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AsthmaPhase 3NCT03782532

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

A Phase 3 study testing Dupilumab SAR231893 and Asthma Reliever Therapies in people with Asthma, run by Sanofi at 67 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Dupilumab SAR231893 and Asthma Reliever Therapies
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
486 participants
Where
67 sitesin 2 countries
Study dates
25 Jan 2019to 21 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • 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.

Trial locations and contacts

67 sites in 2 countries.

67 sites in 2 countries

China54 sites

  • Investigational Site Number :1560013

    Baotou, 014010

  • Investigational Site Number :1560016

    Beijing, 100020

  • Investigational Site Number :1560029

    Beijing, 100029

  • Investigational Site Number :1560015

    Beijing, 100034

  • Investigational Site Number :1560056

    Beijing

  • Investigational Site Number :1560057

    Changchun, 130041

  • Investigational Site Number :1560010

    Changsha, 410013

  • Investigational Site Number :1560030

    Chengdu, 610041

  • Investigational Site Number :1560053

    Chengdu

  • Investigational Site Number :1560025

    Chongqing, 400038

  • Investigational Site Number :1560004

    Guangzhou, 510080

  • Investigational Site Number :1560001

    Guangzhou, 510120

  • Investigational Site Number :1560045

    Guangzhou, 510150

  • Investigational Site Number :1560032

    Guiyang, 550002

  • Investigational Site Number :1560019

    Hangzhou, 310003

  • Investigational Site Number :1560007

    Hangzhou, 310006

  • Investigational Site Number :1560014

    Hangzhou, 310009

  • Investigational Site Number :1560026

    Hangzhou, 310016

  • Investigational Site Number :1560043

    Hangzhou

  • Investigational Site Number :1560038

    Hefei

  • Investigational Site Number :1560044

    Hohhot, 010017

  • Investigational Site Number :1560008

    Hohhot, 010050

  • Investigational Site Number :1560022

    Lanzhou, 730000

  • Investigational Site Number :1560024

    Nanchang, 330006

  • Investigational Site Number :1560051

    Nanjing, 210005

  • Investigational Site Number :1560054

    Nanjing, 210006

  • Investigational Site Number :1560037

    Nanjing, 210029

  • Investigational Site Number :1560035

    Pingxiang, 337055

  • Investigational Site Number :1560050

    Shanghai, 200025

  • Investigational Site Number :1560049

    Shanghai, 200030

  • Investigational Site Number :1560005

    Shanghai, 200032

  • Investigational Site Number :1560011

    Shanghai, 200080

  • Investigational Site Number :1560017

    Shanghai, 200120

  • Investigational Site Number :1560006

    Shanghai, 200233

  • Investigational Site Number :1560002

    Shanghai, 200433

  • Investigational Site Number :1560018

    Shenyang, 110001

  • Investigational Site Number :1560036

    Shenyang, 110004

  • Investigational Site Number :1560012

    Shenzhen, 518020

  • Investigational Site Number :1560042

    Shenzhen, 518102

  • Investigational Site Number :1560003

    Shijiazhuang, 050000

  • Investigational Site Number :1560041

    Shijiazhuang, 050041

  • Investigational Site Number :1560031

    Suzhou, 215006

  • Investigational Site Number :1560048

    Taiyuan, 030001

  • Investigational Site Number :1560020

    Tianjin, 300052

  • Investigational Site Number :1560033

    Ürümqi, 830054

  • Investigational Site Number :1560021

    Wenzhou, 325000

  • Investigational Site Number :1560052

    Wuhan, 430000

  • Investigational Site Number :1560028

    Wuhan, 430030

  • Investigational Site Number :1560040

    Xi'an

  • Investigational Site Number :1560046

    Xiamen, 361004

  • Investigational Site Number :1560027

    Xiangtan

  • Investigational Site Number :1560023

    Xuzhou, 221002

  • Investigational Site Number :1560055

    Yangzhou, 225001

  • Investigational Site Number :1560047

    Zhanjiang, 524001

Other trials in China

India13 sites

  • Investigational Site Number :3560006

    Chandigarh, 160012

  • Investigational Site Number :3560002

    Coimbatore, 641028

  • Investigational Site Number :3560013

    Hyderabad, 500082

  • Investigational Site Number :3560005

    Jaipur, 302023

  • Investigational Site Number :3560015

    Jaipur, 302039

  • Investigational Site Number :3560010

    Kolkata, 700107

  • Investigational Site Number :3560011

    Kozhikode, 673008

  • Investigational Site Number :3560012

    Mohali, 160062

  • Investigational Site Number :3560003

    Nagpur, 440012

  • Investigational Site Number :3560016

    Nagpur, 440012

  • Investigational Site Number :3560001

    New Delhi, 110060

  • Investigational Site Number :3560009

    Pune, 411001

  • Investigational Site Number :3560007

    Vellore, 632004

Other trials in India

About this study

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

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
Read the 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.

