A Phase 3 interventional study of Dupilumab SAR231893 and Inhaled Corticosteroid in Chronic Obstructive Pulmonary Disease, sponsored by Sanofi. Completed at 334 sites in 29 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by
Secondary Objectives:
To evaluate the effect of dupilumab administered every 2 weeks on
Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 935 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Counted across the registry records on this site, refreshed daily.
Participants with a physician diagnosis of COPD who met the following criteria at screening:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks
Drug: Dupilumab SAR231893 · Drug: Inhaled Corticosteroid · Drug: Inhaled Long-Acting Beta Agonist · Drug: Inhaled Long-Acting Muscarinic Antagonist
Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks
Drug: Inhaled Corticosteroid · Drug: Inhaled Long-Acting Beta Agonist · Drug: Inhaled Long-Acting Muscarinic Antagonist · Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Also known as: Dupixent
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
Time frame: Baseline (Day 1) to Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Week 12
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52
The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had a unique empirically derived weight where lowest possible weight was 0 and the highest was 100. Total score was obtained by summing all positive responses in the questionnaire. The total score and domain score was derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating worse health status/health related quality of life. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Week 52
Percentage of Participants With Saint George's Respiratory Questionnaire Improvement ≥4 Points at Week 52
A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by ≥4 points. Percentage of participants who achieved a clinically meaningful response in SGRQ total score (improvement by ≥4 points)/responders are reported. SGRQ is a 50-item self-administered questionnaire. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had unique empirically derived weight where lowest possible weight was 0 and highest was 100. Total score was obtained by summing all positive responses in questionnaire. Total score and domain score was derived from relevant items and converted to a score of 0 to 100; higher score indicating worse health status/health related quality of life.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 24, 36, and 44
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 24, 36 and 44
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 12, 24, 36, and 52
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed consistent with the mechanism of action of reliever (30 minutes for albuterol or another short-acting beta agonists). Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36 and 52
Change From Baseline in Forced Expiratory Flow (FEF) 25 to 75 Percent (%) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52
FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the FEF at 25% to 75% of forced vital capacity (FVC), where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 44 and 52
Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period
Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
Time frame: Baseline (Day 1) to Week 52
Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbation Event During the 52-week Treatment Period
The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. Moderate exacerbations were recorded by the Investigator and defined as AECOPD event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Median time as well as 95% confidence interval was calculated using Kaplan-Meier estimates.
Time frame: Baseline (Day 1) and up to Weeks 12, 24, 36 and 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 98 days).
Time frame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology
Blood samples were collected to determine PCSA in hematology. PCSA values were defined as abnormal values considered medically important by the Sponsor according to pre-defined criteria/thresholds based on literature review and defined by the Sponsor for clinical laboratory tests. Criteria for PCSA: Hemoglobin (Hb): ≤115 grams per liter (g/L) (Male\[M\]); ≤95 g/L (Female\[F\]), ≥185 g/L (M); ≥165 g/L (F), Decrease from baseline ≥20 g/L; Hematocrit: ≤0.37 volume per volume (v/v) (M); ≤0.32 v/v (F), ≥0.55 v/v (M); ≥0.5 v/v (F); Erythrocyte Count: ≥6 Tera/L; Platelet count: \<100 Giga/L, ≥700 Giga/L; Leukocytes: \<3 Giga/L (Non-Black \[NB\]); \<2 Giga/L (Black \[B\]), ≥16 Giga/L; Neutrophils: \<1.5 Giga/L (NB); \<1 Giga/L (B); Lymphocytes: \>4 Giga/L; Monocytes: \>0.7 Giga/L; Basophils: \>0.1 Giga/L; Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN ≥0.5 Giga/L).
Time frame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry
Blood samples were collected to determine PCSA in chemistry. PCSA criteria: Sodium: ≤129 millimoles (mmol)/L, ≥160 mmol/L; Potassium: \<3 mmol/L, ≥5.5 mmol/L; Chloride: \<80 mmol/L, \>115 mmol/L; Glucose: ≤3.9 mmol/L and \<lower limit of normal (LLN), ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted);Total cholesterol: ≥7.74 mmol/L; Creatinine kinase: \>3 ULN, \>10 ULN; Creatinine: ≥150 micromoles (µmol)/L (adults), ≥30% change from baseline, ≥100% change from baseline, Creatinine Clearance (CG): ≥60 - \<90 milliliter per minute (mL/min), ≥30 - \<60 mL/min, ≥15 - \<30 mL/min, \<15 mL/min; Urea nitrogen: ≥17 mmol/L; Uric acid: \<120 μmol/L, \>408 μmol/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST): \>3 ULN, \>5 ULN, \>10 ULN; Alkaline phosphatase (ALP): \>1.5 ULN; Total bilirubin (TB): \>1.5 ULN, \>2 ULN; ALT and TB: ALT \>3 ULN and Bilirubin \> 2 ULN; Direct bilirubin (DB) and TB: DB \>35% Bilirubin and Bilirubin \>1.5 ULN; Albumin: ≤25 g/L.
Time frame: From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
Percentage of Participants With Abnormal Results for Urine Protein in Urinalysis
Urine dipstick samples were collected to determine the significant abnormalities in urine protein.
Time frame: Baseline (Day 1), Weeks 4, 8, 12, 24, 36, 52 and 64
Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab
Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity is defined as an ADA positive response in the assay at baseline with all post-treatment ADA results negative, or an ADA positive response at baseline with all post-treatment ADA responses less than 4-fold over baseline titer levels. Treatment-emergent response is defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. Treatment-boosted response is defined as an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.
Time frame: Up to Week 52
The study was conducted at 329 centers in 29 countries. A total of 2769 participants were screened between 06 July 2020 to 19 April 2023, of which 1834 participants were screen failures. Screen failures were mainly due to not meeting the eligibility criteria.
| Milestone | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Started | 465 | 470 |
| Randomized and treated | 465 | 468 |
| Safety population | 464 | 469 |
| Completed | 422 | 428 |
| Not completed | 43 | 42 |
| Withdrew: Adverse event | 7 | 14 |
| Withdrew: Poor compliance to protocol | 1 | 0 |
| Withdrew: Withdrawal by subject | 31 | 23 |
| Withdrew: Not related to coronavirus disease-2019 (covid-19) | 4 | 5 |
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
| Exacerbation per participant-year | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period | 1.295 (1.048 to 1.600) | 0.859 (0.699 to 1.057) |
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| Liters | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12 | 0.057 ± 0.017 | 0.139 ± 0.017 |
The SGRQ is a 50-item self-administered questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation and rated on electronic diary. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had a unique empirically derived weight where lowest possible weight was 0 and the highest was 100. Total score was obtained by summing all positive responses in the questionnaire. The total score and domain score was derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating worse health status/health related quality of life. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| score on a scale | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52 | -6.444 ± 0.922 | -9.816 ± 0.920 |
A responder was defined as a participant with improvement from baseline in SGRQ total score at Week 52 by ≥4 points. Percentage of participants who achieved a clinically meaningful response in SGRQ total score (improvement by ≥4 points)/responders are reported. SGRQ is a 50-item self-administered questionnaire. Scores by dimension were calculated for 3 domains: symptoms (respiratory symptoms: frequency and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response had unique empirically derived weight where lowest possible weight was 0 and highest was 100. Total score was obtained by summing all positive responses in questionnaire. Total score and domain score was derived from relevant items and converted to a score of 0 to 100; higher score indicating worse health status/health related quality of life.
| Percentage of participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Percentage of Participants With Saint George's Respiratory Questionnaire Improvement ≥4 Points at Week 52 | 46.5 | 51.4 |
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| Liters | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52 | 0.054 ± 0.020 | 0.115 ± 0.021 |
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| Liters | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Week 2 | 0.072 ± 0.018 | 0.108 ± 0.018 |
| Week 4 | 0.077 ± 0.018 | 0.132 ± 0.019 |
| Week 8 | 0.069 ± 0.019 | 0.133 ± 0.020 |
| Week 24 | 0.064 ± 0.020 | 0.154 ± 0.021 |
| Week 36 | 0.068 ± 0.021 | 0.117 ± 0.021 |
| Week 44 | 0.065 ± 0.020 | 0.154 ± 0.021 |
The FEV1 was the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometer. Post-bronchodilator FEV1 referred to the spirometry performed consistent with the mechanism of action of reliever (30 minutes for albuterol or another short-acting beta agonists). Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| Liters | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Week 2 | 0.082 ± 0.018 | 0.101 ± 0.018 |
| Week 4 | 0.098 ± 0.018 | 0.126 ± 0.018 |
| Week 8 | 0.083 ± 0.019 | 0.147 ± 0.020 |
| Week 12 | 0.064 ± 0.020 | 0.136 ± 0.020 |
| Week 24 | 0.081 ± 0.020 | 0.152 ± 0.020 |
| Week 36 | 0.070 ± 0.020 | 0.131 ± 0.021 |
| Week 52 | 0.059 ± 0.020 | 0.127 ± 0.021 |
FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the FEF at 25% to 75% of forced vital capacity (FVC), where FVC was defined as the volume of air that can be forcibly blown out after full inspiration in the upright position. Spirometry was performed after a wash out period of bronchodilators according to their action duration. Baseline was defined as the last available value up to randomization but prior to the first dose of study treatment.
| Liters per second | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Week 2 | 0.057 ± 0.018 | 0.103 ± 0.018 |
| Week 4 | 0.056 ± 0.018 | 0.114 ± 0.018 |
| Week 8 | 0.059 ± 0.019 | 0.134 ± 0.019 |
| Week 12 | 0.066 ± 0.021 | 0.137 ± 0.021 |
| Week 24 | 0.051 ± 0.019 | 0.147 ± 0.020 |
| Week 36 | 0.073 ± 0.021 | 0.128 ± 0.022 |
| Week 44 | 0.053 ± 0.021 | 0.154 ± 0.021 |
| Week 52 | 0.065 ± 0.020 | 0.122 ± 0.020 |
Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
| Exacerbation per participant-year | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period | 0.124 (0.072 to 0.215) | 0.070 (0.039 to 0.123) |
The time to first moderate or severe exacerbation was defined as date of the first event minus randomization date +1. Moderate exacerbations were recorded by the Investigator and defined as AECOPD event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Median time as well as 95% confidence interval was calculated using Kaplan-Meier estimates.
| Weeks | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Week 12 | 0.172 (0.139 to 0.207) | 0.108 (0.081 to 0.138) |
| Week 24 | 0.265 (0.225 to 0.306) | 0.206 (0.170 to 0.244) |
| Week 36 | 0.342 (0.298 to 0.387) | 0.292 (0.250 to 0.335) |
| Week 52 | 0.424 (0.375 to 0.471) | 0.361 (0.315 to 0.407) |
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed or worsened or became serious during TE period (between the first administration of study treatment to the last administration of the study treatment + 98 days).
| Participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Any TEAE | 330 | 322 |
| Any TESAE | 79 | 65 |
Blood samples were collected to determine PCSA in hematology. PCSA values were defined as abnormal values considered medically important by the Sponsor according to pre-defined criteria/thresholds based on literature review and defined by the Sponsor for clinical laboratory tests. Criteria for PCSA: Hemoglobin (Hb): ≤115 grams per liter (g/L) (Male\[M\]); ≤95 g/L (Female\[F\]), ≥185 g/L (M); ≥165 g/L (F), Decrease from baseline ≥20 g/L; Hematocrit: ≤0.37 volume per volume (v/v) (M); ≤0.32 v/v (F), ≥0.55 v/v (M); ≥0.5 v/v (F); Erythrocyte Count: ≥6 Tera/L; Platelet count: \<100 Giga/L, ≥700 Giga/L; Leukocytes: \<3 Giga/L (Non-Black \[NB\]); \<2 Giga/L (Black \[B\]), ≥16 Giga/L; Neutrophils: \<1.5 Giga/L (NB); \<1 Giga/L (B); Lymphocytes: \>4 Giga/L; Monocytes: \>0.7 Giga/L; Basophils: \>0.1 Giga/L; Eosinophils: \>0.5 Giga/L or \>upper limit of normal (ULN) (if ULN ≥0.5 Giga/L).
| Percentage of participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Hb: ≤115 g/ L (M); ≤95 g/ L (F) | 6.1 | 5.0 |
| Hb: ≥185 g/L (M); ≥165 g/L (F) | 3.7 | 4.7 |
| Hb: Decrease from baseline ≥20 g/L | 9.8 | 11.4 |
| Hematocrit: ≤0.37 v/v (M); ≤0.32 v/v (F) | 6.1 | 5.0 |
| Hematocrit: ≥0.55 v/v (M); ≥0.5 v/v (F) | 23.1 | 26.5 |
| Erythrocyte Count: ≥6 Tera/L | 4.4 | 6.0 |
| Platelet count: <100 Giga/L | 0.2 | 0.6 |
| Platelet count: ≥700 Giga/L | 0.7 | 0.4 |
| Leukocytes: <3 Giga/L (NB); <2 Giga/L (B) | 0.7 | 0.6 |
| Leukocytes: ≥16 Giga/L | 5.2 | 4.1 |
| Neutrophils: <1.5 Giga/L (NB); <1 Giga/L (B) | 2.7 | 1.5 |
| Lymphocytes: >4 Giga/L | 5.9 | 8.2 |
| Monocytes: >0.7 Giga/L | 65.8 | 64.9 |
| Basophils: >0.1 Giga/L | 28.1 | 29.5 |
| Eosinophils: >0.5 Giga/L or >ULN | 15.3 | 21.1 |
Blood samples were collected to determine PCSA in chemistry. PCSA criteria: Sodium: ≤129 millimoles (mmol)/L, ≥160 mmol/L; Potassium: \<3 mmol/L, ≥5.5 mmol/L; Chloride: \<80 mmol/L, \>115 mmol/L; Glucose: ≤3.9 mmol/L and \<lower limit of normal (LLN), ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted);Total cholesterol: ≥7.74 mmol/L; Creatinine kinase: \>3 ULN, \>10 ULN; Creatinine: ≥150 micromoles (µmol)/L (adults), ≥30% change from baseline, ≥100% change from baseline, Creatinine Clearance (CG): ≥60 - \<90 milliliter per minute (mL/min), ≥30 - \<60 mL/min, ≥15 - \<30 mL/min, \<15 mL/min; Urea nitrogen: ≥17 mmol/L; Uric acid: \<120 μmol/L, \>408 μmol/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST): \>3 ULN, \>5 ULN, \>10 ULN; Alkaline phosphatase (ALP): \>1.5 ULN; Total bilirubin (TB): \>1.5 ULN, \>2 ULN; ALT and TB: ALT \>3 ULN and Bilirubin \> 2 ULN; Direct bilirubin (DB) and TB: DB \>35% Bilirubin and Bilirubin \>1.5 ULN; Albumin: ≤25 g/L.
| Percentage of participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Sodium: ≤129 mmol/L | 1.7 | 1.9 |
| Sodium: ≥160 mmol/L | 0 | 0.2 |
| Potassium: <3 mmol/L | 0.4 | 0.4 |
| Potassium: ≥5.5 mmol/L | 11.3 | 10.8 |
| Chloride: <80 mmol/L | 0 | 0.2 |
| Chloride: >115 mmol/L | 0 | 0.2 |
| Glucose: ≤3.9 mmol/L and <LLN | 7.0 | 6.5 |
| Glucose: ≥11.1 mmol/L (unfasted); ≥7 mmol/L (fasted) | 7.6 | 8.8 |
| Total cholesterol: ≥7.74 mmol/L | 6.1 | 4.3 |
| Creatinine kinase: >3 ULN | 2.2 | 3.9 |
| Creatinine kinase: >10 ULN | 0 | 0 |
| Creatinine: ≥150 µmol/L | 2.6 | 3.0 |
| Creatinine: ≥30% change from baseline | 20.3 | 19.2 |
| Creatinine: ≥100% change from baseline | 0.7 | 2.4 |
| CG: ≥60 - <90 mL/min | 36.4 | 39.0 |
| CG: ≥30 - <60 mL/min | 18.5 | 16.8 |
| CG: ≥15 - <30 mL/min | 0 | 0.9 |
| CG: <15 mL/min | 0.2 | 0.4 |
| Urea nitrogen: ≥17 mmol/L | 0.2 | 0.4 |
| Uric acid: <120 μmol/L | 0 | 0.4 |
| Uric acid: >408 μmol/L | 37.7 | 39.7 |
| ALT: >3 ULN | 1.5 | 0.4 |
| ALT: >5 ULN | 0.2 | 0 |
| ALT: >10 ULN | 0 | 0 |
| AST: >3 ULN | 0.2 | 0.4 |
| AST: >5 ULN | 0 | 0.2 |
| AST: >10 ULN | 0 | 0 |
| ALP: >1.5 ULN | 3.9 | 2.8 |
| TB: >1.5 ULN | 0.9 | 2.2 |
| TB: >2 ULN | 0.2 | 0 |
| ALT and TB: ALT >3 ULN and Bilirubin > 2 ULN | 0.2 | 0 |
| DB and TB: DB >35% Bilirubin and Bilirubin >1.5 ULN | 4.5 | 5.6 |
| Albumin: ≤25 g/L | 0.2 | 0.4 |
Urine dipstick samples were collected to determine the significant abnormalities in urine protein.
