AERIFY-1 (EFC16750)
Research type
Research Study
Full title
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)
IRAS ID
1008676
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2020-001818-38
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a serious and life-threatening disease. It is characterised by progressive decline in lung function and recurrent exacerbations of symptoms. The latter results in rapid disease progression and are associated with increased mortality, particularly following exacerbations that required hospitalisation. Although smoking cessation in patients with established COPD slows the rate of lung function decline and reduces the risk of hospitalisation and mortality, former smokers with COPD are still at high risk
for exacerbations and substantial morbidity and risk of mortality remain, particularly when compared to former smokers without COPD.Data from a proof-of-concept (POC) study in which Itepekimab was studied versus placebo, on top of standard of care as background therapy provided preliminary clinical evidence that Itepekimab has potential of significant benefit beyond that provided by currently available therapies to participants with moderate-to-severe COPD who are former smokers. Improvement in FEV1 (forced expiratory volume in 1 second) was also seen in former smokers, which contrasts the results in the current smoker population where minimal improvement of FEV1 was observed.
This is a double-blind, placebo-controlled, parallel group (3 groups) study design;
Study treatment groups are; 300mg Itepekimab every 2 weeks, 300mg Itepekimab every 4 weeks and matching placebo. All administered subcutaneously (SC) during a 52 week treatment period. This is followed by a 20-week safety follow-up period for all participants.This study is planned to support registration of Itepekimab in proposed COPD indication. The objective is to confirm the efficacy observed in the proof-of-concept study, assess the safety profile, and test 2 dose regimens of Itepekimab compared to placebo over 1 year, in participants with COPD who are formers smokers and are in need of additional treatment added to their current management.
REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0739
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion