Clinical trial
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
Name
ACT18018
Description
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.
Trial arms
Trial start
2024-02-20
Estimated PCD
2026-03-24
Trial end
2026-08-11
Status
Recruiting
Phase
Early phase I
Treatment
Itepekimab (SAR440340)
Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
Arms:
Itepekimab Q2W, Itepekimab Q4W
Other names:
REGN3500
Placebo
Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
Arms:
Itepekimab Q4W, Placebo
Size
300
Primary endpoint
Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period
Baseline up to End of Treatment (EOT) (24-52 weeks)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2024-05-09
1 organization
2 products
1 indication
Organization
SanofiProduct
PlaceboIndication
BronchiectasisProduct
Itepekimab