> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dose-ranging-study-of-lunsekimig-compared-with-placebo-69d49bc0-9f5f-4141-9d24-f5582d7e4e30 > Record changed: 2026-10-13 # Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma NCT06102005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Participants 685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Start date 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) Number of sites 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Title and summary **Summary** This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Acronym** AIRCULES Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Short title** Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Official title** A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Dates **Completion date** 2026-03-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **First posted** 2023-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Registry last updated** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Primary completion date** 2026-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Start date** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Size and sites **Actual participants** 685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Participants** 685 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Number of sites** 156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Identifiers **Registry ID** NCT06102005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **ClinicalTrials.gov ID** NCT06102005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Outcomes ### Primary outcomes 1. Annualized rate of asthma exacerbation events Timeframe: From baseline to week 48 ### Secondary outcomes 1. Change from baseline in pre-bronchodilator (BD) FEV1 Timeframe: From baseline to week 48 2. Change from baseline in post-BD FEV1 Timeframe: From baseline to week 48 3. The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD) Timeframe: From baseline to week 48 4. Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score Timeframe: From baseline to week 48 ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control 5. Change from baseline in ACQ-5 score Timeframe: From baseline to week 48 6. Change from baseline in FeNO Timeframe: From baseline to week 48 7. Time to first asthma exacerbation Timeframe: From baseline to week 48 8. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit Timeframe: From baseline to week 48 9. Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief Timeframe: From baseline to week 48 10. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores Timeframe: From baseline to week 48 Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. 11. Proportion of participants with ≥4-point improvement in SGRQ score Timeframe: From baseline to week 48 12. Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores Timeframe: From baseline to week 48 13. Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores Timeframe: From baseline to week 48 14. Change from baseline in ACQ scores Timeframe: From baseline to week 48 15. Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score Timeframe: From baseline to week 48 16. Serum lunsekimig concentrations Timeframe: From baseline to week 52 17. Anti-drug antibodies (ADA) against lunsekimig Timeframe: From baseline to week 52 18. Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs) Timeframe: From baseline to week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria - A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5 - Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1 - At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy - ACQ-5 score more than 1.5 at Screening (Visit 1) ### Exclusion criteria - Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease. - Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening. - Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening - Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening - For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2). - Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening - Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease - The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## Sites - Allergy, Asthma & Immunology Associates- Site Number : 8400009Scottsdale, United States - Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072Yuma, United States - Antelope Valley Clinical Trials- Site Number : 8400020Lancaster, United States - Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032Northridge, United States - Optimus Medical- Site Number : 8400046San Francisco, United States - Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038San Jose, United States - Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053Thousand Oaks, United States - Allianz Research Institute CO- Site Number : 8400026Aurora, United States - Velocity Clinical Research - Denver- Site Number : 8400027Englewood, United States - Western States Clinical Research- Site Number : 8400014Wheat Ridge, 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 - Coral Way- 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 - Advanced Research Institute - New Port Richey- Site Number : 8400044New Port Richey, United States - Pines Care Research Center- Site Number : 8400057Pembroke Pines, United States - Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019Sarasota, United States - Appalachian Clinical Research- Site Number : 8400050Calhoun, United States - PMG Research of Christie Clinic- Site Number : 8400066Champaign, United States - Velocity Clinical Research Lafayette Site Number : 8400060Lafayette, United States - Javara - Privia Medical Group - Annapolis- Site Number : 8400033Annapolis, United States - Brigham & Women's Hospital- Site Number : 8400034Boston, United States And 131 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## References - PubMed 39393433 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39393433/) Related publication ### Other registry identifiers - U1111-1280-5514 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06102005) ## 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. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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