A Phase 4 interventional study of Dupilumab and Placebo in Asthma, sponsored by Sanofi. Completed at 65 sites in 13 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary Objective:
Secondary Objective:
The study duration for each participant was a total of minimum 29 weeks and up to 41 weeks. This included 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the participants switched to commercialized dupilumab (or other biologic products), whatever came first.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 109 is above the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
NOTES:
Exclusion Criteria:
Participants with any of the following results at V1:
Treatment with live (attenuated) vaccine within 4 weeks before V1. For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician, whether the administration of vaccine can be postponed until after the end of the study, or preponed to before the start of the study without compromising the health of the participant:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Participants received a loading dose of dupilumab 600 mg as 2 subcutaneous (SC) injections on Day 1, followed by a single dupilumab 300 mg SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller.
Drug: Dupilumab
Participants received placebo matched to dupilumab as 2 x 2 mL SC injections on Day 1, followed by a single SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller.
Drug: Placebo
solution for injection subcutaneous
Also known as: SAR231893 Dupixent
Solution for injection subcutaneous
Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24
FeNO was analyzed using a NIOX instrument using a flow rate of 50 milliliters per second (mL/s). This assessment was conducted prior to spirometry and following a fast of greater than or equal to (≥1) hour. The test was performed after a wash out period of bronchodilators.
Time frame: Week 24
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC)
Specific airway volume \[(s)iVaw\] is the change of volume of the airways (in mL), taking into account the lung volume changes (in liter \[L\]) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. This way the air volumes are normalized across participants and become specific. Untrimmed distal \[s\]iVaw at TLC was assessed based on 3-dimensional (D) rendering of high-resolution computed tomography (HRCT) scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of investigational medicinal product (IMP).
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Global Lung Mucus Score (University of California, San Francisco [UCSF] Mucus Scoring)
The mucus scoring system was derived, with very minor differences, from UCSF mucus score. The mucus score was calculated by counting the number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug\[s\] present) or 0 (mucus plug\[s\] absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores indicate worse outcome. Baseline was defined as the last available valid (non-missing) value up to and including the date of first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at TLC
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal (\[s\]iRaw) at TLC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Functional Residual Capacity (FRC)
(s)iVaw is the change of volume of the airways (mL), taking into account the lung volume changes (in L) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. Untrimmed distal \[s\]iVaw at FRC was assessed based on 3-D rendering of HRCT scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at FRC
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal \[s\]iRaw at FRC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Global Lung Lobar Volumes (iVlobes) at TLC
The lung volume was determined from the HRCT scan at TLC, by identifying and grouping the voxels that represent the air in the lungs. The total lung volume along with the volume of each lobe individually was determined which allowed to pick up substantial regional physiological changes of the airways and the lobe volumes. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in HRCT-Based Internal Airflow Distribution (IAD) for Each Lung Zone
The IAD was assessed in the upper and lower lung using HRCT scan. By segmenting the lobes at FRC and TLC for each participant, the participant-specific airflow distribution can be established by assessing lobar and volume expansion. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Image-Based Ventilation/Perfusion (iV/Q) at TLC for Each Lung Zone
Blood vessel density can be considered a surrogate for perfusion, hence image-based perfusion (IQ) is calculated by blood vessel density at TLC multiplied by image-based volume at TLC. Image-based ventilation (IV) is calculated by the imaged volume at TLC subtracted from the image-based volume at FRC. The ventilation/perfusion ratio IV/Q is then the ratio IV/IQ. The iV/Q was assessed in the upper and lower lung using HRCT scan at TLC. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in FeNO
FeNO was analyzed using a NIOX instrument using a flow rate of 50 mL/s. This assessment was conducted prior to spirometry and following a fast of ≥1 hour. The test was performed after a wash out period of bronchodilators. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration. Lung function parameters: pre- and post-bronchodilator FEV1 were measured by spirometry before IMP administration. Spirometry was performed after a wash out period of bronchodilators. Post-BD FEV1 was measured within 30 minutes after short-acting beta-2 agonists (2 to up to 4 puffs of albuterol/salbutamol) administration. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in 7 Item Asthma Control Questionnaire (ACQ-7)
The ACQ-7 comprises of 7 items:first 5 items assess most common asthma symptoms: 1. frequency in past week awoken by asthma during the night; 2. severity of asthma symptoms in the morning; 3. limitation of daily activities due to asthma; 4. shortness of breath due to asthma; and 5. wheeze; plus questions 6. short-acting bronchodilator use; and 7. FEV1 (pre-bronchodilator use, % and % predicted use).Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment).Clinic staff scores the FEV1% predicted on a 7-point scale.A global score is calculated: the questions are equally weighted, and the overall ACQ-7 score is the mean of the 7 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled).Higher score indicates lower asthma control. Baseline=last available valid (non-missing) value up to and including day of the first dose of IMP.
