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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001953-28 | EudraCT Number | ||
| U1111-1211-8804 | Other Identifier | UTN |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
|
| Placebo | Placebo Comparator | Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment [EOT] visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab SAR231893 | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | Baseline (Day 1) to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 12 | The FEV1 was 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 (Day 1) to Week 12 |
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Inclusion criteria:
Participants with a physician diagnosis of COPD who met the following criteria at screening:
Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEC Clinical Research, LLC-Site Number:8400030 | Andalusia | Alabama | 36420 | United States | ||
| Clinical Research Center of Alabama, LLC-Site Number:8400041 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42337097 | Derived | Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Walsh L, Winders T, Bansal A, Robinson LB. Summary of Research: Dupilumab for Chronic Obstructive Pulmonary Disease with Type 2 Inflammation: A Pooled Analysis of Two Phase 3, Randomised, Double-Blind, Placebo-Controlled Trials. Pulm Ther. 2026 Jun 23. doi: 10.1007/s41030-026-00361-2. Online ahead of print. | |
| 41794122 |
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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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A total of 939 participants were randomized in a 1:1 ratio to receive either dupilumab 300 milligrams (mg) every 2 weeks (q2w) or matching placebo for 52 weeks.
The study was conducted at 275 centers in 24 countries. A total of 2599 participants were screened from 15 Apr 2019 to 12 Jan 2022, of which 1660 were screen failures due to not meeting eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment [EOT] visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
| FG001 | Dupilumab 300 mg q2w |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 7, 2018 | Jan 30, 2024 |
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| Inhaled Corticosteroid | Drug | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
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| Inhaled Long-Acting Beta Agonist | Drug | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
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| Inhaled Long-Acting Muscarinic Antagonist | Drug | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
|
| Placebo | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Change From Baseline in Pre-BD FEV1 at Week 52 | The FEV1 was 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 (Day 1) to Week 52 |
| Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb) | FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second (mL/s) and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour. | Baseline (Day 1) to Week 12 |
| Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb | FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour. | Baseline (Day 1) to Week 52 |
| Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | The SGRQ was 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, activity and impacts (psycho-social) as well as a total score. Global and domain scores range from 0 to 100, with 100 representing the worst possible health status and 0 indicating the best possible health status. Higher score indicates worse health status/heath related quality of life. | Baseline (Day 1) to Week 52 |
| Percentage of Participants With SGRQ 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. Participants with improvement <4 points or with missing values were considered as non-responders. The percentage of participants who achieved a clinically meaningful response in SGRQ total score (reduction [improvement] by >=4 points)/responders are reported. | Baseline (Day 1) to Week 52 |
| Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52 | The E-RS in COPD scale was a part of the exacerbations of chronic pulmonary disease tool (EXACT). It was a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. E-RS: COPD RS-Total Score was derived based on weekly averages of daily assessed 11 respiratory symptom items contained in the 14-item EXACT questionnaire. The RS-Total score represented overall respiratory symptom severity, ranged from 0 to 40. Summation procedure was used to derive the three daily domain scores: 1). RS-Breathlessness (range 0-17), 2) RS-Cough and Sputum (score range 0-11), 3) RS-Chest Symptoms (score range 0-12). The higher the score, more severe were the symptoms. | Baseline (Day 1) to Week 52 |
| Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb | Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 among participants with baseline FeNO >=20 ppb was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | Baseline (Day 1) to Week 52 |
| Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44 | The FEV1 was 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 (Day 1) to Weeks 2, 4, 8, 24, 36 and 44 |
