Study on Long-Term Safety of Itepekimab for Patients with Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a treatment called itepekimab in individuals with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic lung disease that makes it difficult to breathe and can lead to coughing, wheezing, and shortness of breath. The treatment being tested, itepekimab, is a solution for injection that is administered using a pre-filled syringe. It is a type of medication known as a monoclonal antibody, which is designed to target specific proteins in the body that may contribute to inflammation and other symptoms associated with COPD.

The purpose of this study is to evaluate how safe and well-tolerated itepekimab is over a longer period in people who have already participated in previous studies involving this treatment. Participants in this study will have previously completed a treatment period in one of two earlier clinical studies. During the study, participants will receive either itepekimab or a matched placebo, which is a substance that looks like the treatment but does not contain the active ingredient. The study will monitor participants for any side effects or reactions to the treatment, as well as measure the levels of itepekimab in the blood.

Throughout the study, researchers will also observe how often participants experience flare-ups of their COPD symptoms, known as acute exacerbations, and how long it takes for these flare-ups to occur. Additionally, changes in lung function and quality of life from the baseline of the previous studies will be assessed. The study aims to provide valuable information on the long-term use of itepekimab in managing COPD symptoms and improving patient outcomes.

1 enrollment

Eligibility for the study requires completion of a previous itepekimab COPD Phase 3 clinical study, specifically EFC16750 or EFC16819.

The end-of-treatment visit from the previous study must have occurred no later than 3 days before the enrollment visit for this study.

2 initial assessment

An initial assessment is conducted to evaluate the current health status and confirm eligibility for the study.

This assessment includes reviewing medical history and any recent changes in health.

3 treatment administration

The treatment involves the administration of itepekimab, a solution for injection provided in a pre-filled syringe.

The medication is administered subcutaneously, which means it is injected under the skin.

The frequency and dosage of the medication are determined by the study protocol and are administered by healthcare professionals.

4 monitoring and follow-up

Regular monitoring is conducted to assess the long-term safety and tolerability of itepekimab.

This includes tracking any side effects or adverse events that may occur during the study period.

Follow-up visits are scheduled to evaluate the patient’s response to the treatment and to make any necessary adjustments.

5 completion of study

The study is estimated to conclude by December 1, 2026.

Upon completion, a final assessment is conducted to evaluate the overall health status and any changes observed during the study.

Who Can Join the Study?

  • Must have Chronic Obstructive Pulmonary Disease (COPD), which is a long-term lung condition that makes it hard to breathe.
  • Must have completed the treatment period in a previous study with the medicine itepekimab for COPD. This means you were part of a specific earlier study and finished the treatment there.
  • The end-of-treatment visit in the previous study must have happened no more than 3 days before joining this new study.
  • Both men and women can participate.
  • Participants should not be from a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

