Long-term safety of lunsekimig in adults with asthma
Tests lunsekimig under the skin in adults with asthma from earlier studies.
Plain-language title generated from the registry record
Registry title: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma
Key facts
- Where
- Goteborg, Lund, and Solna, SwedenSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with asthma who finished the treatment period of study DRI16762 or ACT18301 and want to continue with lunsekimig.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Asthma, on stable moderate or high-dose inhaled steroid (ICS) treatment together with other controller medicines, as kept during the earlier study.
- Earlier treatment
- Must have completed the treatment period of study DRI16762 or ACT18301, including the end-of-treatment visit. Stable background asthma therapy is required.
Main reasons for not taking part
- A new medical condition or treatment that, in the investigator's judgement, would affect taking part
- A new lung disease that may reduce lung function
- Current smoking or vaping of any products, or marijuana smoking
- Allergy to lunsekimig or any of its ingredients
- A side effect in the earlier study linked to lunsekimig that the investigator sees as an unreasonable risk
Read by machine on 12 November 2026.
Where in Sweden
- Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborg, SwedenNo longer taking part
- Region Skane Skanes UniversitetssjukhusLund, SwedenNo longer taking part
- Karolinska University HospitalSolna, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sanofi
- Trial code
- NCT06609239EU 2025-522896-27-00
- Record updated
- 21 September 2026
- Original description
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.Read full original descriptionShow less
An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.
The study duration will be up to 148 weeks with a treatment duration being up to 144 weeks.
Inclusion: Participants who completed the treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol; Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:; For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone; For Study ACT18301: LABA with or without LTRA; Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures; Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And:; For female participants:; incapable of becoming pregnant, or; not pregnant or breast feeding; no eggs donation or cryopreserving eggs; For male participants:; -- No sperm donation or cryopreserving sperm; Capable of giving signed informed consent.
Exclusion: Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures; Prescription drug or substance abuse, including alcohol, considered significant by the Investigator; Participants who are receiving prohibited concomitant medications; Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant; The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial; Participant who was diagnosed with a new pulmonary disease which may impair lung function; History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study; Participants are excluded from the study if any of the following criteria apply:; Current smoker or active vaping of any products and/or marijuana smoking.