> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/long-term-safety-and-efficacy-evaluation-of-lunsekimig-30afc7ad-1480-4aa0-a738-4fa148a9d140 > Record changed: 2026-10-13 # Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma NCT06609239 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Participants 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Start date 2024-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) Number of sites 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Acronym** AIRPHRODITE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Short title** Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Dates **Completion date** 2031-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **First posted** 2024-09-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Registry last updated** 2026-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Primary completion date** 2031-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Start date** 2024-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Size and sites **Participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Planned participants** 900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Number of sites** 127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Identifiers **Registry ID** NCT06609239 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **ClinicalTrials.gov ID** NCT06609239 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Outcomes ### Primary outcomes 1. Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) Timeframe: From study baseline to week 148 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. ### Secondary outcomes 1. Annualized rate of asthma exacerbation events Timeframe: From study baseline to weeks 48, 96 and 144 2. Change from parent study baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) Timeframe: From parent study baseline to weeks 48, 96 and 144 3. Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score Timeframe: From parent study baseline to weeks 48, 96 and 144 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. 4. Proportion of participants with ≥0.5-point reduction in each ACQ-5 score as compared to parent study baseline score Timeframe: From parent study baseline to weeks 48, 96 and 144 Defined as ACQ-5 responder analysis 5. 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 Timeframe: From parent study baseline to weeks 48, 96 and 144 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. 6. Serum lunsekimig concentrations Timeframe: From study baseline to week 144 7. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig Timeframe: From study baseline to week 144 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria Participants are excluded from the study if any of the following criteria apply: - 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 - Participant who was diagnosed with a new pulmonary disease which may impair lung function - Current smoker or active vaping of any products and/or marijuana smoking - Prescription drug or substance abuse, including alcohol, considered significant by the Investigator - 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 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Sites - Chandler Clinical Research Trials- Site Number : 8400075Chandler, United States - Tucson Clinical Research Institute- Site Number : 8400085Tucson, United States - Allianz Research Institute - Aurora- Site Number : 8400026Aurora, United States - Western States Clinical Research- Site Number : 8400014Wheat Ridge, United States - Helix Biomedics- Site Number : 8400114Boynton Beach, United States - Beautiful Minds Clinical Research Center- Site Number : 8400049Cutler Bay, United States - Qway Research - Hialeah- Site Number : 8400015Hialeah, United States - Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048Miami, United States - High Quality Research- Site Number : 8400039Miami, United States - Innovations Biotech- Site Number : 8400040Miami, United States - New Access Medical Center- Site Number : 8400043Miami, United States - Deluxe Health Center- Site Number : 8400045Miami Lakes, United States - Tellabio International Research Services- Site Number : 8400083Pembroke Pines, United States - Avanza Medical Research Center- Site Number : 8400135Pensacola, United States - Ilumina Medical Research- Site Number : 8400095Saint Cloud, United States - Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019Sarasota, United States - Brigham & Women's Hospital- Site Number : 8400034Boston, United States - University of Michigan Health System - Ann Arbor- Site Number : 8400004Ann Arbor, United States - Midwest Clinical Research Center - St. Louis- Site Number : 8400006St Louis, United States - Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029Charlotte, United States - Asthma & Allergy Center - Toledo- Site Number : 8400017Toledo, United States - OK Clinical Research- Site Number : 8400021Edmond, United States - Clinical Research Associates of Central Pennsylvania- Site Number : 8400116DuBois, United States - Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007Pittsburgh, United States - Orion Clinical Research- Site Number : 8400001Austin, United States And 102 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## References - Related resource (euclinicaltrials.eu) Source: [euclinicaltrials.eu](https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-522896-27-00) ### Other registry identifiers (3) - 2025 - 2025-522896-27 - U1111-1303-3645 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06609239) ## Related records ### Drugs (1) - [Lunsekimig](https://trialight.com/data/asset/lunsekimig-87cedd43-e3f5-4dac-9250-3a13afbe6402.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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