Study on the Effects of Lunsekimig (SAR443765) in Adults with High-Risk Asthma Not Eligible for Biologic Treatment

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What is this study about?

This clinical trial is focused on studying asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The study is testing a new treatment called lunsekimig, also known by its code name SAR443765. This treatment is given as a solution for injection under the skin. The trial will compare the effects of lunsekimig with a placebo to see how well it works in reducing asthma flare-ups in adults who have high-risk asthma and are not currently eligible for other biologic treatments.

The purpose of the study is to evaluate how effective lunsekimig is in preventing asthma exacerbations, which are episodes where asthma symptoms become much worse. Participants in the study will receive either the lunsekimig injection or a placebo and will be monitored over a period of time to see how their asthma symptoms change. The study will also look at other factors, such as lung function, asthma control, and quality of life, to get a comprehensive understanding of the treatment’s impact.

Throughout the study, researchers will collect information on any side effects experienced by participants, as well as how the body responds to the treatment. This will help determine the safety and tolerability of lunsekimig. The study aims to provide valuable insights into whether this new treatment can offer a beneficial option for people with high-risk asthma who have limited treatment choices.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of asthma history and a lung function test to measure the forced expiratory volume in one second (FEV1).

2 randomization

Participants are randomly assigned to one of two groups: one receiving the lunsekimig (SAR443765) treatment and the other receiving a placebo. This process is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment.

3 treatment administration

The treatment involves a subcutaneous injection of either lunsekimig or placebo. The frequency and dosage are determined by the study protocol and are administered regularly throughout the trial.

4 monitoring and follow-up

Participants attend regular follow-up visits to monitor asthma symptoms, lung function, and any side effects. These visits include assessments such as the Asthma Control Questionnaire and lung function tests.

5 data collection

Data on asthma exacerbations, lung function changes, and quality of life are collected throughout the trial. This includes tracking the annualized rate of asthma exacerbation events and changes in asthma control.

6 end of trial

The trial concludes with a final assessment to evaluate the overall efficacy and safety of lunsekimig compared to placebo. Participants may be asked to provide feedback on their experience during the trial.

Who Can Join the Study?

  • You must have been diagnosed by a doctor with mild-to-moderate asthma for more than 12 months. This diagnosis should follow the GINA guidelines, which are international rules for managing asthma.
  • You should have had at least one asthma exacerbation in the year before the first screening visit. An asthma exacerbation is a worsening of asthma symptoms that may require extra treatment.
  • Your Pre-BD FEV1 should be equal to or more than 40% of what is considered normal for your age and size. Pre-BD FEV1 is a measure of how much air you can forcefully exhale in one second before using a bronchodilator, which is a medicine that helps open your airways.
  • You should be between the ages of 3 and 4 years old.
  • Both males and females can participate in the study.
  • The study includes people who may be considered vulnerable, meaning they might need extra care or protection.

Who Cannot Join the Study?

  • Individuals who do not have a diagnosis of asthma cannot participate. Asthma is a condition that affects the airways in the lungs, making it hard to breathe.
  • Participants must be within a certain age range, specifically between 18 and 65 years old.
  • Both males and females are eligible, so gender does not exclude participation.
  • People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might need special protection, like children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Alergologia Plus Sp. z o.o. Poznan Poland
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Infer-Med Kft. Pecs Hungary
Hospital La Milagrosa S.A. Madrid Spain
Erzsebet Gondozohaz Kft. Godollo Hungary
POIS Sachsen GmbH Leipzig Germany
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Medaimun GmbH Frankfurt Germany
Clinique de l’Europe Amiens France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universita’ Politecnica Delle Marche Ancona Italy
Hospital Vithas Xanit Internacional Benalmadena Spain
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
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
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
EMC Instytut Medyczny S.A. Poznan Poland
Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft. Puspokladany Hungary
Institut für Allergie und Asthmaforschung Berlin Berlin Germany
Obtfzbrlv Eeqmiw Kymu Mosonmagyaróvár Hungary
Aegljbr Cwgdtvz Studse Bucharest Romania
Hpowytiq Hrkhyssi Hvidovre Denmark
Hifyyvlq Uevvwqqhznztg Mczvxjq Dz Vcnefyvnoq Santander Spain
Ompznfslmazd Cshxkzi Mhuleezn Ayoq Oyxbr Ctlmqu Kqxztlsze Clyoky sbbr Ostrowiec Swietokrzyski Poland
Efmckfx Mechelen Belgium
Cpxhnfzqf Kvgc Hajdunanas Hungary
Pbkdgx Rmbisewklzq Hrykdb Swhp Barcelona Spain
Wnmcjddmwk Sxudtth Saag ich szl Rcecso w Czwpxjued Gwfun Svthucpsplbodi Ccgwtgi Cvgfnz Phyl Checiny Poland
Ayoowdw Uoj Ijobn Dz Raswlj Eqiamc Reggio Emilia Italy
Abjqquo Obswhqyqrqr Pwwt Gpvqkqfe Xvfqa Bergamo Italy
Fmnqxhomj Psdi Li Iezumaigbrawb Bgxeepbzw Dsp Hkeywtvc Utmuyqzrrubke La Paz Madrid Spain
Hdvhqafi Ukjylceifsoat Hmqwwesj Tmkut y Ptojgw Iagvimek Cpqkfj dyrfjcbdccworytmw (yylt Badalona Spain
Stpfewwojfszul Dqq Kygpcf Frankfurt Germany
Ktsh Gegu Bendorf Germany
Hjjtncco Vywp djrmjhbh Barcelona Spain
Hvtoxcbx Umyfvaiplitrsn Szywgwtlqr &tourrf Hrpogfb dv Hhhtmunitzu STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
04.04.2025
Denmark Denmark
Not recruiting
04.04.2025
France France
Not recruiting
04.04.2025
Germany Germany
Not recruiting
04.04.2025
Hungary Hungary
Not recruiting
04.04.2025
Italy Italy
Not recruiting
04.04.2025
Poland Poland
Not recruiting
04.04.2025
Romania Romania
Recruiting
04.04.2025
Spain Spain
Not recruiting
04.04.2025
Sweden Sweden
Not recruiting
04.04.2025

Trial locations

Investigated drugs:

Lunsekimig (SAR443765) is a medication being studied for its potential to help people with high-risk asthma. This medication is given as an injection under the skin. The trial aims to see if it can reduce asthma attacks in adults who have severe asthma but cannot currently use other biologic treatments.

Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This leads to symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity and frequency of these symptoms can vary from person to person. Asthma can be triggered by various factors, including allergens, exercise, cold air, and stress. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Managing asthma involves avoiding triggers and monitoring symptoms to prevent exacerbations.

Trial ID:
2024-513959-33-00
Protocol code:
ACT18301
NCT ID:
NCT06676319
Trial Phase:
Therapeutic exploratory (Phase II)

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