A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
Purpose
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.
Condition
- Bronchiectasis
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Itepekimab Q2W |
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
|
Experimental Itepekimab Q4W |
SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks |
|
Placebo Comparator Placebo |
SC administration of matching placebo Q2W for up to 52 weeks |
|
Recruiting Locations
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com