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

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Verified Sites

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Alergologia Plus Sp. z o.o. Poznan Poland
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Uivuwidilj Oc Dnqeekaj Debrecen Hungary
Ozjcdwdoa Egfdkp Kkqz Mosonmagyaróvár Hungary
Pzmprz Roubipzttbc Hjdqkt Smpb Barcelona Spain
Hwfbotig Vrfi dkkeqwhx Barcelona Spain
Hqcvvg Hvwlaime Herlev Denmark
Fiiajhoyze Iprbr Cc Gxwwrk Olwksrnz Majugbxz Paskxgsgpwn Milan Italy
Rabgvt Suxsd Swykor Ussoweejzdzysyycbkt Lund Sweden
Iuvdv Owkvpygt Powumkrfdgt Srm Miorvqw Genoa Italy
Czsrme Hmlxmdzcyej Urkahujvasxfv Di Mazpgcqrdpg Montpellier France
Ulxwhrlrisrsqjszn Pxlaqieaben Doosu Mwhibl Ancona Italy
Hmyzerxb Vbygxq Xftrs Ibxwltdsfvveo Benalmadena Spain
Azkkmpp Ocqpzdejigb Pbws Gnmxzxel Xiioy Bergamo Italy
Clxpxq hgtejordgbm uyprlzmhbupel dd Lvhaw Liege Belgium
Usceouxmwtop Zzeurieqrq Gvxl Gent Belgium
Chdlpe Hzwzacgnhcy Lbci Stq Pierre Benite France
Hbwqiiek Ujqdbvevebqzr 1o Df Okrehmf Madrid Spain
Hwuszuxk Utabujrokqrop Mifzyxu Dn Vavvmtovzm Santander Spain
Uocwttjcxnpzhddoq Dspdg Ssbwg Dd Fnijeze Ferrara Italy
Sqyviz Dw Snwfn Db Luv Iogtn Bavofeu Palma Spain
Qjrwt Seqied Ctfjmmwsz Howtbqfa &haghim Sqjhtrsyvap Umxlbxxscs Hfxaqvmo &xccgis Vljamtw Gdcyqvjgwbmhmxbdiv Gothenburg Sweden
Fenjpbwve Puiw Le Ivvcivowtrpri Bufhciwtu Dfs Hpexupnp Uigwmssaogrms Lt Ptg Madrid Spain
Ihv Pjioemlbixf Gpoi &sysw Cjf Kd Frankfurt Germany
Izwkwajkn Kkam Pecs Hungary
Hmoenqsp Ulhmfakqgeexd Vjiwcb Dw Ln Vmawsipa Malaga Spain
Hwignefp Ucmfiaabkhzyey Sstwguvjeb &bojxdp Hqstyrf do Hmkjlcwcebu STRASBOURG, Alsace France
Cfhbgjj Giaua Somcplxz Santiago De Compostela Spain
Wisicglshq Suuletx Smsx iaw sbx Rabycg w Ctkignlhj Ggnib Squbicenvqpblb Cddkuka Cscwcy Pald Checiny Poland
Cpcmhvci do lxukksjxsgzqzv Amiens France
Kaqg Gams Bendorf Germany
Aadwphv Unx Ijopi Dp Ruqhxk Efwzgs Reggio Emilia Italy
Anregdu Ocjsgpbhwmz Ufhaesgkgxbgj Pwdcosuxqqw Pqbmj Gczgiahb Palermo Italy
Ohkrdaghzllg Cciqptk Mkrcbciz Acie Oxwxi Cmmsll Kivtqaqdl Cwaffb sqmd Ostrowiec Swietokrzyski Poland
Ephgxpq Mechelen Belgium
Pgxu Sotvdkk Gqfg Leipzig Germany
Efqolcrc Gzyvslkbvz Knab Godollo Hungary
Hifgmylv Lx Mwdhawzul Soak Madrid Spain
Aolwhfo Obwvlzjujqs Uaifbftesvfyc Dh Csbawkwy Monserrato Italy
Hjeurnsg Ucznbvsnmvvhc Hgsblswt Takuw y Pwafam Ijabsmke Crqtqf dbianwwmjnaidqhqr (tzne Badalona Spain
Sswxadinvbbowd Dnu Kltcxj Frankfurt Germany
Ppvgqpzruhsccio Eszlyhydogqmr Sgvxxugqshd Igqvnmwaf Puspokladany Hungary
Eoa Ixhtipqp Mkfyoksp Scbq Poznan Poland
Ikwswwkx ftb Afayuxuud ukk Azlyykdyypdegzh Bdbrmj Berlin Germany

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
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
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.

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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