Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
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
Interventions
DRUGLunsekimig
* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: * Female participants: not pregnant or breastfeeding, and one of the following conditions applies: * Is not a women of childbearing potential (WOCBP), OR * Is a WOCBP and agrees to follow the contraceptive guidance. The WOCBP should also agree not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction. * Male participants: No sperm donation or cryopreserving sperm ICS-withdrawal sub-study only: * Participants receiving triple controller therapy (LABA+LAMA+ICS) * Participants who were compliant with lunsekimig * ≤ 1 moderate exacerbation and no severe exacerbation of COPD during the parent study * No exacerbation during the run-in period
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE) | Study baseline to Week 100 | 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. |
| 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) | From Week 12 to Week 36 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized rate of moderate-to-severe COPD exacerbations | Study baseline to Week 96 | — |
| Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1) | Parent study baseline to Weeks 48 and 96 | — |
| Change from parent study baseline in pre-BD FEV1 | Parent study baseline to Weeks 48 and 96 | — |
| Change from parent study baseline in SGRQ-C total score | Parent study baseline to Weeks 48 and 96 | 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. |
| ICS withdrawal sub-study: Time to first moderate or severe AECOPD | From Week 12 to Week 96 | AECOPD: acute exacerbation of chronic obstructive pulmonary disease |
| ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score | From Week 12 to Week 36 | 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. |
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed