Clinical trial NCT03782532: Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-12-20
Enrollment: 486
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria :

* Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria:
* Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).
* Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).
* Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.
* Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.
* For patients not requiring maintenance OCS, screening blood eosinophil count ≥150 cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level.

Exclusion criteria:

* Patients \<12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, patient recruitment will be restricted to those who are ≥18 years of age).
* Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2).
* Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function.
* A patient who experiences a severe asthma exacerbation (defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2).
* Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care.
* Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1).
* Previous smoker with a smoking history \>10 pack-years.
* Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in pre-bronchodilator forced expiratory volume (FEV1)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Annualized rate of severe exacerbation events
timeFrame: During the 24-week placebo-controlled treatment period
measure: Percent change from baseline in pre-bronchodilator FEV1
timeFrame: Baseline to Week 12
measure: Annualized rate of loss of asthma control (LOAC) event
timeFrame: During the 24-week placebo-controlled treatment period
measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit
timeFrame: During the 24-week placebo-controlled treatment period
measure: Time to first severe exacerbation event
timeFrame: During the 24-week placebo-controlled treatment period
measure: Time to first LOAC
timeFrame: During the 24-week placebo-controlled treatment period
measure: Change from baseline in Asthma Control Questionnaire (ACQ)-5 score
timeFrame: Baseline to Week 24
measure: Change from baseline in ACQ-7 score
timeFrame: Baseline to Week 24
measure: Morning/evening asthma symptom score (e-diary)
timeFrame: Baseline to Week 24
measure: Nocturnal awakenings (e-diary)
timeFrame: Baseline to week 24
measure: Use of daily puffs of rescue medication
timeFrame: Baseline to Week 24
measure: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (≥12 years) (AQLQ+12)
timeFrame: Baseline to Week 24
measure: Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)
timeFrame: Baseline to Week 24
measure: Assessment of adverse events (AEs)
timeFrame: Baseline to week 36
Other outcomes:
Locations:
city: Baotou
country: China
facility: Investigational Site Number :1560013
city: Beijing
country: China
facility: Investigational Site Number :1560016
city: Beijing
country: China
facility: Investigational Site Number :1560029
city: Beijing
country: China
facility: Investigational Site Number :1560015
city: Beijing
country: China
facility: Investigational Site Number :1560056
city: Changchun
country: China
facility: Investigational Site Number :1560057
city: Changsha
country: China
facility: Investigational Site Number :1560010
city: Chengdu
country: China
facility: Investigational Site Number :1560030
city: Chengdu
country: China
facility: Investigational Site Number :1560053
city: Chongqing
country: China
facility: Investigational Site Number :1560025
city: Guangzhou
country: China
facility: Investigational Site Number :1560004
city: Guangzhou
country: China
facility: Investigational Site Number :1560001
city: Guangzhou
country: China
facility: Investigational Site Number :1560045
city: Guiyang
country: China
facility: Investigational Site Number :1560032
city: Hangzhou
country: China
facility: Investigational Site Number :1560019
city: Hangzhou
country: China
facility: Investigational Site Number :1560007
city: Hangzhou
country: China
facility: Investigational Site Number :1560014
city: Hangzhou
country: China
facility: Investigational Site Number :1560026
city: Hangzhou
country: China
facility: Investigational Site Number :1560043
city: Hefei
country: China
facility: Investigational Site Number :1560038
city: Hohhot
country: China
facility: Investigational Site Number :1560044
city: Hohhot
country: China
facility: Investigational Site Number :1560008
city: Lanzhou
country: China
facility: Investigational Site Number :1560022
city: Nanchang
country: China
facility: Investigational Site Number :1560024
city: Nanjing
country: China
facility: Investigational Site Number :1560051
city: Nanjing
country: China
facility: Investigational Site Number :1560054
city: Nanjing
country: China
facility: Investigational Site Number :1560037
city: Pingxiang
country: China
facility: Investigational Site Number :1560035
city: Shanghai
country: China
facility: Investigational Site Number :1560050
city: Shanghai
country: China
facility: Investigational Site Number :1560049
city: Shanghai
country: China
facility: Investigational Site Number :1560005
city: Shanghai
country: China
facility: Investigational Site Number :1560011
city: Shanghai
country: China
facility: Investigational Site Number :1560017
city: Shanghai
country: China
facility: Investigational Site Number :1560006
city: Shanghai
country: China
facility: Investigational Site Number :1560002
city: Shenyang
country: China
facility: Investigational Site Number :1560018
city: Shenyang
country: China
facility: Investigational Site Number :1560036
city: Shenzhen
country: China
facility: Investigational Site Number :1560012
city: Shenzhen
country: China
facility: Investigational Site Number :1560042
city: Shijiazhuang
country: China
facility: Investigational Site Number :1560003
city: Shijiazhuang
country: China
facility: Investigational Site Number :1560041
city: Suzhou
country: China
facility: Investigational Site Number :1560031
city: Taiyuan
country: China
facility: Investigational Site Number :1560048
city: Tianjin
country: China
facility: Investigational Site Number :1560020
city: Urumchi
country: China
facility: Investigational Site Number :1560033
city: Wenzhou
country: China
facility: Investigational Site Number :1560021
city: Wuhan
country: China
facility: Investigational Site Number :1560052
city: Wuhan
country: China
facility: Investigational Site Number :1560028
city: Xi'an
country: China
facility: Investigational Site Number :1560040
city: Xiamen
country: China
facility: Investigational Site Number :1560046
city: Xiangtan
country: China
facility: Investigational Site Number :1560027
city: Xuzhou
country: China
facility: Investigational Site Number :1560023
city: Yangzhou
country: China
facility: Investigational Site Number :1560055
city: Zhanjiang
country: China
facility: Investigational Site Number :1560047
city: Chandigarh
country: India
facility: Investigational Site Number :3560006
city: Coimbatore
country: India
facility: Investigational Site Number :3560002
city: Hyderabad
country: India
facility: Investigational Site Number :3560013
city: Jaipur
country: India
facility: Investigational Site Number :3560005
city: Jaipur
country: India
facility: Investigational Site Number :3560015
city: Kolkata
country: India
facility: Investigational Site Number :3560010
city: Kozhikode
country: India
facility: Investigational Site Number :3560011
city: Mohali
country: India
facility: Investigational Site Number :3560012
city: Nagpur
country: India
facility: Investigational Site Number :3560003
city: Nagpur
country: India
facility: Investigational Site Number :3560016
city: New Delhi
country: India
facility: Investigational Site Number :3560001
city: Pune
country: India
facility: Investigational Site Number :3560009
city: Vellore
country: India
facility: Investigational Site Number :3560007
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: