Asthma
Conditions
Interventions
Drug: Amlitelimab
Pharmaceutical form Injection Solution, Route of administration: subcutaneous (SC) injection
Drug: Placebo
Pharmaceutical form Injection Solution, Route of administration: SC injec
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with moderate-to-severe asthma who completed the treatment period of the parent study per protocol. - Participants on background dose with medium-to-high doses of inhaled corticosteroid (ICS) therapy (>= 500 micro g of fluticasone propionate daily or comparable ICS dosage up to a maximum of 2000 micro g/day of fluticasone propionate or clinically comparable) in combination with a second or third controller (eg, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines), with or without oral corticosteroid (OCS) (up to a maximum of 15 mg prednisone or equivalent daily or 30 mg every other day) as maintained during the parent study in which they participated. Note for Japan: participants must be on >= 400 micro g of fluticasone propionate daily or equivalent. - Contraception for male and female participants; For female participants: - incapable of becoming pregnant, - not pregnant or breast feeding, - not to donate or cryopreserve eggs for female participants. For male participants: - No sperm donation or cryopreserving sperms.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Chronic lung disease other than asthma. - Participants who developed a new medical condition or a change in status of an established medical condition or require a new treatment or medication prior to enrollment, which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent investigational medicinal product discontinuation. - Current smoker or active vaping of any products and/or marijuana smoking. - Prescription drug or substance abuse, including alcohol, considered significant by the Investigator. - Any new development with the participant's disease or condition or any significant laboratory test abnormality during the parent study that, in the opinion of the Investigator, may present an unreasonable risk for the participant. - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. - Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. - Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individual.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with treatment-emergent adverse events [Time Frame: From baseline up to Week 156 (end of study [EOS] of LTS17510)] Percentage of participants with treatment emergent Adverse Events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs) [Time Frame: From baseline up to Week 156 (EOS of LTS17510)] 2. Annualized rate of severe exacerbation events over treatment period from parent study baseline [Time Frame: From baseline of the parent study up to Week 144 (end of treatment [EOT] of LTS17510)] Severe exacerbation events over treatment period from parent study baseline are defined as: Worsening of asthma requiring the use of systemic corticosteroids for >= 3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. 3. Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline [Time Frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)] Refer to the secondary outcome-2 for the definition of "severe exacerbation events". 4. Time to first exacerbation event from LTS17510 study baseline [Time Frame: From baseline of the LTE17510 study Up to Week 144 (EOT of LTS17510)] 5. Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline [Time Frame: From baseline of the parent study up to Week 144 (EOT of LTS17510)] Severe asthma exacerbations are defined as: Worsening of asthma requiring the use of systemic corticosteroids for >= 3 days (or a single IM or IV injection of corticosteroids) or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or Hospitalization or emergency room visit or urgent care visit because of asthma, requiring systemic corticosteroids. 6. Annualized rate of severe | — |
Countries
Argentina, Brazil, Canada, Chile, Hungary, Italy, Japan, Mexico, Poland, South Africa, South Korea, Turkey, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed