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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04456673
Registration number
NCT04456673
Ethics application status
Date submitted
30/06/2020
Date registered
2/07/2020
Date last updated
29/05/2025
Titles & IDs
Public title
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
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Secondary ID [1]
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U1111-1211-8837
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Secondary ID [2]
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EFC15805
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Universal Trial Number (UTN)
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Trial acronym
NOTUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab SAR231893
Treatment: Drugs - Inhaled Corticosteroid
Treatment: Drugs - Inhaled Long-Acting Beta Agonist
Treatment: Drugs - Inhaled Long-Acting Muscarinic Antagonist
Treatment: Drugs - Placebo
Experimental: Dupilumab - Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks
Placebo comparator: Placebo - Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks
Treatment: Drugs: Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Treatment: Drugs: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Treatment: Drugs: Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Treatment: Drugs: Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation
Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) to Week 52
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Secondary outcome [1]
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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) to Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) and Week 12
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Secondary outcome [2]
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Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score to Week 52
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 1) and Week 52
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Secondary outcome [3]
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Percentage of Participants With Saint George's Respiratory Questionnaire Improvement =4 Points at Week 52
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 1) and Week 52
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Secondary outcome [4]
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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Week 52
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Day 1) and Week 52
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Secondary outcome [5]
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Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 24, 36, and 44
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline (Day 1) and Weeks 2, 4, 8, 24, 36 and 44
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Secondary outcome [6]
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Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second to Weeks 2, 4, 8, 12, 24, 36, and 52
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36 and 52
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Secondary outcome [7]
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Change From Baseline in Forced Expiratory Flow (FEF) 25 to 75 Percent (%) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (Day 1) and Weeks 2, 4, 8, 12, 24, 36, 44 and 52
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Secondary outcome [8]
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Annualized Rate of Severe Chronic Obstructive Pulmonary Disease Exacerbations Over the 52-week Treatment Period
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline (Day 1) to Week 52
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Secondary outcome [9]
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Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease Exacerbation Event During the 52-week Treatment Period
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (Day 1) and up to Weeks 12, 24, 36 and 52
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Secondary outcome [10]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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Assessment method [10]
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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).
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Timepoint [10]
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From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
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Secondary outcome [11]
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Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology
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Assessment method [11]
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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).
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Timepoint [11]
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From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
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Secondary outcome [12]
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Percentage of Participants With Potentially Clinically Significant Abnormalities in Clinical Chemistry
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Assessment method [12]
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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 \
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.
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Timepoint [12]
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From the first dose of study treatment (Day 1) up to the last dose of the study treatment + 98 days, up to 506 days
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Secondary outcome [13]
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Percentage of Participants With Abnormal Results for Urine Protein in Urinalysis
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Assessment method [13]
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Urine dipstick samples were collected to determine the significant abnormalities in urine protein.
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Timepoint [13]
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Baseline (Day 1), Weeks 4, 8, 12, 24, 36, 52 and 64
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Secondary outcome [14]
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Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab
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Assessment method [14]
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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.
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Timepoint [14]
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Up to Week 52
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Eligibility
Key inclusion criteria
* Participants with a physician diagnosis of COPD who met the following criteria at screening:
* Current or former smokers with a smoking history of =10 pack-years.
* Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and =70%).
* Medical Research Council (MRC) Dyspnea Scale grade =2.
* Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.
* Documented history of high exacerbation risk defined as exacerbation history of =2 moderate or =1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were recorded by the investigator and defined as AECOPD requiring hospitalization or observation > 24 hours in emergency department/urgent care facility.
* Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for =1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
* Evidence of Type 2 inflammation: Participants with blood eosinophils =300 cells/microliter at Visit 1.
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Minimum age
40
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* COPD diagnosis for less than 12 months prior to randomization.
* Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
* Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
* Cor pulmonale, evidence of right cardiac failure.
* Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%
* Hypercapnia requiring Bi-level ventilation.
* AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.
* Respiratory tract infection within 4 weeks prior to screening, or during the screening period.
* History of, or planned pneumonectomy or lung volume reduction surgery. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
* Diagnosis of a-1 anti-trypsin deficiency.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/05/2024
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Sample size
Target
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Accrual to date
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Final
935
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Investigational Site Number : 0360008 - Kent Town
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Recruitment hospital [2]
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Investigational Site Number : 0360005 - Clayton
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Recruitment hospital [3]
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Investigational Site Number : 0360001 - Spearwood
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Recruitment postcode(s) [1]
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5067 - Kent Town
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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6163 - Spearwood
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Buenos Aires
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Ciudad De Buenos Aires
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Ruse
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Sofia
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Stara Zagora
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Vidin
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Chippenham
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Derby
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Regeneron Pharmaceuticals
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Ethics approval
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Summary
Brief summary
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 * Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo * Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) * Pre-bronchodilator FEV1 over 52 weeks compared to placebo * Lung function assessments * Moderate and severe COPD exacerbations * To evaluate safety and tolerability * To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)
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Trial website
https://clinicaltrials.gov/study/NCT04456673
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Contacts
Principal investigator
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0
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Clinical Sciences & Operations
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Sanofi
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Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/73/NCT04456673/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/73/NCT04456673/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04456673
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