*ACT18018 Itepekimab Bronchiectasis

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, parallel-group, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

• IRAS ID

  1009268

• Contact name

  Patrick Maury

• Contact email

  pascal.minini@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche & Développement

• Eudract number

  2023-508663-70

• Research summary

  This study is taking place in approximately 20 countries. It is planned to start in February 2024. Bronchiectasis is a long-lasting lung disease characterized by the enlargement of the air passages inside the lungs due to weakening of the airway vessel wall, which leads to symptoms such as lasting shortness of breath, coughing up sputum and sometimes blood, wheezing (high pitch sound while breathing), and frequent lung infections. Available standard treatments are not always effective. In this study, researchers want to investigate if itepekimab is safe and effective in adults with bronchiectasis in addition to standard treatments they have been taking.
  Main (primary) Goal: Evaluate the efficacy of itepekimab in patients with bronchiectasis. Measurement: Rate per year of worsening of bronchiectasis. This study is a blinded study. Blinded means that neither the people taking part, nor the study doctors know who is given the study medicine or the placebo (which is a substance which looks like itepekimab but is not medically active). This is done to make sure that the study results are not influenced in any way. Treatment will last at least 24 weeks, and no longer than 52 weeks (first participants in the study will be treated for 52 weeks, the last participant to enter the study will be treated for 24 weeks). The total study duration will be up to 77 weeks. The treatment is randomly chosen for each participant meaning determined at random using a computer program. This works like flipping a coin. All participants take itepekimab or placebo (in addition to their usual medications). Itepekimab binds to a specific substance in the body that is crucial for the function of certain cells in our immune system. Itepekimab or placebo is provided as injection, given under the skin once every 2 weeks. Two different dosages of itepekimab are being tested in adults aged 18 to 85 years with bronchiectasis who require treatment in addition to their current treatment

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0369

• Date of REC Opinion

  26 Jan 2024

• REC opinion

  Further Information Favourable Opinion