A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Conditions

Respiratory tract diseases

Brief summary

Annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations

Detailed description

Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1), Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1), Change from baseline in the SGRQ-C total score, SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score, Change from baseline in the Chronic airways assessment Test (CAAT) score, CAAT responder defined as an improvement of ≥2 points in the CAAT) total score, Change from baseline in the E-RS:COPD total score, E-RS:COPD responder defined as an improvement of ≥2 points in the E RS:COPD total score, Annualized rate of severe COPD exacerbations, Time to first moderate or severe COPD exacerbation, Time to first severe COPD exacerbation, Incidence of participants with TEAEs, including AESIs, and SAEs, Incidence of potentially clinically significant laboratory abnormalities, Serum concentration of lunsekimig, Incidence and titer of antidrug antibodies (ADAs)

Related papers

No related papers found yet.

Interventions

DRUGLUNSEKIMIG

DRUGMatched Placebo for Test

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized rate of moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations	—

Secondary

Measure	Time frame
Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1), Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1), Change from baseline in the SGRQ-C total score, SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score, Change from baseline in the Chronic airways assessment Test (CAAT) score, CAAT responder defined as an improvement of ≥2 points in the CAAT) total score, Change from baseline in the E-RS:COPD total score, E-RS:COPD responder defined as an improvement of ≥2 points in the E RS:COPD total score, Annualized rate of severe COPD exacerbations, Time to first moderate or severe COPD exacerbation, Time to first severe COPD exacerbation, Incidence of participants with TEAEs, including AESIs, and SAEs, Incidence of potentially clinically significant laboratory abnormalities, Serum concentration of lunsekimig, Incidence and titer of antidrug antibodies (ADAs)	—

Measure

Time frame

Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1), Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1), Change from baseline in the SGRQ-C total score, SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score, Change from baseline in the Chronic airways assessment Test (CAAT) score, CAAT responder defined as an improvement of ≥2 points in the CAAT) total score, Change from baseline in the E-RS:COPD total score, E-RS:COPD responder defined as an improvement of ≥2 points in the E RS:COPD total score, Annualized rate of severe COPD exacerbations, Time to first moderate or severe COPD exacerbation, Time to first severe COPD exacerbation, Incidence of participants with TEAEs, including AESIs, and SAEs, Incidence of potentially clinically significant laboratory abnormalities, Serum concentration of lunsekimig, Incidence and titer of antidrug antibodies (ADAs)

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Outcome results

None listed