Study to evaluate the long-term safety and effectiveness of lunsekimig in adults with moderate to severe asthma

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What is this study about?

This study focuses on individuals living with asthma, a long-term condition that affects the airways in the lungs and can make breathing difficult. The research involves the use of lunsekimig, also known by the code SAR443765, which is administered via subcutaneous injection, meaning the medication is delivered through a needle just under the skin. The goal of this research is to evaluate the long-term safety and effectiveness of this treatment in adults with moderate-to-severe asthma.

Participants in this study are those who previously took part in earlier research trials. During this phase, the medication is given over an extended period to monitor how the body responds over time. This includes watching for any adverse events, which are unwanted or harmful medical occurrences, and observing the frequency of asthma exacerbations, which are sudden worsening of symptoms or attacks. The study also tracks changes in lung function and how the treatment affects daily life and breathing ease.

1 participation in the study

you will receive lunsekimig, which is an investigational medication for the treatment of asthma (a condition that affects the airways in the lungs).

the medication is administered through a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

this is an open-label extension, meaning the medication being used is known to you and the medical staff.

2 long-term monitoring

the study focuses on evaluating the long-term safety and how well the medication works over an extended period.

medical staff will monitor for any adverse events, which are any unexpected or undesirable health changes or side effects that occur during the treatment.

your asthma control and quality of life will be assessed using specific questionnaires to track changes in your symptoms and daily activities.

your lung function will be measured by checking the forced expiratory volume in 1 second, which is the amount of air you can forcefully exhale in one second.

Who Can Join the Study?

  • You must have completed a 48-week treatment period in one of two specific previous studies, known as DRI16762 or ACT18301, including the final study visit.
  • You must be using a stable amount of Inhaled Corticosteroids (ICS), which are breathing medicines used to reduce swelling in the airways, at a moderate or high dose.
  • If you were in study DRI16762, you must be taking between one and two other controller medications (daily medicines used to prevent asthma symptoms) such as LABA (long-acting bronchodilators that help open the airways), LAMA (long-acting muscarinic antagonists that also help keep airways open), LTRA (leukotriene receptor antagonists that block chemicals that cause swelling), or methylxanthines (medicines that help relax the muscles in the lungs). This may include or not include oral prednisone, which is a steroid pill used to reduce inflammation.
  • If you were in study ACT18301, you must be taking a LABA (a long-lasting medicine to open airways), either by itself or combined with an LTRA (a medicine that prevents airway swelling).
  • You must be willing and able to take part in the open-label extension study, which is a phase where all participants know which treatment they are receiving, and you must follow all scheduled visits and study tasks.
  • Female participants must not be able to become pregnant, must not be currently pregnant or breastfeeding, and must not be donating or freezing eggs.
  • Male participants must not be donating or freezing sperm.
  • You must be able to provide informed consent, which means you understand the details of the study and sign a document agreeing to participate.

Who Cannot Join the Study?

  • You cannot join if you have a new health problem or if an existing health problem has changed in a way that the doctor believes would make the study unsafe for you or prevent you from finishing the treatment.
  • You cannot join if you are an employee of the place where the study is being done, or if you are a family member of someone working on the study.
  • You cannot join if you have been diagnosed with a new pulmonary disease, which is a medical condition that affects the lungs and may make it harder for you to breathe.
  • You cannot join if you currently smoke cigarettes, use vaping products, or smoke marijuana.
  • You cannot join if you have a problem with the use of prescription drugs, illegal substances, or alcohol that the doctor considers serious.
  • You cannot join if you have a hypersensitivity or an allergy, which is an extreme immune system reaction, to the study drug or to any of the excipients, which are the inactive ingredients used to make the medicine.
  • You cannot join if you are taking any other medicines that are not allowed during this study.
  • You cannot join if you previously participated in a related study and experienced an AE or an SAE, which stands for an adverse event (an unexpected medical problem) or a serious adverse event (a medical problem that is life-threatening or results in hospitalization) that the doctor believes was caused by the study drug.
  • You cannot join if you are already taking part in any other clinical study.
  • You cannot join if you are living in an institution because of a legal or regulatory order, such as being a prisoner or being legally institutionalized.

