Asthma
Conditions
Brief summary
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.
Interventions
DRUGLunsekimig
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
DRUGShort-Acting Beta Agonists (SABA)
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
DRUGPlacebo
Pharmaceutical form: Solution for injection in vial; Route of administration: Subcutaneous injection
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration:Oral Inhalation
DRUGBudesonide/Formoterol
Pharmaceutical form: Varies and depends on pharmaceutical presentation; Route of administration: Oral Inhalation
DRUGBudesonide/Albuterol
Pharmaceutical form: Aerosol for inhalation; Route of administration: Oral Inhalation
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of asthma exacerbation events | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1) | From baseline to week 52 | — |
| Change from baseline in Asthma Control Questionnaire5 (ACQ-5) score | 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. |
| Change from baseline in FeNO level | From baseline to week 52 | — |
| Annualized rate of loss of asthma control events (LOAC) events | 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 |
| Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit | From baseline to week 52 | — |
| Total systemic corticosteroid dose exposure | From baseline to week 52 | — |
| Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores | From baseline to week 52 | — |
| Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score | From baseline to week 52 | — |
| Serum lunsekimig concentrations | From baseline to week 56 | — |
| Incidence and titer of anti-drug antibodies (ADA) against lunsekimig | From baseline to week 56 | — |
| Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs) | From baseline to week 56 | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed