Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Sanofi (Voir sur ClinicalTrials)
février 2024
août 2026
30 avril 2025
ACT18018 is a multinational, randomized, double-blind, placebo-controlled,
parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to
evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared
with placebo in male and/or female participants with NCFB aged 18 years of age up to 85
years of age (inclusive).
Study details include:
- The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will
be up to 47-77 weeks.
- The treatment duration will be up to 24-52 weeks.
- The follow-up duration will be 20 weeks.
- Site/phone visits are at a monthly interval.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | BOITIAUX Jean-François | 14/02/2025 09:03:11 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Investigational Site Number : 2500001 - 69004 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500002 - 34090 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500003 - 75679 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500004 - 06001 - Nice - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500006 - 44800 - Saint-herblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participant must be 18 to 85 years of age inclusive.
- Clinical history consistent with NCFB (cough, chronic sputum production and/or
recurrent respiratory infections).
- Participants with a FEV1 % predicted ≥30%.
- Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in
the past 12 months.
- Participant must be 18 to 85 years of age inclusive.
- Clinical history consistent with NCFB (cough, chronic sputum production and/or
recurrent respiratory infections).
- Participants with a FEV1 % predicted ≥30%.
- Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in
the past 12 months.
Participants are excluded from the study if any of the following criteria apply:
- Have bronchiectasis due to CF, hypogammaglobulinemia, common variable
immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or
pulmonary fibrosis.
- Known or suspected immunodeficiency disorder.
- Pulmonary exacerbation which has not resolved clinically during screening period.
- Have significant haemoptysis.
- Have any clinically significant abnormal laboratory values at Screening or diseases
or disorders.
- History of lung transplantation.
- History of malignancy within 5 years before Screening, or during the screening
period
- Currently being treated with antimicrobial therapy for tuberculosis (TB).
- Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA).
- Participants with active autoimmune disease or participants using immunosuppressive
therapy for autoimmune disease
- Known allergy to itepekimab or to excipients
- Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive
such vaccines during the study
- Unstable ischemic heart disease
- Cardiomyopathy or other relevant cardiovascular disorder
- Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior
to, or at Screening
- History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology
at Screening.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.