Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
- Conditions
- Asthma
- Interventions
- Drug: PlaceboDrug: Asthma Controller Therapies (include prednisone/prednisolone)Drug: Asthma Reliever Therapies
- Registration Number
- NCT03782532
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the efficacy of dupilumab in patients with persistent asthma
Secondary Objectives:
* To evaluate the safety and tolerability of dupilumab
* To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life
* To evaluate dupilumab systemic exposure and immunogenicity
- Detailed Description
The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 486
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab SAR231893 For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2 Placebo for dupilumab Asthma Reliever Therapies For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose Dupilumab Asthma Controller Therapies (include prednisone/prednisolone) For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2 Placebo for dupilumab Asthma Controller Therapies (include prednisone/prednisolone) For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose Dupilumab Asthma Reliever Therapies For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2 Placebo for dupilumab Placebo For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose
- Primary Outcome Measures
Name Time Method Change in pre-bronchodilator forced expiratory volume (FEV1) Baseline to Week 12 Absolute change from baseline in pre-bronchodilator FEV1 at Week 12
- Secondary Outcome Measures
Name Time Method Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit During the 24-week placebo-controlled treatment period Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period
Morning/evening asthma symptom score (e-diary) Baseline to Week 24 Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)
Change from baseline in Asthma Control Questionnaire (ACQ)-5 score Baseline to Week 24 Change from baseline in ACQ-5 score at Week 24
Change from baseline in ACQ-7 score Baseline to Week 24 Change from baseline in ACQ-7 score at Week 24
Nocturnal awakenings (e-diary) Baseline to week 24 Change from baseline at Week 24 in nocturnal awakenings (e-diary)
Annualized rate of severe exacerbation events During the 24-week placebo-controlled treatment period Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period
Percent change from baseline in pre-bronchodilator FEV1 Baseline to Week 12 Percent change from baseline in pre-bronchodilator FEV1 at Week 12
Annualized rate of loss of asthma control (LOAC) event During the 24-week placebo-controlled treatment period Annualized rate of LOAC event during the 24-week placebo-controlled treatment period
Time to first severe exacerbation event During the 24-week placebo-controlled treatment period Time to first severe exacerbation event during the 24-week placebo-controlled treatment period
Time to first LOAC During the 24-week placebo-controlled treatment period Time to first LOAC during the 24-week placebo-controlled treatment period
Use of daily puffs of rescue medication Baseline to Week 24 Change from baseline at Week 24 in use of daily puffs of rescue medication
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12) Baseline to Week 24 Change from baseline in AQLQ with Standardized Activities (≥12 years) (AQLQ+12) at Week 24
Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Baseline to Week 24 Change from baseline in EQ-5D-5L at Week 24
Assessment of adverse events (AEs) Baseline to week 36 Number of participants with adverse events (AEs)
Trial Locations
- Locations (67)
Investigational Site Number :3560009
🇮🇳Pune, India
Investigational Site Number :1560025
🇨🇳Chongqing, China
Investigational Site Number :1560004
🇨🇳Guangzhou, China
Investigational Site Number :1560038
🇨🇳Hefei, China
Investigational Site Number :1560049
🇨🇳Shanghai, China
Investigational Site Number :1560013
🇨🇳Baotou, China
Investigational Site Number :1560016
🇨🇳Beijing, China
Investigational Site Number :1560029
🇨🇳Beijing, China
Investigational Site Number :1560015
🇨🇳Beijing, China
Investigational Site Number :1560056
🇨🇳Beijing, China
Investigational Site Number :1560057
🇨🇳Changchun, China
Investigational Site Number :1560010
🇨🇳Changsha, China
Investigational Site Number :1560030
🇨🇳Chengdu, China
Investigational Site Number :1560053
🇨🇳Chengdu, China
Investigational Site Number :1560001
🇨🇳Guangzhou, China
Investigational Site Number :1560045
🇨🇳Guangzhou, China
Investigational Site Number :1560032
🇨🇳Guiyang, China
Investigational Site Number :1560019
🇨🇳Hangzhou, China
Investigational Site Number :1560007
🇨🇳Hangzhou, China
Investigational Site Number :1560014
🇨🇳Hangzhou, China
Investigational Site Number :1560026
🇨🇳Hangzhou, China
Investigational Site Number :1560043
🇨🇳Hangzhou, China
Investigational Site Number :1560044
🇨🇳Hohhot, China
Investigational Site Number :1560024
🇨🇳Nanchang, China
Investigational Site Number :1560008
🇨🇳Hohhot, China
Investigational Site Number :1560022
🇨🇳Lanzhou, China
Investigational Site Number :1560054
🇨🇳Nanjing, China
Investigational Site Number :1560037
🇨🇳Nanjing, China
Investigational Site Number :1560035
🇨🇳Pingxiang, China
Investigational Site Number :1560050
🇨🇳Shanghai, China
Investigational Site Number :1560005
🇨🇳Shanghai, China
Investigational Site Number :1560011
🇨🇳Shanghai, China
Investigational Site Number :1560006
🇨🇳Shanghai, China
Investigational Site Number :1560017
🇨🇳Shanghai, China
Investigational Site Number :1560002
🇨🇳Shanghai, China
Investigational Site Number :1560018
🇨🇳Shenyang, China
Investigational Site Number :1560036
🇨🇳Shenyang, China
Investigational Site Number :1560012
🇨🇳Shenzhen, China
Investigational Site Number :1560042
🇨🇳Shenzhen, China
Investigational Site Number :1560048
🇨🇳Taiyuan, China
Investigational Site Number :1560003
🇨🇳Shijiazhuang, China
Investigational Site Number :1560041
🇨🇳Shijiazhuang, China
Investigational Site Number :1560031
🇨🇳Suzhou, China
Investigational Site Number :1560020
🇨🇳Tianjin, China
Investigational Site Number :1560033
🇨🇳Urumchi, China
Investigational Site Number :1560021
🇨🇳Wenzhou, China
Investigational Site Number :1560052
🇨🇳Wuhan, China
Investigational Site Number :1560028
🇨🇳Wuhan, China
Investigational Site Number :1560040
🇨🇳Xi'an, China
Investigational Site Number :1560046
🇨🇳Xiamen, China
Investigational Site Number :1560027
🇨🇳Xiangtan, China
Investigational Site Number :1560023
🇨🇳Xuzhou, China
Investigational Site Number :1560055
🇨🇳Yangzhou, China
Investigational Site Number :1560047
🇨🇳Zhanjiang, China
Investigational Site Number :3560006
🇮🇳Chandigarh, India
Investigational Site Number :3560002
🇮🇳Coimbatore, India
Investigational Site Number :3560013
🇮🇳Hyderabad, India
Investigational Site Number :3560005
🇮🇳Jaipur, India
Investigational Site Number :3560015
🇮🇳Jaipur, India
Investigational Site Number :3560010
🇮🇳Kolkata, India
Investigational Site Number :3560012
🇮🇳Mohali, India
Investigational Site Number :3560011
🇮🇳Kozhikode, India
Investigational Site Number :3560016
🇮🇳Nagpur, India
Investigational Site Number :3560001
🇮🇳New Delhi, India
Investigational Site Number :3560007
🇮🇳Vellore, India
Investigational Site Number :3560003
🇮🇳Nagpur, India
Investigational Site Number :1560051
🇨🇳Nanjing, China