Time frame: Baseline (Day 1) to Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
AE: any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs: AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP (on Day 1) to the last administration of the IMP + 98 days and up to the end of the study follow-up. Serious adverse events (SAE): AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI: AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required.
Time frame: From first dose of study drug (Day 1) up to end of study (up to 36 weeks)
A total of 317 participants were screened from 20 Jun 2020 to 06 Jan 2023 at 72 study sites in 14 countries of which 208 participants were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
| Milestone | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Started | 72 | 37 |
| Completed | 70 | 33 |
| Not completed | 2 | 4 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Not related to coronavirus disease 2019 pandemic | 0 | 3 |
FeNO was analyzed using a NIOX instrument using a flow rate of 50 milliliters per second (mL/s). This assessment was conducted prior to spirometry and following a fast of greater than or equal to (≥1) hour. The test was performed after a wash out period of bronchodilators.
| percentage of participants | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24 | 56.9 | 10.8 |
Specific airway volume \[(s)iVaw\] is the change of volume of the airways (in mL), taking into account the lung volume changes (in liter \[L\]) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. This way the air volumes are normalized across participants and become specific. Untrimmed distal \[s\]iVaw at TLC was assessed based on 3-dimensional (D) rendering of high-resolution computed tomography (HRCT) scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of investigational medicinal product (IMP).
| percent change | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC) | 19.73 ± 8.102 | -2.04 ± 11.538 |
The mucus scoring system was derived, with very minor differences, from UCSF mucus score. The mucus score was calculated by counting the number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug\[s\] present) or 0 (mucus plug\[s\] absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores indicate worse outcome. Baseline was defined as the last available valid (non-missing) value up to and including the date of first dose of IMP.
| score on a scale | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in Global Lung Mucus Score (University of California, San Francisco [UCSF] Mucus Scoring) | -3.48 ± 0.463 | 1.44 ± 0.656 |
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal (\[s\]iRaw) at TLC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
| percent change | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at TLC | 36.85 ± 22.562 | 90.30 ± 32.541 |
(s)iVaw is the change of volume of the airways (mL), taking into account the lung volume changes (in L) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. Untrimmed distal \[s\]iVaw at FRC was assessed based on 3-D rendering of HRCT scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
| percent change | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Functional Residual Capacity (FRC) | 225.91 ± 92.250 | -17.07 ± 129.384 |
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal \[s\]iRaw at FRC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
| percent change | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at FRC | 98.73 ± 70.143 | 207.87 ± 98.445 |
The lung volume was determined from the HRCT scan at TLC, by identifying and grouping the voxels that represent the air in the lungs. The total lung volume along with the volume of each lobe individually was determined which allowed to pick up substantial regional physiological changes of the airways and the lobe volumes. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
| percent change | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Percent Change From Baseline to Week 24 in Global Lung Lobar Volumes (iVlobes) at TLC | -0.98 ± 1.691 | -3.74 ± 2.401 |
The IAD was assessed in the upper and lower lung using HRCT scan. By segmenting the lobes at FRC and TLC for each participant, the participant-specific airflow distribution can be established by assessing lobar and volume expansion. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
| percentage of IAD | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Upper Lung | -0.61 ± 0.803 | -0.11 ± 1.133 |
| Lower Lung | 0.61 ± 0.803 | 0.11 ± 1.133 |
Blood vessel density can be considered a surrogate for perfusion, hence image-based perfusion (IQ) is calculated by blood vessel density at TLC multiplied by image-based volume at TLC. Image-based ventilation (IV) is calculated by the imaged volume at TLC subtracted from the image-based volume at FRC. The ventilation/perfusion ratio IV/Q is then the ratio IV/IQ. The iV/Q was assessed in the upper and lower lung using HRCT scan at TLC. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
