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Study of lunsekimig (SAR443765) compared with placebo in adults with high-risk asthma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Asthma
Date of first enrollment	10/12/2025
Target sample size	1000
Countries of recruitment	Argentina,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Romania,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan,South Africa,Japan
Study type	Interventional
Intervention(s)	Drug: Lunsekimig (SAR443765) Pharmaceutical form: Solution for injection in vial, Route of administration: Subcutaneous (SC) injection Drug: Placebo Pharmaceutical form: Solution for injection in vial, Route of administration: SC injection Drug: Fluticasone/salmeterol Pharmaceutical form: Varies and depends on pharmaceutical presentation, Route of administration: Oral Inhalation Drug: Budesonide/formoterol Pharmaceutical form: Varies and depends on pharmaceutical presentation, Route of administration: Oral Inhalation Drug: Short-Acting Beta Agonists (SABA) Pharmaceutical form: Varies and depends on pharmaceutical presentation, Route of administration: Oral Inhalation Study Arms: - Experimental: Lunsekimig Participants will receive lunsekimig (SC injection) every 4 weeks. - - Interventions: Lunsekimig, Fluticasone/salmeterol, Budesonide/formoterol, SABA - Placebo Comparator: Placebo Participants will receive placebo (SC injection) every 4 weeks. - - Interventions: Placebo, Fluticasone/salmeterol, Budesonide/formoterol, SABA

Outcome(s)

Primary Outcome

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.

Secondary Outcome

1. Change from baseline in pre-BD FEV1 [Time Frame: From baseline to week 52] 2. Change from baseline in Asthma Control Questionnaire-5 (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 fraction of exhaled nitric oxide (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 peak expiratory flow (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 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). 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 score and in the Asthma Nighttime Symptom Diary (ANSD) daily 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]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 80age old
Gender	Both
Include criteria	- Physician-diagnosed mild-to-moderate asthma for more than 12 months based on Global Strategy for Asthma Management and Prevention (GINA) guidelines. - At least 1 asthma exacerbation in the year prior to Screening (Visit 1). - Pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) of equal or more than 40% of predicted normal (by Global Lung Function Initiative [GLI] standards) at Screening (Visit 1).
Exclude 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-Guerin (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.