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NCT Number: NCT06676319

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments.

Study details include:

* The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines.
  • At least 1 asthma exacerbation in the year prior to Screening (Visit 1).
  • Pre-BD FEV1 of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • Other severe lung diseases (eg, chronic obstructive pulmonary disease [COPD]. bronchiectasis, idiopathic pulmonary fibrosis, etc) which may impair lung function.
  • 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 (Visit 1) (counting from the date of completion of treatment for asthma exacerbation).
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening (Visit 1).
  • Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  • Evidence of any infection requiring systemic anti-infective treatment within 2 weeks before Screening (Visit 1) or during the screening period. Significant viral infections within 2 weeks before Screening (Visit 1) or during the screening period even if the participant has not received systemic antiviral treatment (eg, influenza receiving only symptomatic treatment).
  • 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 TB), or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1).
  • 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.

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical study.

Treatment and study plan

Lunsekimig

Drug

Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

Other names: SAR443765

Short-Acting Beta Agonists (SABA)

Drug

Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

Placebo

Drug

Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection

fluticasone/salmeterol

Drug

Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation

budesonide/formoterol

Drug

Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation

Budesonide/Albuterol

Drug

Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation

Primary outcomes

  1. Annualized rate of asthma exacerbation events

    Time frame: From baseline up to 52 weeks

    Asthma exacerbation event defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit due to asthma and requiring the use of systemic corticosteroids or death due to asthma

Secondary outcomes

  1. Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    Time frame: From baseline to week 52

  2. Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score

    Time frame: From baseline to week 52

    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.

  3. Change from baseline in FeNO level

    Time frame: From baseline to week 52

  4. Annualized rate of loss of asthma control events (LOAC) events

    Time frame: From baseline to week 52

    Annualized rate of LOAC events defined by 1 or more of the following criteria:

    • ≥30% reduction from baseline in morning PEF on 2 consecutive days
    • ≥6 additional reliever puffs of SABA in a 24-hour period (compared to baseline) on 2 consecutive days OR ≥4 additional puffs of low-dose budesonide/formoterol or budesonide/albuterol in a 24-hour period (compared to baseline) on 2 consecutive days
    • Worsening of asthma requiring the use of systemic corticosteroids for ≥3 days
    • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids (asthma exacerbation event)
    • Death due to asthma

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

    Time frame: From baseline to week 52

  6. Total systemic corticosteroid dose exposure

    Time frame: From baseline to week 52

  7. Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores

    Time frame: From baseline to week 52

  8. Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score

    Time frame: From baseline to week 52

  9. Serum lunsekimig concentrations

    Time frame: From baseline to week 56

  10. Incidence and titer of anti-drug antibodies (ADA) against lunsekimig

    Time frame: From baseline to week 56

  11. 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 56

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig (SAR443765) in Adult Participants With High-risk Asthma Who Are Not Currently Eligible for Biologic Treatment

Acronym: AIRLYMPUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 6, 2024
Registry last updated
Jul 1, 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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