This is an open-label, Phase 3, long-term safety extension study including participants of previous lunsekimig clinical trials with inadequately controlled chronic obstructive pulmonary disease (COPD ) characterized by an eosinophilic phenotype. The purpose of the LTS 18211 study is to characterize the long-term safety and efficacy of lunsekimig in adults with COPD who completed studies EFC18243 or EFC18244 in the main study, and to assess the impact of inhaled corticosteroids (ICS ) withdrawal in the ICS withdrawal sub-study. The study duration will be up to 100 weeks, including the following components: * Baseline Visit (Visit 1 / Week 0) will coincide with the End-of-Intervention visit from the parent study (EFC18243 or EFC18244) if possible * Treatment duration of up to 96 weeks * Safety follow-up period of approximately 4 weeks * The number of visits will be 26
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,508
* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection
Newport Native MD- Site Number : 8403003
Newport Beach, California, United States
RECRUITINGHelix Biomedics- Site Number : 8403065
Boynton Beach, Florida, United States
RECRUITINGInvestigational Site Number : 8264017
Rotherham, United Kingdom
RECRUITINGExposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
Time frame: Study baseline to Week 100
ICS withdrawal sub-study: Change from Week 12 (end of run-in period) to Week 36 in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)
Time frame: From Week 12 to Week 36
Annualized rate of moderate-to-severe COPD exacerbations
Time frame: Study baseline to Week 96
Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Time frame: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in pre-BD FEV1
Time frame: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in SGRQ-C total score
The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
Time frame: Parent study baseline to Weeks 48 and 96
ICS withdrawal sub-study: Time to first moderate or severe AECOPD
AECOPD: acute exacerbation of chronic obstructive pulmonary disease
Time frame: From Week 12 to Week 96
ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score
The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
Time frame: From Week 12 to Week 36
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