A Phase 2 interventional study of Lunsekimig in Asthma, sponsored by Sanofi. Enrolling by invitation at 150 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
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.
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 female participants:
For male participants:
-- No sperm donation or cryopreserving sperm
- Capable of giving signed informed consent
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Participants will receive subcutaneous injection of lunsekimig according to established dosing interval
Drug: Lunsekimig
* Pharmaceutical form: Solution for injection in vial or pre-filled syringe (PFS) * Route of administration: Subcutaneous injection
Also known as: SAR443765
Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
Time frame: From study baseline to week 148
Annualized rate of asthma exacerbation events
Time frame: From study baseline to weeks 48, 96 and 144
Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Time frame: From parent study baseline to weeks 48, 96 and 144
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score
The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Time frame: From parent study baseline to weeks 48, 96 and 144
Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score
Defined as ACQ-5 responder analysis
Time frame: From parent study baseline to weeks 48, 96 and 144
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores
The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life.
Time frame: From parent study baseline to weeks 48, 96 and 144
Serum lunsekimig concentrations
Time frame: From study baseline to week 144
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
Time frame: From study baseline to week 144
Showing the first 100 of 150 sites across 20 countries.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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