  • Participants who have not been part of previous studies involving the medication itepekimab for Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe.
  • Individuals who are not within the specified age range for the study. The study is looking for participants in certain age groups.
  • People who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Unidade Local De Saude De Almada-Seixal E.P.E. Almada Portugal
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Hospital San Pedro De Alcantara Caceres Spain
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Clinica Medicala Data Plus S.R.L. Bucharest Romania
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
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
MediTrial s.r.o. Jindřichův Hradec Czechia
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Medical Center Pulmo-2018 EOOD Haskovo Bulgaria
Multiprofile Hospital For Active Treatment Blagoevgrad AD Blagoevgrad Bulgaria
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
Multiprofile Hospital For Active Treatment Sveta Ekaterina-Dimitrovgrad EOOD Dimitrovgrad Bulgaria
Erzsebet Gondozohaz Kft. Godollo Hungary
Giromed Institute S.L.P. Barcelona Spain
Romed Klinikum Rosenheim Rosenheim Germany
POIS Sachsen GmbH Leipzig Germany
University Teaching Hospital Markusovszky Szombathely Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Medical Center Excelsior OOD Sofia Bulgaria
Hospital Unviersitario Miguel Servet Zaragoza Spain
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
University General Hospital Of Ioannina Ioannina Greece
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Dr. Treiman EOOD Veliko Tirnovo Bulgaria
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
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Parc Sanitari Sant Joan De Deu Sant Boi De Llobregat Spain
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.) Aveiro Portugal
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
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
Universita’ Degli Studi Di Ferrara Ferrara Italy
Servei De Salut De Les Illes Balears Palma Spain
Medical Center Teodora EOOD Ruse Bulgaria
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Hospital Universitario Virgen De La Victoria Malaga Spain
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft. Puspokladany Hungary
Institut für Allergie und Asthmaforschung Berlin Berlin Germany
University Hospital Of Montpellier Montpellier France
Zapa Jj s.r.o. Levice Slovakia
Ozgygaqgr Ezodsp Kxuy Mosonmagyaróvár Hungary
Pmlqygire 2nlm Mpetz Stara Zagora Bulgaria
Iubccgd shdgln Humenne Slovakia
Cmfcno Hmfwlolhzsc Uicjfymueryhx Rvhag Reims France
Hhadmeyu Uktjwggvgqowc Mkmtltd Db Vfvfkavwor Santander Spain
Cftpmyb Mdnthdp Do Djckqsuofa Sk Tbjdbtovo Awbgyzlia Nvtffx Sxnewg Brasov Romania
Oetovqbdnsme Chylwzq Mxcuxmno Aklh Ohuxl Cdewql Kkleblslc Csgppn smtn Ostrowiec Swietokrzyski Poland
Fbtnnptf Cscuiwlyfbxph Timisoara Romania
Myzwgfn Cktyhy Psqheevbbfb Lvba Sofia Bulgaria
Mzzjtpm Cwimgq Soy Ixkz Rvswlk Esgd Vidin Bulgaria
Cazqnhf Medtbpz di Pcjcpxhnyxm Blyusnmzyvjg Muvgp Cluj Napoca Romania
Ixqpwunlj Sbfifj Codlea Romania
Akmdlsw Geaq Sujggg Bragadiru Romania
Motjbry Cqzfbp Srfkce Deva Romania
Cyqzocaxk Kalo Hajdunanas Hungary
Pnjgnm cdodhqo sbncsr Prague Czechia
Pxheqm oxupixzw srabnm Havlickuv Brod Czechia
Purgb skjonj Presov Slovakia
Pbzsdxnf aqdxgnagal Hqjrtiyb svnkvr Spisska Nova Ves Slovakia
Aoldffxj Utwteeebcd Htbhohct Lorenskog Norway
Aidkily Obsrxpegqru Uszfvzbqgkzem Osdklrju Rlbyswk Foggia Italy
Asdyfs Mlkuhvv Cwlior Sckk Thessaloniki Greece
Czbnti Hwgyxmahggc Rbrfvvty Drvagrsozxzeji Angers France
Cpyyaj Hpvopkxqjk E Ugfwxnhrdkhrn De Censyed Efaxyy Coimbra Portugal
Sesetoda dm Pafskkctoxd Dfg Lrxeuuc Dzdazytyw Sabwp Oradea Romania
Epaokabyzrskcqtlvyckvfnxdw Hdixzefu ox Amnyny Athens Greece
Kfzb Gojx Bendorf 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
24.04.2024
Czechia Czechia
Not recruiting
24.04.2024
Denmark Denmark
Not recruiting
24.04.2024
Estonia Estonia
Not recruiting
24.04.2024
France France
Not recruiting
24.04.2024
Germany Germany
Not recruiting
24.04.2024
Greece Greece
Not recruiting
24.04.2024
Hungary Hungary
Not recruiting
24.04.2024
Italy Italy
Not recruiting
24.04.2024
Latvia Latvia
Not recruiting
24.04.2024
Lithuania Lithuania
Not recruiting
24.04.2024
Norway Norway
Not recruiting
24.04.2024
Poland Poland
Not recruiting
24.04.2024
Portugal Portugal
Not recruiting
24.04.2024
Romania Romania
Not recruiting
24.04.2024
Slovakia Slovakia
Not recruiting
24.04.2024
Spain Spain
Not recruiting
24.04.2024
The Netherlands The Netherlands
Not recruiting
24.04.2024

Trial locations

Investigated drugs:

Itepekimab is a medication being studied for its long-term safety and tolerability in patients with chronic obstructive pulmonary disease (COPD). It is intended for individuals who have already participated in previous clinical studies involving itepekimab. The goal is to understand how well patients can tolerate this medication over an extended period and to ensure it is safe for long-term use in managing COPD symptoms.

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease, commonly known as COPD, is a long-term lung condition that makes it difficult to breathe. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses slowly and is often caused by significant exposure to harmful particles or gases, most commonly from smoking. Over time, individuals with COPD may experience increased breathlessness, frequent coughing, and production of mucus. The condition can lead to episodes of worsening symptoms known as exacerbations, which can further impact lung function. COPD is a progressive disease, meaning it typically worsens over time, affecting the quality of life.

Trial ID:
2023-508085-15-00
Protocol code:
LTS18133
Trial Phase:
Therapeutic confirmatory (Phase III)

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