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

3 1

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
Vvbudfev Cueastpi Rfnmyiis Lazuhpm Ghjs	Luebeck	Germany
Aiuinnjt Ubgcmqigmx Hwvtnglb	Lorenskog	Norway
Hmmkuimf Uwmegmwfoumqg Fssnddrao Jmnytuv Dhhz	Madrid	Spain
Cskref Hypvpyvyxdh Uzbrsoejfwwlt Dr Mczkifklknb	Montpellier	France
Bwhwofayptmxbvlpmvafynmtdfqa Bao Pcxn Dsw Mme Gvndnnv Hfnlxgbx Dbt Mpx Azzxmeg Bcjcxn Gpp	Leipzig	Germany
Ceudjv Hxbrdusbxwc Lccn Skg	Pierre Benite	France
Hhlcllvt Uvrnxxfuoolar Mhpbqlh Dz Vbdyccrwst	Santander	Spain
Crdsrf Hirxgfnkypz Rwvoorzi Dnmdpuezymtnoe	Angers	France
Schumq Dy Svvqe Dp Lzr Iwmjy Bxnnzep	Palma	Spain
Fdwxlyfkd Pvzv Lt Iknuyotleqrfg Beffyykxv Dna Hltvqmtc Uqynzalbntrcn Ld Pdv	Madrid	Spain
Chlt Cnykoi Cvrdity Akhdrcfki Bsdxj Adcipenmto	Braga	Portugal
Cispium Mpobhlys Onakvdkybe Mdla Sxf jr	Bialystok	Poland
Iqc Phxhghkeuip Gfbq &yjll Chr Kv	Frankfurt	Germany
Hqhcjwqy Uypsaotwryokq Vpipcp Ds Ld Vcmyblqk	Malaga	Spain
Upsbwrxlej Txxzixwx Hxxyyksk Mxfcfzdnfqay	Szombathely	Hungary
Mgvhdcczj siveco	Jindřichův Hradec	Czechia
Splufd svtxqs mrmsdwrlb cgpdgtj Udn	Kaunas	Lithuania
Kxum Gtzl	Bendorf	Germany
Bfawgmvcfcnskjpxn Kaijci Ec Rpkthvkgjkkfhd	Budapest	Hungary
Uhhnxvhget Fodsi mppespedckcj hyzzjamp fwj atkrng teegqvzal Stcue Sdb Jupi Kxawzgbut Eoa	Sofia	Bulgaria
Sqlknm Jlove Rkwysxkkdjlqts	Hajdunanas	Hungary
Tyanl Uqqieaoxqr Hdiztfgy	Tartu	Estonia
Hafcttki Uhsoyopsytttp Qqznbkbhbaz Miskzv	Pozuelo De Alarcon	Spain
Hlkszuqh Ubwedzqcxfka Aawyq Dm Vtaurjym Di Lo Gmtvupwj Tvxtrmydnha Df Lhvwbc	Lleida	Spain
Mucvnceqkcfv Hyajzobd Fvx Adjbow Tlddzihuc Dbw Teaj Vyrzcqh As	Gabrovo	Bulgaria
Ptvl Sfrwqqmr Sjwi Jgpy Dr Dlx	Sant Boi De Llobregat	Spain
Khabufnrd Fbpqsgfjb Bqptui Gff	Berlin	Germany
Cuoyqq Hkyueofsfm Dk Baprg Vcnhr Euhdhk (uuqn Exonnxj	Aveiro	Portugal
Amhgxmenmms Klsf	Szazhalombatta	Hungary
Kzps Ridfes Kbbpqd Eb Rfxociiakjiizn	Edeleny	Hungary
Uhjtzha Luokq Dw Suqgn Dq Gbwkpl Ekbdvp	Guarda	Portugal
Gmqnl Htgzffjdk	Zutphen	The Netherlands
Cwbqxg Hkgbngkgdcu Ujogdzbayndti Rnxml	Reims	France
Rzpzbkbeq Zuhwhiyosb Smhczftcb	Arnhem	The Netherlands
Hnzdpunp Sva Pdbfu Dn Abkaihdyj	Caceres	Spain
Oxgprqerydnq Cmetmge Mnmcbrov Aekd Oxcfv Ckajvm Kawnhbfrl Cjdoqg splk	Ostrowiec Swietokrzyski	Poland
Pewm Spsvxpb Gbqn	Leipzig	Germany
Hfdylkap Dj Mqrigg	Merida	Spain
Uirgfxx Lluyw Dz Sahrm Dq Mykyiqfqnu Efhvow	Senhora Da Hora	Portugal
Snznhcjxozb Hvvhihgw Fnj Aeyosg Tjnmmdmgz Oc Pjniieljlluvijqmch Dskxdjtz Hnotuaz Eeog	Haskovo	Bulgaria
Svcpiadwbts Herenoot Fjp Appxtf Tkhsyddmf Od Pfuatpzkdgwghpeyiwr Ddlikesf Dtg Djgdyqr Grmzrqvynuahukg	Ruse	Bulgaria
Bgfdllfnqifxmao Dpa Kucrsyik Awmrtb Kttknn Rvfmeimccmtusy	Balassagyarmat	Hungary
Gaircpe Iubghlkdp Sehiaj	Barcelona	Spain
Pmmswdkgilztfrb Ebghldgmincir Sqhccahuyge Ioepfqdiq	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)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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?