Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) (AERIFY-1)

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)

Detailed description

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in post-BD FEV1, Change from baseline in pre-BD FEV1, Time to first moderate or severe AECOPD, Annualized rate of severe AECOPD, Time to first severe AECOPD, Annualized rate of corticosteroid-treated AECOPD, Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score, Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope), Change from baseline in St. George’'s Respiratory Questionnaire (SGRQ) total score, Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation, Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities, Functional itepekimab concentrations in serum, Incidence of treatment-emergent anti-itepekimab antibodies responses

Related papers

No related papers found yet.

Interventions

DRUGItepekimab

DRUGMatched placebo for test product

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)	—

Secondary

Measure	Time frame
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in post-BD FEV1, Change from baseline in pre-BD FEV1, Time to first moderate or severe AECOPD, Annualized rate of severe AECOPD, Time to first severe AECOPD, Annualized rate of corticosteroid-treated AECOPD, Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score, Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope), Change from baseline in St. George’'s Respiratory Questionnaire (SGRQ) total score, Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation, Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities, Functiona	—

Measure

Time frame

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1), Change from baseline in post-BD FEV1, Change from baseline in pre-BD FEV1, Time to first moderate or severe AECOPD, Annualized rate of severe AECOPD, Time to first severe AECOPD, Annualized rate of corticosteroid-treated AECOPD, Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score, Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope), Change from baseline in St. George’'s Respiratory Questionnaire (SGRQ) total score, Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score, Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation, Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities, Functiona

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Countries

Bulgaria, Czechia, Greece, Hungary, Italy, Poland, Romania, Slovakia

Outcome results

None listed