| Change From Baseline in Post-BD FEV1 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-BD FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator. | Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52 |
| Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52 | FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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 (Day 1) to Weeks 2, 4, 8, 12, 24, 36, 44 and 52 |
| Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52 | FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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 (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52 |
| Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period | Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | Baseline (Day 1) to Week 52 |
| Time to First Moderate or Severe COPD Exacerbation 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. The median time to first severe exacerbation was derived from Cox regression model. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. | 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 Adverse Event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TE period which was defined as the period from the time of first dose of study treatment until the last visit in the study. Serious adverse events (SAE) were 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 or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. | TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days |
| Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab | Number of participants with treatment-emergent response to dupilumab with peak post-baseline titers during the on-treatment period are reported. Treatment-emergent response was defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Categories were based on titer values and included: low (Titer <1000); moderate (1000<=Titer<=10,000); and high (Titer >10,000). On-treatment period was defined as last study treatment administration plus 14 days; that is, Week 52. | Up to Week 52 |
| Birmingham |
| Alabama |
| 35209-6802 |
| United States |
| UAB Lung Health Center-Site Number:8400013 | Birmingham | Alabama | 35294 | United States |
| SEC Clinical Research, LLC-Site Number:8400059 | Dothan | Alabama | 36303 | United States |
| Pulmonary Associates of Mobile, P.C.-Site Number:8400057 | Mobile | Alabama | 36608 | United States |
| Asthma and Allergy Associates, PC-Site Number:8400034 | Colorado Springs | Colorado | 80907 | United States |
| Clinical Research Of West Florida Inc-Site Number:8400010 | Clearwater | Florida | 33765 | United States |
| Finlay Medical Research-Site Number:8400014 | Greenacres City | Florida | 33467 | United States |
| Project 4 research, Inc.-Site Number:8400023 | Miami | Florida | 33125 | United States |
| Finlay Medical Research-Site Number:8400062 | Miami | Florida | 33126 | United States |
| Renstar Medical Research-Site Number:8400051 | Ocala | Florida | 34470 | United States |
| Florida Institute for Clinical Research, LLC-Site Number:8400029 | Orlando | Florida | 32825 | United States |
| Emerald Coast Research Associates-Site Number:8400032 | Panama City | Florida | 32405 | United States |
| Sarasota Clinical Research-Site Number:8400026 | Sarasota | Florida | 34239 | United States |
| VitaLink research-Hamilton Mill-Site Number:8400055 | Dacula | Georgia | 30019 | United States |
| DC Research Works-Site Number:8400016 | Marietta | Georgia | 30060 | United States |
| North Georgia Clinical Research-Site Number:8400025 | Woodstock | Georgia | 30189 | United States |
| Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012 | Baltimore | Maryland | 21224 | United States |
| Asthma Allergy & Sinus Center-Site Number:8400038 | White Marsh | Maryland | 21162 | United States |
| Michigan Medicine (University of Michigan)-Site Number:8400050 | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Lanmark Center 2-46-Site Number:8400065 | Rochester | Minnesota | 55905 | United States |
| Midwest Chest Consultants, P.C.-Site Number:8400011 | Saint Charles | Missouri | 63301 | United States |
| Washington University School of Medicine-Site Number:8400004 | St Louis | Missouri | 63104 | United States |
| Sierra Clinical Research-Site Number:8400035 | Las Vegas | Nevada | 89106 | United States |
| Va Western New York Healthcare-Site Number:8400067 | Buffalo | New York | 14215 | United States |
| IMA Clinical Research, LLC-Site Number:8400070 | New York | New York | 10036 | United States |
| The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019 | Chapel Hill | North Carolina | 27514 | United States |
| American Health Research-Site Number:8400061 | Charlotte | North Carolina | 28277 | United States |
| Duke Asthma, Allergy and Airway Center-Site Number:8400064 | Durham | North Carolina | 27705 | United States |
| Accellacare-Site Number:8400052 | Wilmington | North Carolina | 28401 | United States |
| Southeastern Research Center-Site Number:8400060 | Winston-Salem | North Carolina | 27103-4027 | United States |
| Midwest Pulmonary and Sleep Research Center-Site Number:8400040 | Dayton | Ohio | 45459 | United States |
| Aventiv Research, Inc-Site Number:8400024 | Dublin | Ohio | 43016 | United States |