| Percentage of participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Baseline (Day 1) | 5.0 | 6.2 |
| Week 4 | 4.1 | 4.9 |
| Week 8 | 3.7 | 5.3 |
| Week 12 | 4.5 | 6.4 |
| Week 24 | 3.9 | 4.5 |
| Week 36 | 3.9 | 4.5 |
| Week 52 | 5.0 | 6.6 |
| Week 64 | 4.5 | 5.5 |
Plasma samples were collected to evaluate antibodies to dupilumab. Pre-existing immunoreactivity is defined as an ADA positive response in the assay at baseline with all post-treatment ADA results negative, or an ADA positive response at baseline with all post-treatment ADA responses less than 4-fold over baseline titer levels. Treatment-emergent response is defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. Treatment-boosted response is defined as an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.
| Participants | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Pre-existing immunoreactivity | 6 | 4 |
| Treatment-emergent ADA response | 11 | 47 |
| Treatment-boosted ADA response | 0 | 1 |
Collected over AEs, SAEs, all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 8/464 (1.7%) | 79/464 (17%) | 120/464 (25.9%) |
| Dupilumab 300 mg q2w | 14/469 (3%) | 65/469 (13.9%) | 125/469 (26.7%) |
| Event | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 40/464 | 25/469 |
| PneumoniaInfections and infestations | 5/464 | 9/469 |
| Covid-19 PneumoniaInfections and infestations | 2/464 | 6/469 |
| Covid-19Infections and infestations | 5/464 | 3/469 |
| Pneumonia BacterialInfections and infestations | 2/464 | 2/469 |
| Pneumonia PseudomonalInfections and infestations | 2/464 | 0/469 |
| Ischaemic StrokeNervous system disorders | 2/464 | 0/469 |
| Acute Myocardial InfarctionCardiac disorders | 2/464 | 0/469 |
| Angina UnstableCardiac disorders | 2/464 | 0/469 |
| Cardiac Failure CongestiveCardiac disorders | 2/464 | 2/469 |
| Event | Placebo | Dupilumab 300 mg q2w |
|---|---|---|
| Covid-19Infections and infestations | 36/464 | 45/469 |
| HeadacheNervous system disorders | 29/464 | 37/469 |
| Accidental OverdoseInjury, poisoning and procedural complications | 33/464 | 31/469 |
| NasopharyngitisInfections and infestations | 28/464 | 32/469 |
The Randomized population included all participants who had been allocated to a randomized treatment regardless of whether the treatment kit was used.
| Age, Continuous(Years) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| Mean | 64.9 ± 8.5 | 65.2 ± 8.1 | 65.0 ± 8.3 |
| Sex: Female, Male(Participants) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| Female | 153 | 150 | 303 |
| Male | 312 | 320 | 632 |
| Race (NIH/OMB)(Participants) | Placebo | Dupilumab 300 mg q2w | Total |
|---|---|---|---|
| American Indian or Alaska Native | 26 | 22 | 48 |
| Asian | 3 | 7 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 8 | 4 | 12 |
| White | 416 | 422 | 838 |
| More than one race | 8 | 12 | 20 |
| Unknown or Not Reported | 4 | 2 | 6 |
Showing the first 100 of 334 sites across 29 countries.
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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