Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782532
• Other study ID #: EFC13995
• Secondary ID: U1111-1175-07722
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2019
• Est. completion date: May 21, 2022

Study information

• Verified date: December 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: May 21, 2022
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dupilumab SAR231893
Pharmaceutical form: Solution Route of administration: Subcutaneous
• Placebo
Pharmaceutical form: Solution Route of administration: Subcutaneous
• Asthma Controller Therapies (include prednisone/prednisolone)
Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral
• Asthma Reliever Therapies
Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled

Locations

Country	Name	City	State
China	Investigational Site Number :1560013	Baotou
China	Investigational Site Number :1560015	Beijing
China	Investigational Site Number :1560016	Beijing
China	Investigational Site Number :1560029	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 :1560025	Chongqing
China	Investigational Site Number :1560001	Guangzhou
China	Investigational Site Number :1560004	Guangzhou
China	Investigational Site Number :1560045	Guangzhou
China	Investigational Site Number :1560032	Guiyang
China	Investigational Site Number :1560007	Hangzhou
China	Investigational Site Number :1560014	Hangzhou
China	Investigational Site Number :1560019	Hangzhou
China	Investigational Site Number :1560026	Hangzhou
China	Investigational Site Number :1560043	Hangzhou
China	Investigational Site Number :1560038	Hefei
China	Investigational Site Number :1560008	Hohhot
China	Investigational Site Number :1560044	Hohhot
China	Investigational Site Number :1560022	Lanzhou
China	Investigational Site Number :1560024	Nanchang
China	Investigational Site Number :1560037	Nanjing
China	Investigational Site Number :1560051	Nanjing
China	Investigational Site Number :1560054	Nanjing
China	Investigational Site Number :1560035	Pingxiang
China	Investigational Site Number :1560002	Shanghai
China	Investigational Site Number :1560005	Shanghai
China	Investigational Site Number :1560006	Shanghai
China	Investigational Site Number :1560011	Shanghai
China	Investigational Site Number :1560017	Shanghai
China	Investigational Site Number :1560049	Shanghai
China	Investigational Site Number :1560050	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 :1560003	Shijiazhuang
China	Investigational Site Number :1560041	Shijiazhuang
China	Investigational Site Number :1560031	Suzhou
China	Investigational Site Number :1560048	Taiyuan
China	Investigational Site Number :1560020	Tianjin
China	Investigational Site Number :1560033	Urumchi
China	Investigational Site Number :1560021	Wenzhou
China	Investigational Site Number :1560028	Wuhan
China	Investigational Site Number :1560052	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
India	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 :3560011	Kozhikode
India	Investigational Site Number :3560012	Mohali
India	Investigational Site Number :3560003	Nagpur
India	Investigational Site Number :3560016	Nagpur
India	Investigational Site Number :3560001	New Delhi
India	Investigational Site Number :3560009	Pune
India	Investigational Site Number :3560007	Vellore

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

China,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pre-bronchodilator forced expiratory volume (FEV1)	Absolute change from baseline in pre-bronchodilator FEV1 at Week 12	Baseline to Week 12
Secondary	Annualized rate of severe exacerbation events	Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period	During the 24-week placebo-controlled treatment period
Secondary	Percent change from baseline in pre-bronchodilator FEV1	Percent change from baseline in pre-bronchodilator FEV1 at Week 12	Baseline to Week 12
Secondary	Annualized rate of loss of asthma control (LOAC) event	Annualized rate of LOAC event during the 24-week placebo-controlled treatment period	During the 24-week placebo-controlled treatment period
Secondary	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit	Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit during the 24-week placebo-controlled treatment period	During the 24-week placebo-controlled treatment period
Secondary	Time to first severe exacerbation event	Time to first severe exacerbation event during the 24-week placebo-controlled treatment period	During the 24-week placebo-controlled treatment period
Secondary	Time to first LOAC	Time to first LOAC during the 24-week placebo-controlled treatment period	During the 24-week placebo-controlled treatment period
Secondary	Change from baseline in Asthma Control Questionnaire (ACQ)-5 score	Change from baseline in ACQ-5 score at Week 24	Baseline to Week 24
Secondary	Change from baseline in ACQ-7 score	Change from baseline in ACQ-7 score at Week 24	Baseline to Week 24
Secondary	Morning/evening asthma symptom score (e-diary)	Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)	Baseline to Week 24
Secondary	Nocturnal awakenings (e-diary)	Change from baseline at Week 24 in nocturnal awakenings (e-diary)	Baseline to week 24
Secondary	Use of daily puffs of rescue medication	Change from baseline at Week 24 in use of daily puffs of rescue medication	Baseline to Week 24
Secondary	Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) with Standardized Activities (=12 years) (AQLQ+12)	Change from baseline in AQLQ with Standardized Activities (=12 years) (AQLQ+12) at Week 24	Baseline to Week 24
Secondary	Change from baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L)	Change from baseline in EQ-5D-5L at Week 24	Baseline to Week 24
Secondary	Assessment of adverse events (AEs)	Number of participants with adverse events (AEs)	Baseline to week 36