| Ratio | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Upper Lung | 1.42 ± 0.538 | -0.45 ± 0.758 |
| Lower Lung | 1.75 ± 0.579 | -0.91 ± 0.817 |
FeNO was analyzed using a NIOX instrument using a flow rate of 50 mL/s. This assessment was conducted prior to spirometry and following a fast of ≥1 hour. The test was performed after a wash out period of bronchodilators. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
| parts per billion | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in FeNO | -35.49 ± 2.440 | -12.56 ± 3.444 |
FEV1 was the volume of air exhaled in the first second of a forced expiration. Lung function parameters: pre- and post-bronchodilator FEV1 were measured by spirometry before IMP administration. Spirometry was performed after a wash out period of bronchodilators. Post-BD FEV1 was measured within 30 minutes after short-acting beta-2 agonists (2 to up to 4 puffs of albuterol/salbutamol) administration. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
| liter | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Pre-Bronchodilator FEV1 | 0.655 ± 0.0637 | 0.274 ± 0.0885 |
| Post-Bronchodilator FEV1 | 0.468 ± 0.0661 | 0.151 ± 0.0928 |
The ACQ-7 comprises of 7 items:first 5 items assess most common asthma symptoms: 1. frequency in past week awoken by asthma during the night; 2. severity of asthma symptoms in the morning; 3. limitation of daily activities due to asthma; 4. shortness of breath due to asthma; and 5. wheeze; plus questions 6. short-acting bronchodilator use; and 7. FEV1 (pre-bronchodilator use, % and % predicted use).Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment).Clinic staff scores the FEV1% predicted on a 7-point scale.A global score is calculated: the questions are equally weighted, and the overall ACQ-7 score is the mean of the 7 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled).Higher score indicates lower asthma control. Baseline=last available valid (non-missing) value up to and including day of the first dose of IMP.
| score on a scale | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Change From Baseline to Week 24 in 7 Item Asthma Control Questionnaire (ACQ-7) | -1.36 ± 0.101 | -0.62 ± 0.143 |
AE: any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs: AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP (on Day 1) to the last administration of the IMP + 98 days and up to the end of the study follow-up. Serious adverse events (SAE): AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI: AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required.
| Participants | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| Any TEAE | 31 | 21 |
| Any TESAE | 3 | 1 |
| Any AESI | 1 | 0 |
Collected over From first dose of study drug (Day 1) up to end of study (up to 36 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dupilumab 300 mg Q2W | 0/72 (0%) | 3/72 (4.2%) | 18/72 (25%) |
| Placebo | 0/37 (0%) | 1/37 (2.7%) | 15/37 (40.5%) |
| Event | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/72 | 1/37 |
| EosinophiliaBlood and lymphatic system disorders | 1/72 | 0/37 |
| Eosinophilic Granulomatosis With PolyangiitisImmune system disorders | 1/72 | 0/37 |
| Facial Bones FractureInjury, poisoning and procedural complications | 1/72 | 0/37 |
| Soft Tissue InjuryInjury, poisoning and procedural complications | 1/72 | 0/37 |
| Event | Dupilumab 300 mg Q2W | Placebo |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/72 | 9/37 |
| Covid-19Infections and infestations | 7/72 | 3/37 |
| HeadacheNervous system disorders | 5/72 | 3/37 |
| Injection Site ReactionGeneral disorders | 4/72 | 1/37 |
| NauseaGastrointestinal disorders | 0/72 | 2/37 |
| PneumoniaInfections and infestations | 0/72 | 2/37 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/72 | 2/37 |
| Sleep Apnoea SyndromeRespiratory, thoracic and mediastinal disorders | 0/72 | 2/37 |
The Intent-to-Treat (ITT) analysis set consisted of randomized participant (participant with a study intervention kit number allocated and recorded in the interactive voice recognition system \[IVRS\]/ interactive web response system \[IWRS\] database, regardless of whether the study intervention kit was used or not).
| Age, Continuous(years) | Dupilumab 300 mg Q2W | Placebo | Total |
|---|---|---|---|
| Mean | 51.0 ± 12.81 | 49.4 ± 12.33 | 50.4 ± 12.62 |
| Sex: Female, Male(Participants) | Dupilumab 300 mg Q2W | Placebo | Total |
|---|---|---|---|
| Female | 46 | 22 | 68 |
| Male | 26 | 15 | 41 |
| Race (NIH/OMB)(Participants) | Dupilumab 300 mg Q2W | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 2 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 64 | 34 | 98 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC)(mL) | Dupilumab 300 mg Q2W | Placebo | Total |
|---|---|---|---|
| Mean | 1.90526 ± 0.954024 | 1.90562 ± 1.161739 | 1.90539 ± 1.022934 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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
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