Asthma
Conditions
Brief 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.
Interventions
DRUGLunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
DRUGPlacebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of asthma exacerbation events | From baseline to week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pre-bronchodilator (BD) FEV1 | From baseline to week 48 | — |
| Change from baseline in post-BD FEV1 | From baseline to week 48 | — |
| The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD) | From baseline to week 48 | — |
| Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score | From baseline to week 48 | ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control |
| Change from baseline in ACQ-5 score | From baseline to week 48 | — |
| Change from baseline in FeNO | From baseline to week 48 | — |
| Time to first asthma exacerbation | From baseline to week 48 | — |
| Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit | From baseline to week 48 | — |
| Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief | From baseline to week 48 | — |
| Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores | 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. |
| Proportion of participants with ≥4-point improvement in SGRQ score | From baseline to week 48 | — |
| Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores | From baseline to week 48 | — |
| Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores | From baseline to week 48 | — |
| Change from baseline in ACQ scores | From baseline to week 48 | — |
| Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score | From baseline to week 48 | — |
| Serum lunsekimig concentrations | From baseline to week 52 | — |
| Anti-drug antibodies (ADA) against lunsekimig | From baseline to week 52 | — |
| 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 52 | — |
Countries
Argentina, Brazil, Canada, Chile, China, India, Israel, Japan, Mexico, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORClinial Science & Operations
Sanofi
Outcome results
None listed