Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
Incidence of treatment‑emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Detailed description
Functional itepekimab concentrations in serum, Incidence of treatment emergent (TE) anti-drug antibody responses, Annualized rate of moderate to severe acute exacerbation of COPD (AECOPD), Annualized rate of severe AECOPD, Time to first moderate-to-severe AECOPD, Time to first severe AECOPD, Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1, Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores, Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score, Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS, Change from Week 0 for CASA-Q
Interventions
Sponsors
Sanofi-Aventis Recherche & Developpement
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment‑emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional itepekimab concentrations in serum, Incidence of treatment emergent (TE) anti-drug antibody responses, Annualized rate of moderate to severe acute exacerbation of COPD (AECOPD), Annualized rate of severe AECOPD, Time to first moderate-to-severe AECOPD, Time to first severe AECOPD, Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1, Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores, Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score, Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS, Change from Week 0 for CASA-Q | — |
Countries
Bulgaria, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain
Outcome results
None listed