Loading clinical trials...
Loading clinical trials...
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 \[IL-33\] monoclonal antibody \[mAb\]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. * Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. * Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.
Study participation for each participant were up to a total of 46 weeks to 76 weeks including up to 10 days to 4 weeks of screening, 24-to-52 week treatment period on investigational medical product (IMP), and 20 weeks of post IMP treatment period.
Age
40 - 75 years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 8400002
Los Angeles, California, United States
Investigational Site Number 8400003
Riverside, California, United States
Investigational Site Number 8400006
Rolling Hills Estates, California, United States
Investigational Site Number 8400015
Westminster, California, United States
Investigational Site Number 8400013
Jacksonville, Florida, United States
Investigational Site Number 8400012
Columbia, Maryland, United States
Investigational Site Number 8400016
North Dartmouth, Massachusetts, United States
Investigational Site Number 8400020
South Dartmouth, Massachusetts, United States
Investigational Site Number 8400011
Minneapolis, Minnesota, United States
Investigational Site Number 8400005
Jamaica, New York, United States
Start Date
July 16, 2018
Primary Completion Date
October 3, 2019
Completion Date
February 21, 2020
Last Updated
November 22, 2022
343
ACTUAL participants
SAR440340
DRUG
Placebo
DRUG
Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
DRUG
Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
DRUG
Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
DRUG
Any short-acting β agonist as prescribed by treating physician as standard of care
DRUG
Lead Sponsor
Sanofi
Collaborators
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions