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Completed

NCT Number: NCT06102005

Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320007, Berazategui, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lunsekimig

Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Placebo

Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Primary outcomes

  1. Annualized rate of asthma exacerbation events

    Time frame: From baseline to week 48

Secondary outcomes

  1. Change from baseline in pre-bronchodilator (BD) FEV1

    Time frame: From baseline to week 48

  2. Change from baseline in post-BD FEV1

    Time frame: From baseline to week 48

  3. The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)

    Time frame: From baseline to week 48

  4. Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score

    Time frame: 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

    Time frame: From baseline to week 48

  6. Change from baseline in FeNO

    Time frame: From baseline to week 48

  7. Time to first asthma exacerbation

    Time frame: From baseline to week 48

  8. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit

    Time frame: 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

    Time frame: From baseline to week 48

  10. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores

    Time frame: 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

    Time frame: 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

    Time frame: From baseline to week 48

  13. Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores

    Time frame: From baseline to week 48

  14. Change from baseline in ACQ scores

    Time frame: From baseline to week 48

  15. Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score

    Time frame: From baseline to week 48

  16. Serum lunsekimig concentrations

    Time frame: From baseline to week 52

  17. Anti-drug antibodies (ADA) against lunsekimig

    Time frame: 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)

    Time frame: From baseline to week 52

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: AIRCULES

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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