A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07793409
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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
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Lunsekimig
(Drug)
* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection
Eligibility criteria
Conditions
Locations
- Newport Native MD- Site Number : 8403003 — Newport Beach, California, United States
- Helix Biomedics- Site Number : 8403065 — Boynton Beach, Florida, United States
- Investigational Site Number : 8264017 — Rotherham, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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