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A long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma who completed treatment period of previous amlitelimab asthma clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503385-24-00
Acronym
LTS17510
Enrollment
88
Registered
2023-08-29
Start date
2024-03-12
Completion date
Unknown
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

Percentage of participants with treatment-emergent adverse events

Detailed description

Percentage of participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs), Annualized rate of severe exacerbation events over treatment period from parent study baseline, Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline, Time to first exacerbation event from LTS17510 study baseline, Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline, Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline, Change from parent study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint, Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint, Change from parent study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint, Change from LTS17510 study baseline in pre-BD and post-BD peak expiratory flow [PEF] at each spirometry endpoint, Change from parent study baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint, Change from LTS17510 study Baseline in Pre-BD and post-BD forced vital capacity [FVC] at each spirometry endpoint, Change from parent study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint, Change from LTS17510 study baseline in pre-BD and post-BD forced expiratory flow [FEF] 25% to 75%) at each spirometry endpoint, Change from parent study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores, Change from LTS17510 study baseline in Asthma Control Questionnaire (ACQ)-5, ACQ-6, and ACQ-7 scores, Change from parent study baseline in Fractional Exhaled Nitric Oxide (FeNO), Change from LTS17510 study baseline in Fractional Exhaled Nitric Oxide (FeNO), Serum amlitelimab concentrations, Incidence of anti- amlitelimab antibody positive response, Change from parent study baseline and from LTS17510 in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score

Interventions

DRUGAmlitelimab

Sponsors

Sanofi-Aventis Recherche & Developpement
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants with treatment-emergent adverse events

Secondary

MeasureTime frame
Percentage of participants who experienced adverse events of special interest (AESI) and serious adverse events (SAEs), Annualized rate of severe exacerbation events over treatment period from parent study baseline, Annualized rate of severe exacerbation events over treatment period from LTS17510 study baseline, Time to first exacerbation event from LTS17510 study baseline, Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from parent study baseline, Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit over treatment period from LTS17510 study baseline, Change from parent study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint, Change from LTS17510 study baseline in pre bronchodilator (BD) and post-BD forced expiratory volume in 1 second (FEV1) at each spirometry endpoint, Cha

Countries

Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026