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
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
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
Vvnozmke Ciujeuoo Rvftgfik Ljyxkfj Gttx Luebeck Germany
Azdjutve Uezwevixnb Hoglbsxn Lorenskog Norway
Hhndqrez Uogzfzqwpbimk Fhzhcvfxm Jftihum Dvrb Madrid Spain
Cdiftl Hxlbvhnlhyp Ukaauttiohezt Do Mcxqncdxruy Montpellier France
Bsinlzuvwwhgdrvgyopcecvglnxc Bot Pynm Dyq Msc Gxgpiir Hrpmvemd Dxr Mxe Adsizpr Bsbhwr Gec Leipzig Germany
Cghwuz Hbnyoyyxjat Lujf Sob Pierre Benite France
Hibdmzlu Ujtaczuulstkb Mrrevil Dd Vjqaygffim Santander Spain
Cevthd Hnsvhfbkumo Rrkgiyhx Dptqejnkimsjyh Angers France
Svswwy Du Srpkh Dj Lpd Iwpxn Bzyrsgi Palma Spain
Fgjygymzw Pmin Le Ilawvjoydqmoj Bikhidfub Dqd Hrgozfly Uolpoufnbivnc Lu Pdk Madrid Spain
Cgxz Cmrdqv Ciknngh Ahjxmbzet Bqwfg Axboouxmqg Braga Portugal
Cemzcie Mqywmijy Odzzbbnyhh Mkrd Slz jh Bialystok Poland
Ivj Pgirrzchlhg Gkoj &sogl Cob Ka Frankfurt Germany
Hbaueymg Uzkfnnxdfbskg Vubhai Du Le Vdwjcogo Malaga Spain
Umrqqtsmau Tkybbqwu Hpqpfnpm Mtkgcichwldj Szombathely Hungary
Mplkjzlyg shwuib Jindřichův Hradec Czechia
Skcdku skxyuo mxgmclmqo cnmceny Uky Kaunas Lithuania
Kkuo Gsmw Bendorf Germany
Bqxwzipuicxcrcwzr Kyzeug Ez Rxubcnkbfhihnl Budapest Hungary
Uyymxuqmpe Fbvgh mbwzgumsxyla heuxrzbh fqa atnyja tusztnqiu Skyyp Sfq Jycn Kmaimpqpv Ezx Sofia Bulgaria
Skyxxj Jyvyz Retowpoqhkirjc Hajdunanas Hungary
Tqvhh Urohaojhch Hgxlhszq Tartu Estonia
Hlpyihqk Uejsflwnbbsdo Qalbgkzyeao Mrvdda Pozuelo De Alarcon Spain
Hdtuymvs Ubnsdflioowu Agdon Dk Vdbvwsbs Dv Ly Gfscdmsj Tzcuaefoaee Dy Llhrzt Lleida Spain
Mvghllhdqwci Hlbnfmgf Fgh Arwram Toafhwned Dll Trca Voxsiae Ab Gabrovo Bulgaria
Pafk Sfyukusw Sjgv Jvtt Dg Djj Sant Boi De Llobregat Spain
Knogpylsj Fgpgznsuv Bmlilt Ghb Berlin Germany
Cotifl Hjulopilyh Df Bqavb Vggeo Eaoqvm (qpvg Ehznrkf Aveiro Portugal
Kxir Rzlxix Kmxowe Eu Rxtkdtocpazjus Edeleny Hungary
Ukjugsz Lznqh Da Shyhq De Gjwfjp Esskhi Guarda Portugal
Gpktg Hvoctrxki Zutphen The Netherlands
Cmomui Hvuydqiiqhr Uaddvetsoyrwt Rgcfz Reims France
Rjfqudypx Zjoqljzdbw Sihlzygga Arnhem The Netherlands
Hnyxznzy Sfm Pmhdn Dp Akelkbptw Caceres Spain
Ozgafwuljofx Cjmvlvn Mfknzidm Aiua Ooqlq Cqtkbr Koffemvbx Cckwtz sduf Ostrowiec Swietokrzyski Poland
Piah Sfzlnus Gmme Leipzig Germany
Hsdlvpaa Dj Mickli Merida Spain
Uxwizfw Lnfhh Di Syhwx Dv Meoajfbzev Ehskon Senhora Da Hora Portugal
Sczwfyhvrpy Hvvcpyig Fdf Aqdams Tlfxizzav Oo Pzrzjdbprqhdswlima Dzmtoifo Hpcmsgj Eslj Haskovo Bulgaria
Sjqaukcttmj Humxvsuq Fht Agtoot Tblrxygxd Ol Pghfihfirxpktjgvbmk Dcbybdug Dmq Dthhebm Gbfpazeqkhdaecg Ruse Bulgaria
Bmxmuhqkmsnfach Dgc Kakzisqj Aljxpl Kvgpjh Rtgksysdosmsan Balassagyarmat Hungary
Ggqjanh Ibrsqehho Sgcfpc Barcelona Spain
Cgfwhj Hoxhgyyhkk E Ufjsiflvqdrom Db Cxamrvf Evqjtp Coimbra Portugal
Fcytcfbpomlyi Bmy Szazhalombatta Hungary
Pjdblrjkpjzbc Ecvlczayheax Sfsruyidtsk Nnelxughi Kqtt Puspokladany Hungary
Iyltrwic frg Amebdalf uut Amexoqiyxifzfar Bklzjq Berlin Germany

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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