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

Conditions

Asthma

Brief summary

Annualized rate of asthma exacerbation events

Detailed description

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from baseline in FeNO level, Annualized rate of loss of asthma control events (LOAC) events, Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit, Total systemic corticosteroid dose exposure, Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores, Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score, Serum lunsekimig concentrations, Incidence and titer of anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment- emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized rate of asthma exacerbation events	—

Secondary

Measure	Time frame
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from baseline in FeNO level, Annualized rate of loss of asthma control events (LOAC) events, Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit, Total systemic corticosteroid dose exposure, Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores, Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score, Serum lunsekimig concentrations, Incidence and titer of anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment- emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)	—

Measure

Time frame

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score, Change from baseline in FeNO level, Annualized rate of loss of asthma control events (LOAC) events, Annualized rate of asthma exacerbations requiring hospitalization or emergency room or urgent care visit, Total systemic corticosteroid dose exposure, Change from baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ{S}) scores, Change from baseline in the Asthma Daytime Symptom Diary (ADSD) daily morning and evening score, Serum lunsekimig concentrations, Incidence and titer of anti-drug antibodies (ADA) against lunsekimig, Incidence of participants with treatment- emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)

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Countries

Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Romania, Spain, Sweden

Outcome results