Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
3 other identifiers
interventional
486
2 countries
67
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jan 2019
Longer than P75 for phase_3 asthma
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
January 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2022
CompletedDecember 28, 2022
December 1, 2022
3.3 years
December 5, 2018
December 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in pre-bronchodilator forced expiratory volume (FEV1)
Absolute change from baseline in pre-bronchodilator FEV1 at Week 12
Baseline to Week 12
Secondary Outcomes (14)
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
Annualized rate of loss of asthma control (LOAC) event
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
Time to first severe exacerbation event
During the 24-week placebo-controlled treatment period
- +9 more secondary outcomes
Study Arms (2)
Dupilumab
EXPERIMENTALFor 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 COMPARATORFor 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
Interventions
Pharmaceutical form: Aerosol, capsules, tablets, oral solution Route of administration: Inhalation, oral
Pharmaceutical form: Nebulized, aerosol Route of administration: Inhaled
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (67)
Investigational Site Number :1560013
Baotou, 014010, China
Investigational Site Number :1560016
Beijing, 100020, China
Investigational Site Number :1560029
Beijing, 100029, China
Investigational Site Number :1560015
Beijing, 100034, China
Investigational Site Number :1560056
Beijing, China
Investigational Site Number :1560057
Changchun, 130041, China
Investigational Site Number :1560010
Changsha, 410013, China
Investigational Site Number :1560030
Chengdu, 610041, China
Investigational Site Number :1560053
Chengdu, China
Investigational Site Number :1560025
Chongqing, 400038, China
Investigational Site Number :1560004
Guangzhou, 510080, China
Investigational Site Number :1560001
Guangzhou, 510120, China
Investigational Site Number :1560045
Guangzhou, 510150, China
Investigational Site Number :1560032
Guiyang, 550002, China
Investigational Site Number :1560019
Hangzhou, 310003, China
Investigational Site Number :1560007
Hangzhou, 310006, China
Investigational Site Number :1560014
Hangzhou, 310009, China
Investigational Site Number :1560026
Hangzhou, 310016, China
Investigational Site Number :1560043
Hangzhou, China
Investigational Site Number :1560038
Hefei, China
Investigational Site Number :1560044
Hohhot, 010017, China
Investigational Site Number :1560008
Hohhot, 010050, China
Investigational Site Number :1560022
Lanzhou, 730000, China
Investigational Site Number :1560024
Nanchang, 330006, China
Investigational Site Number :1560051
Nanjing, 210005, China
Investigational Site Number :1560054
Nanjing, 210006, China
Investigational Site Number :1560037
Nanjing, 210029, China
Investigational Site Number :1560035
Pingxiang, 337055, China
Investigational Site Number :1560050
Shanghai, 200025, China
Investigational Site Number :1560049
Shanghai, 200030, China
Investigational Site Number :1560005
Shanghai, 200032, China
Investigational Site Number :1560011
Shanghai, 200080, China
Investigational Site Number :1560017
Shanghai, 200120, China
Investigational Site Number :1560006
Shanghai, 200233, China
Investigational Site Number :1560002
Shanghai, 200433, China
Investigational Site Number :1560018
Shenyang, 110001, China
Investigational Site Number :1560036
Shenyang, 110004, China
Investigational Site Number :1560012
Shenzhen, 518020, China
Investigational Site Number :1560042
Shenzhen, 518102, China
Investigational Site Number :1560003
Shijiazhuang, 050000, China
Investigational Site Number :1560041
Shijiazhuang, 050041, China
Investigational Site Number :1560031
Suzhou, 215006, China
Investigational Site Number :1560048
Taiyuan, 030001, China
Investigational Site Number :1560020
Tianjin, 300052, China
Investigational Site Number :1560033
Ürümqi, 830054, China
Investigational Site Number :1560021
Wenzhou, 325000, China
Investigational Site Number :1560052
Wuhan, 430000, China
Investigational Site Number :1560028
Wuhan, 430030, China
Investigational Site Number :1560040
Xi'an, China
Investigational Site Number :1560046
Xiamen, 361004, China
Investigational Site Number :1560027
Xiangtan, China
Investigational Site Number :1560023
Xuzhou, 221002, China
Investigational Site Number :1560055
Yangzhou, 225001, China
Investigational Site Number :1560047
Zhanjiang, 524001, China
Investigational Site Number :3560006
Chandigarh, 160012, India
Investigational Site Number :3560002
Coimbatore, 641028, India
Investigational Site Number :3560013
Hyderabad, 500082, India
Investigational Site Number :3560005
Jaipur, 302023, India
Investigational Site Number :3560015
Jaipur, 302039, India
Investigational Site Number :3560010
Kolkata, 700107, India
Investigational Site Number :3560011
Kozhikode, 673008, India
Investigational Site Number :3560012
Mohali, 160062, India
Investigational Site Number :3560003
Nagpur, 440012, India
Investigational Site Number :3560016
Nagpur, 440012, India
Investigational Site Number :3560001
New Delhi, 110060, India
Investigational Site Number :3560009
Pune, 411001, India
Investigational Site Number :3560007
Vellore, 632004, India
Related Publications (1)
Zhang Q, Zhong N, Dhooria S, Fu X, Fang H, Lin J, Zhu S, Laws E, Wang Y, Li V, Hu CC, Maloney J, Abdulai RM, Robinson LB. Dupilumab Efficacy and Safety in Patients With Persistent Asthma: Asia-Pacific Region. Clin Exp Allergy. 2025 Aug;55(8):691-700. doi: 10.1111/cea.70005. Epub 2025 Feb 23.
PMID: 39988927DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2018
First Posted
December 20, 2018
Study Start
January 25, 2019
Primary Completion
May 21, 2022
Study Completion
May 21, 2022
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org