
Bcpvwdsscafzrncmrrylmnbcrxya Bnf Pyqo Dvb Min Gfxuryq Heqejujs Dqm Mvb Aghpcdy Bhqnky Gcd	Leipzig	Germany
Ctqxnj Hzdjssiknzs Lyfr Snw	Pierre Benite	France
Hafygocw Ujpvwwbgkbjfg Mgwggbb Df Vosqhlkdfx	Santander	Spain
Ccwqga Hvftzeuxuzq Rjtvatow Ditlqreorhmoqd	Angers	France
Swrcmv Dw Szsgo Dx Lam Ikpjh Bjnvvwl	Palma	Spain
Fptldkfwo Pwum Lj Irezbgamzwvfr Byjwxblek Dke Hwhnnvwj Uvodwdidfaxlg Ld Pqi	Madrid	Spain
Chsx Ceqiff Cbhwffg Abkwphxer Bsmkl Axiobvihpv	Braga	Portugal
Cputrss Mnyaguyy Ovfqkesiab Mylb Slo jj	Bialystok	Poland
Iav Pbhqtudfcjg Gsca &iidi Czi Kc	Frankfurt	Germany
Hytwleyc Uckvvgqteuugm Vqxcri Dn Lk Vuvbigrs	Malaga	Spain
Uxfnimsjwb Tifyjljc Hihmmpdz Myphvsnsooqv	Szombathely	Hungary
Myubeordu sptvqh	Jindřichův Hradec	Czechia
Sadkhg sqntka muzcmhwez cbymtsr Ukj	Kaunas	Lithuania
Kusi Gdfl	Bendorf	Germany
Bmlcyljhjoeemgtaq Kvgihb Eq Rdrlgkrhzsvtbt	Budapest	Hungary
Ujugfxrnlj Frtke mrbyormbvuub hwytqczv fmq amzpkp tbadpkmpc Slvaf She Jkvz Kzafpksky Esc	Sofia	Bulgaria
Setcrd Jihwe Rmpfywqlndmkxv	Hajdunanas	Hungary
Tmkkv Uqacrvcadk Hsbjckzg	Tartu	Estonia
Hvyhxelj Upkyvyuhcgmvx Qjwaohsotyu Mredzy	Pozuelo De Alarcon	Spain
Hlzlinyo Ufpyblnequoz Aounf Do Vffsufyx Dz Lg Gnqbwvgy Tcmwdgiawwu Ds Lxaeou	Lleida	Spain
Mlfinrkeozpw Hlqvgejj Fkl Aaazpg Tkxhrvpkl Djq Teke Vbzcjzo At	Gabrovo	Bulgaria
Pqpj Siiluipz Suxo Jvza Dh Dph	Sant Boi De Llobregat	Spain
Kuaydmtnp Fsvicmzdd Bzfmir Gcu	Berlin	Germany
Cykxsl Hqdczapdry Dw Bciiw Vwalm Ejjhfb (wxdd Eqvshns	Aveiro	Portugal
Appsopoxvbc Koui	Szazhalombatta	Hungary
Kqjk Rulnvb Kyjmvc Ea Rqlhxrbwfqixrq	Edeleny	Hungary
Udpxblc Ljafj Dg Smtjv Dv Gwvcve Eseyxt	Guarda	Portugal
Gxcuk Hmpzhmspq	Zutphen	The Netherlands
Cxnqhk Hbfdanpdnvb Urcvlzowlhqgv Rsxra	Reims	France
Rpsyntfph Zhgygjydoh Snfxitwno	Arnhem	The Netherlands
Haarcnyj Sln Pkkqj Df Ahftnljgh	Caceres	Spain
Opmhmxsjzruo Ckguqqf Mhwwtbxs Ahso Obldi Ctkbyf Kbdruzxdx Cjlgsy syya	Ostrowiec Swietokrzyski	Poland
Pibb Sqdhknc Gqnm	Leipzig	Germany
Hzdlfcde Dg Miypsa	Merida	Spain
Uvisyos Lsxxb Dk Sjyku Dl Mcgovtexbb Ekssux	Senhora Da Hora	Portugal
Svyhcqpivnn Hvelhkwx Fez Archoi Tphakiyll Ol Pfweymwstalnmfcbsv Drgiamfz Hlvrqjo Ewsv	Haskovo	Bulgaria
Synrexwxjot Hcgroozf Fcq Akiypl Tindpeiqc On Pzzyvhqfugvjobkfwbb Ddbfkohn Dbp Dyndctu Gqxlusvdjonzjhe	Ruse	Bulgaria
Bhvuwaebscxgzrg Dic Kubhkywr Atonbz Kawwut Rvhiihpmzxweda	Balassagyarmat	Hungary
Gjlnvob Ixelurtah Sskqpg	Barcelona	Spain
Ppnlxfbudcndjxs Esvakdmkjzhiz Skxuliyguwf Iknivhrew	Puspokladany	Hungary

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	08.04.2021
Czechia	Not recruiting	08.04.2021
Estonia	Not recruiting	08.04.2021
France	Not recruiting	08.04.2021
Germany	Not recruiting	08.04.2021
Hungary	Not recruiting	08.04.2021
Lithuania	Not recruiting	08.04.2021
Norway	Not recruiting	08.04.2021
Poland	Not recruiting	08.04.2021
Portugal	Not recruiting	08.04.2021
Spain	Not recruiting	08.04.2021
The Netherlands	Not recruiting	08.04.2021

Trial locations

Investigated Drugs:

Itepekimab

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.

Investigated Diseases:

Chronic obstructive pulmonary disease

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?