Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
NCT ID: NCT03782532
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
486 participants
INTERVENTIONAL
2019-01-25
2022-05-21
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dupilumab
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
Dupilumab SAR231893
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
Placebo for dupilumab
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
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
Interventions
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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
Eligibility Criteria
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Inclusion 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
* 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.
12 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :1560006
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 :1560026
Hangzhou, , China
Investigational Site Number :1560043
Hangzhou, , China
Investigational Site Number :1560038
Hefei, , China
Investigational Site Number :1560044
Hohhot, , China
Investigational Site Number :1560008
Hohhot, , China
Investigational Site Number :1560022
Lanzhou, , China
Investigational Site Number :1560024
Nanchang, , China
Investigational Site Number :1560051
Nanjing, , 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 :1560049
Shanghai, , China
Investigational Site Number :1560005
Shanghai, , China
Investigational Site Number :1560011
Shanghai, , China
Investigational Site Number :1560017
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 :1560025
Chongqing, , China
Investigational Site Number :1560004
Guangzhou, , 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 :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
Ürümqi, , 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 :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, , India
Countries
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References
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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.
Related Links
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2022-002375-11 EudraCT results
Other Identifiers
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U1111-1175-0772
Identifier Type: OTHER
Identifier Source: secondary_id
2022-002375-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC13995
Identifier Type: -
Identifier Source: org_study_id