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)
The purpose of the study is to investigate the effect, safety, and tolerability of the study drug for the treatment of patients with COPD, who continue to have symptoms on current treatment, and who are in need of an additional treatment to their current COPD management (standard of care SoC ). Simply put, we want to see if adding the drug on top of your current treatments improves COPD outcomes/exacerbations, therefore this study treatment will be given in addition to your current controller therapy.
The study is a multicentre study conducted worldwide. It will last approximately 72 weeks and will include 1170 participants, some ex-smokers, some ongoing smokers. Of those, about 740 participants will receive study drug itepekimab and about 430 participants will receive placebo (substance looks exactly like itepekimab but is not medically active). If you provide consent to participate, you will undergo study activities described in the following sections. During the study, the term “study treatment” will refer to either itepekimab or placebo.
This study is randomised, meaning study treatment will be assigned to you on a random basis (like flipping a coin). Your chance of receiving active treatment (itepekimab) if you are a former smoker at study start is 2 out of 3. Your chance of receiving active treatment (itepekimab) if you are a current smoker at study start is 1 out of 2. The study is also “blinded”, which means that both you and the study doctor will not know in which treatment group you are included and which study treatment you are receiving (itepekimab or placebo). However, in an emergency the exact treatment can be identified.