Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
- Conditions
- Asthma
- Interventions
- Drug: Placebo for SAR440340Drug: Placebo for dupilumab
- Registration Number
- NCT03387852
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
The total duration of the study (per participant) was approximately 36 weeks, including 4 weeks screening, 12 weeks treatment, and 20 weeks post-treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 296
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab Placebo for SAR440340 Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks. SAR440340 + Dupilumab Fluticasone or Fluticasone/salmeterol combination Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks. SAR440340 SAR440340 Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks. SAR440340 Fluticasone or Fluticasone/salmeterol combination Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks. Dupilumab Fluticasone or Fluticasone/salmeterol combination Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks. Placebo Fluticasone or Fluticasone/salmeterol combination Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks. Placebo Placebo for dupilumab Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks. SAR440340 Placebo for dupilumab Participants received 2 injections of SAR440340 300 milligram (mg) along with 1 injection of dupilumab placebo, subcutaneous (SC) once every 2 weeks (Q2W) for 12 weeks. Placebo Placebo for SAR440340 Participants received 2 SC injections of SAR440340 placebo along with 1 SC injection of dupilumab placebo Q2W for 12 weeks. SAR440340 + Dupilumab SAR440340 Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks. Dupilumab Dupilumab Participants received 1 injection of dupilumab 300 mg along with 2 injections of SAR440340 placebo, SC Q2W for 12 weeks. SAR440340 + Dupilumab Dupilumab Participants received 2 injections of SAR440340 300 mg along with 1 injection of dupilumab 300 mg, SC Q2W for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Loss of Asthma Control From Baseline up to Week 12 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline at Week 12 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Baseline, Week 12 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.
Change From Baseline at Week 12 in Post-bronchodilator Forced Expiratory Volume in 1 Second Baseline, Week 12 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.
Trial Locations
- Locations (71)
Investigational Site Number 4840004
🇲🇽Durango, Mexico
Investigational Site Number 8400014
🇺🇸Milwaukee, Wisconsin, United States
Investigational Site Number 8400021
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number 0320003
🇦🇷Caba, Argentina
Investigational Site Number 0320005
🇦🇷Mendoza, Argentina
Investigational Site Number 0320002
🇦🇷Caba, Argentina
Investigational Site Number 0320004
🇦🇷Caba, Argentina
Investigational Site Number 1520002
🇨🇱Quillota, Chile
Investigational Site Number 1520001
🇨🇱Santiago, Chile
Investigational Site Number 1520009
🇨🇱Santiago, Chile
Investigational Site Number 1520004
🇨🇱Santiago, Chile
Investigational Site Number 1520005
🇨🇱Talca, Chile
Investigational Site Number 4840005
🇲🇽Chihuahua, Mexico
Investigational Site Number 1520008
🇨🇱Santiago, Chile
Investigational Site Number 1520007
🇨🇱Santiago, Chile
Investigational Site Number 4840003
🇲🇽Veracruz, Mexico
Investigational Site Number 6160001
🇵🇱Bialystok, Poland
Investigational Site Number 6160008
🇵🇱Bialystok, Poland
Investigational Site Number 6160005
🇵🇱Bydgoszcz, Poland
Investigational Site Number 7920003
🇹🇷Bursa, Turkey
Investigational Site Number 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number 6160002
🇵🇱Poznan, Poland
Investigational Site Number 6160006
🇵🇱Poznan, Poland
Investigational Site Number 6160003
🇵🇱Znin, Poland
Investigational Site Number 6430008
🇷🇺Ryazan, Russian Federation
Investigational Site Number 6430003
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430005
🇷🇺Moscow, Russian Federation
Investigational Site Number 6430010
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6430006
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 6430007
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 6430009
🇷🇺Stavropol, Russian Federation
Investigational Site Number 6430004
🇷🇺Ulyanovsk, Russian Federation
Investigational Site Number 7920006
🇹🇷Izmir, Turkey
Investigational Site Number 7920007
🇹🇷Izmir, Turkey
Investigational Site Number 7920004
🇹🇷Ankara, Turkey
Investigational Site Number 7920001
🇹🇷Istanbul, Turkey
Investigational Site Number 7920008
🇹🇷Kirikkale, Turkey
Investigational Site Number 8040001
🇺🇦Kyiv, Ukraine
Investigational Site Number 8040005
🇺🇦Vinnytsya, Ukraine
Investigational Site Number 7920002
🇹🇷Mersin, Turkey
Investigational Site Number 7920009
🇹🇷Rize, Turkey
Investigational Site Number 8040008
🇺🇦Chernivtsi, Ukraine
Investigational Site Number 8040002
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8040011
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8400008
🇺🇸Murray, Utah, United States
Investigational Site Number 8400001
🇺🇸Rolling Hills Estates, California, United States
Investigational Site Number 8400004
🇺🇸Long Beach, California, United States
Investigational Site Number 8400007
🇺🇸Papillion, Nebraska, United States
Investigational Site Number 8400009
🇺🇸Stockton, California, United States
Investigational Site Number 8400025
🇺🇸Edmond, Oklahoma, United States
Investigational Site Number 1520003
🇨🇱Viña Del Mar, Chile
Investigational Site Number 4840001
🇲🇽Monterrey, Mexico
Investigational Site Number 6160007
🇵🇱Krakow, Poland
Investigational Site Number 4840002
🇲🇽Guadalajara, Mexico
Investigational Site Number 4840006
🇲🇽Monterrey, Mexico
Investigational Site Number 8040012
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 8040009
🇺🇦Kharkiv, Ukraine
Investigational Site Number 8040007
🇺🇦Kyiv, Ukraine
Investigational Site Number 8040003
🇺🇦Ternopil, Ukraine
Investigational Site Number 8400016
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 8400020
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400026
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 8400022
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 8400011
🇺🇸Medford, Oregon, United States
Investigational Site Number 8400024
🇺🇸Portland, Oregon, United States
Investigational Site Number 8400010
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400023
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400013
🇺🇸San Jose, California, United States
Investigational Site Number 8400006
🇺🇸Plano, Texas, United States
Investigational Site Number 0320001
🇦🇷Buenos Aires, Argentina
Investigational Site Number 8040006
🇺🇦Odesa, Ukraine