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
Infer-Med Kft. Pecs Hungary
Hospital La Milagrosa S.A. Madrid Spain
POIS Sachsen GmbH Leipzig Germany
Erzsebet Gondozohaz Kft. Godollo Hungary
Clinica Gaias Santiago Santiago De Compostela Spain
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
Hospital Vithas Xanit Internacional Benalmadena Spain
Clinique de l’Europe Amiens France
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Universita’ Politecnica Delle Marche Ancona Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
Servei De Salut De Les Illes Balears Palma Spain
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
University Of Debrecen Debrecen Hungary
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
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
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
Oqxtkphuz Ezwmny Kxne Mosonmagyaróvár Hungary
Fhpuexxzax Stmjl Sxpf Sevilla Spain
Hgiekpiy Uaembtpubbhps Mmfhibn Dk Vazdowidtm Santander Spain
Owzmdgwzihvh Czfahnk Mmbymmok Aacr Ogoul Czoqeq Kzqhtllpt Cqoyvl sanj Ostrowiec Swietokrzyski Poland
Efydbzc Mechelen Belgium
Pjmiuz Rfqcybjwmzb Hdcrdx Svoo Barcelona Spain
Hrygsvnl Ucbhoweveddmf Rvmptlgf Ds Mqqqqn Malaga Spain
Abwyimv Umq Ikicm Do Rsdryf Eecjkf Reggio Emilia Italy
Wunkmcbcxu Snndpyk Sucz iaq sqz Ruinyg w Cgtmxqeaj Gcjgq Szrxvzcfzflbam Cojqnou Cdkund Pzlv Checiny Poland
Aptqccr Oziejmwhczz Pfim Gwuqkjtr Xwysb Bergamo Italy
Fyindueut Pplg Lc Iytytatctvcod Blwnmlirp Dow Hgazbkwl Uixlleesppjnt Ld Pxa Madrid Spain
Htxwwx Hshgercw Herlev Denmark
Hgyyonvg Unxajzcyzuujy Hkdwqedc Tnurk y Plxvqn Irwncsuk Cgwpew dpmaszkqkdelafihx (qsev Badalona Spain
Szaodnsgjbfbnf Diu Krekyq Frankfurt Germany
Kdbm Gvlb Bendorf Germany
Hamyhedy Vaie dexgzsqm Barcelona Spain
Haazjiyn Ulpsshavzidlso Slatrmnzdt &maczwn Hmhlzpz dg Hdhqymercfu STRASBOURG, Alsace France
Pufvxdfwdsmelld Evanhycpbztrj Sggkcpqsijm Irueavjfx Puspokladany Hungary

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
15.07.2026
Denmark Denmark
Not recruiting
15.07.2026
France France
Not yet recruiting
15.07.2026
Germany Germany
Not yet recruiting
15.07.2026
Hungary Hungary
Not yet recruiting
15.07.2026
Italy Italy
Not yet recruiting
15.07.2026
Poland Poland
Not yet recruiting
15.07.2026
Spain Spain
Not yet recruiting
15.07.2026
Sweden Sweden
Not yet recruiting
15.07.2026

Trial locations

Lunsekimig is a medication given as an injection under the skin to help treat asthma by targeting specific parts of the immune system to reduce inflammation.

Investigated diseases:

Asthma – This is a long-term condition that affects the airways in the lungs. It causes the tubes that carry air in and out of the lungs to become swollen and narrow. This narrowing often leads to increased mucus production. As the condition progresses, breathing can become difficult, and the airways may react more strongly to certain triggers. These reactions can cause sudden episodes of shortness of breath or coughing.

Trial ID:
2025-522896-27-00
Protocol code:
LTS17231
NCT ID:
NCT06609239
Trial Phase:
Therapeutic exploratory (Phase II)

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