AERIFY 4
Research type
Research Study
Full title
A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies
IRAS ID
1009284
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-508085-15
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.
Itepekimab is a human monoclonal antibody (a type of protein) that blocks the activity of interleukin-33 (IL33) in the body (interleukins are proteins that stimulate immune response and can cause inflammation). IL33 may play a role in COPD and blocking the effects of IL33 may improve COPD symptoms.
Itepekimab is a new drug that is being developed for treating people participants with COPD. All participants to LTS18133 will receive active drug.
Treatment is provided as liquid in a small syringe, to be injected under the skin.
The purpose of the study is to evaluate the long-term safety and tolerability of itepekimab in participants with moderate-to-severe COPD who participated in previous parent itepekimab COPD clinical studies.
Two doses of itepekimab will be tested. Participants who completed one of the parent studies and were treated with itepekimab will continue to be treated with the same dose. Participants who received placebo during the parent study could be treated with either of 2 different doses of itepekimab. For these participants, the treatment dose is randomly chosen, meaning determined by random using a computer program. This works like flipping a coin. The total treatment period will be 52 weeks and will include approximately 600-800 participants across 38 countries.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0009
Date of REC Opinion
22 Feb 2024
REC opinion
Further Information Favourable Opinion