Conditions
Asthma
Being tested
Dupilumab SAR231893, Placebo, Asthma Controller Therapies (include prednisone/prednisolone), Asthma Reliever Therapies
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dupilumab SAR231893Drug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • PlaceboDrug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

  • Asthma Controller Therapies (include prednisone/prednisolone)Drug

    Pharmaceutical form: Aerosol, capsules, tablets, oral solution

    Route of administration: Inhalation, oral

  • Asthma Reliever TherapiesDrug

    Pharmaceutical form: Nebulized, aerosol

    Route of administration: Inhaled

Study groups in NCT03782532
Study groupRoleWhat they receive
DupilumabExperimentalFor 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
Receives: Drug: Dupilumab SAR231893; Drug: Asthma Controller Therapies (include prednisone/prednisolone); Drug: Asthma Reliever Therapies
Placebo for dupilumabPlacebo 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
Receives: Drug: Placebo; Drug: Asthma Controller Therapies (include prednisone/prednisolone); Drug: Asthma Reliever Therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pre-bronchodilator forced expiratory volume (FEV1)

    Absolute change from baseline in pre-bronchodilator FEV1 at Week 12

    Measured: Baseline to Week 12

Secondary outcomes (14)

  1. Annualized rate of severe exacerbation events

    Annualized rate of severe exacerbation events during the 24-week placebo-controlled treatment period

    Measured: During the 24-week placebo-controlled treatment period

  2. Percent change from baseline in pre-bronchodilator FEV1

    Percent change from baseline in pre-bronchodilator FEV1 at Week 12

    Measured: Baseline to Week 12

  3. Annualized rate of loss of asthma control (LOAC) event

    Annualized rate of LOAC event during the 24-week placebo-controlled treatment period

    Measured: During the 24-week placebo-controlled treatment period

  4. 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

    Measured: During the 24-week placebo-controlled treatment period

  5. Time to first severe exacerbation event

    Time to first severe exacerbation event during the 24-week placebo-controlled treatment period

    Measured: During the 24-week placebo-controlled treatment period

  6. Time to first LOAC

    Time to first LOAC during the 24-week placebo-controlled treatment period

    Measured: During the 24-week placebo-controlled treatment period

  7. Change from baseline in Asthma Control Questionnaire (ACQ)-5 score

    Change from baseline in ACQ-5 score at Week 24

    Measured: Baseline to Week 24

  8. Change from baseline in ACQ-7 score

    Change from baseline in ACQ-7 score at Week 24

    Measured: Baseline to Week 24

  9. Morning/evening asthma symptom score (e-diary)

    Change from baseline at Week 24 in morning/evening asthma symptom score (e-diary)

    Measured: Baseline to Week 24

  10. Nocturnal awakenings (e-diary)

    Change from baseline at Week 24 in nocturnal awakenings (e-diary)

    Measured: Baseline to week 24

  11. Use of daily puffs of rescue medication

    Change from baseline at Week 24 in use of daily puffs of rescue medication

    Measured: Baseline to Week 24

  12. 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

    Measured: Baseline to Week 24

  13. 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

    Measured: Baseline to Week 24

  14. Assessment of adverse events (AEs)

    Number of participants with adverse events (AEs)

    Measured: Baseline to week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start25 Jan 2019
  3. Primary completion21 May 2022
  4. Study completion21 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03782532
Sponsor's protocol ID
EFC13995
Other IDs
U1111-1175-0772, 2022-002375-11
Status last verified
Dec 2022
First submitted
5 Dec 2018
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39988927

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dupilumab SAR231893 and Asthma Reliever Therapies in people with Asthma, run by Sanofi at 67 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in China, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pre-bronchodilator forced expiratory volume (FEV1) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03782532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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