Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1). To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1. To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
The total duration of the study (per participant) was approximately 36 weeks, including 4 weeks screening, 12 weeks treatment, and 20 weeks post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
296
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled
Pharmaceutical form: Solution for Injection, Route of administration: SC
Pharmaceutical form: Solution for Injection, Route of administration: SC
Investigational Site Number 8400026
Birmingham, Alabama, United States
Investigational Site Number 8400004
Long Beach, California, United States
Investigational Site Number 8400020
Los Angeles, California, United States
Investigational Site Number 8400001
Rolling Hills Estates, California, United States
Investigational Site Number 8400013
San Jose, California, United States
Percentage of Participants With Loss of Asthma Control
An LOAC event during the 12-week treatment period was a deterioration of asthma defined as any of the following: a) 30 percent (%) or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; b) greater than or equal to (\>=) 6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; c) increase in inhaled corticosteroid (ICS) \>=4 times the last prescribed ICS dose (or \>=50% of the prescribed ICS dose at Baseline if background therapy withdrawal completed); d) required use of systemic (oral and/or parenteral) steroid treatment; e) required hospitalization or emergency room visit.
Time frame: From Baseline up to Week 12
Change From Baseline at Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Pre-bronchodilator FEV1 refers to the spirometry performed after a wash period of bronchodilators (i.e., not earlier than 6 hours) after the last dose of albuterol/salbutamol or levalbuterol/levosalbutamol from a primed meter dose inhaler and withholding the last dose of long-acting β2 adrenergic agonist (LABA) for at least 12 hours, and prior to administration of study drug.
Time frame: Baseline, Week 12
Change From Baseline at Week 12 in Post-bronchodilator Forced Expiratory Volume in 1 Second
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 refers to the spirometry performed within 30 minutes after administration of bronchodilator.
Time frame: Baseline, Week 12
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Investigational Site Number 8400009
Stockton, California, United States
Investigational Site Number 8400016
Colorado Springs, Colorado, United States
Investigational Site Number 8400021
Ann Arbor, Michigan, United States
Investigational Site Number 8400022
Minneapolis, Minnesota, United States
Investigational Site Number 8400007
Papillion, Nebraska, United States
...and 61 more locations