| OK Clinical Research-Site Number:8400005 | Edmond | Oklahoma | 73034 | United States |
| Velocity Clinical Research, Medford-Site Number:8400001 | Medford | Oregon | 97504 | United States |
| Jefferson Associates in Internal Medicine-Site Number:8400037 | Clairton | Pennsylvania | 15025 | United States |
| Temple University Hospital-Site Number:8400009 | Philadelphia | Pennsylvania | 19140 | United States |
| Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033 | Pittsburgh | Pennsylvania | 15213 | United States |
| Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063 | Wyomissing | Pennsylvania | 19610 | United States |
| VitaLink Research-Easley-Site Number:8400022 | Easley | South Carolina | 29640 | United States |
| VitaLink Research- Gaffney-Site Number:8400047 | Gaffney | South Carolina | 29340 | United States |
| VitaLink Research-Greenville-Site Number:8400007 | Greenville | South Carolina | 29615 | United States |
| Clinical Research of Charleston-Site Number:8400044 | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Research of Rock Hill-Site Number:8400046 | Rock Hill | South Carolina | 29732 | United States |
| VitaLink Research - Spartanburg-Site Number:8400048 | Spartanburg | South Carolina | 29303 | United States |
| Clinical Trials Center of Middle Tennessee-Site Number:8400073 | Franklin | Tennessee | 37067 | United States |
| Bayer College of Medicine-Site Number:8400018 | Houston | Texas | 77030 | United States |
| Metroplex Pulmonary and Sleep Center-Site Number:8400021 | McKinney | Texas | 75069 | United States |
| Sherman Clinical Research-Site Number:8400027 | Sherman | Texas | 75092 | United States |
| MultiCare Institute for Research and Innovation-Site Number:8400036 | Tacoma | Washington | 98405 | United States |
| Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008 | Greenfield | Wisconsin | 53228 | United States |
| Investigational Site Number :0320011 | CABA | Buenos Aires | 1430 | Argentina |
| Investigational Site Number :0320002 | CABA | Buenos Aires | C1414AIF | Argentina |
| Investigational Site Number :0320003 | CABA | Buenos Aires | C1425BEN | Argentina |
| Investigational Site Number :0320004 | CABA | Buenos Aires | C1425FVH | Argentina |
| Investigational Site Number :0320012 | La Plata | Buenos Aires | B1900BNN | Argentina |
| Investigational Site Number :0320007 | Quilmes | Buenos Aires F.D. | B1878FNR | Argentina |
| Investigational Site Number :0320006 | Rosario | Santa Fe Province | S2000DBS | Argentina |
| Investigational Site Number :0320009 | San Miguel de Tucumán | Tucumán Province | T4000IAR | Argentina |
| Investigational Site Number :0320001 | Buenos Aires | C1121ABE | Argentina |
| Investigational Site Number :0320005 | Buenos Aires | Argentina |
| Investigational Site Number :0320008 | Mar del Plata | B7600 | Argentina |
| Investigational Site Number :0320010 | Mendoza | 5500 | Argentina |
| Investigational Site Number :1001004 | Haskovo | 6305 | Bulgaria |
| Investigational Site Number :1001003 | Montana | 3400 | Bulgaria |
| Investigational Site Number :1001006 | Rousse | 7002 | Bulgaria |
| Investigational Site Number :1001009 | Sofia | 1202 | Bulgaria |
| Investigational Site Number :1001002 | Sofia | 1233 | Bulgaria |
| Investigational Site Number :1001001 | Sofia | 1680 | Bulgaria |
| Investigational Site Number :1001005 | Stara Zagora | 6001 | Bulgaria |
| Investigational Site Number :1001010 | Troyan Municipality | 5600 | Bulgaria |
| Investigational Site Number :1240021 | Edmonton | Alberta | T5H4B9 | Canada |
| Investigational Site Number :1240015 | Edmonton | Alberta | T6G 2G3 | Canada |
| Investigational Site Number :1240016 | Sherwood Park | Alberta | T8H 0N2 | Canada |
| Investigational Site Number :1240017 | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Investigational Site Number :1240007 | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Investigational Site Number :1240002 | Burlington | Ontario | L7N 3V2 | Canada |
| Investigational Site Number :1240012 | Toronto | Ontario | M5T 3A9 | Canada |
| Investigational Site Number :1240013 | Windsor | Ontario | N8X 5A6 | Canada |
| Investigational Site Number :1240009 | Montreal | Quebec | H1M 1B1 | Canada |
| Investigational Site Number :1240003 | Montreal | Quebec | H1T 1C8 | Canada |
| Investigational Site Number :1240001 | Montreal | Quebec | H4A 3J1 | Canada |
| Investigational Site Number :1240010 | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Investigational Site Number :1240011 | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Investigational Site Number :1240006 | St-charles Borrommee | Quebec | J6E 2B4 | Canada |
| Investigational Site Number :1240008 | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Investigational Site Number :1240020 | Victoriaville | Quebec | G6P 6P6 | Canada |
| Investigational Site Number :1240005 | Québec | G1V 4G5 | Canada |
| Investigational Site Number :1240004 | Québec | G1V 4W2 | Canada |
| Investigational Site Number :1240019 | Québec | G3K 2P8 | Canada |
| Investigational Site Number :1240018 | Québec | GIS 2L6 | Canada |
| Investigational Site Number :1520006 | Curicó | Maule Region | 3341643 | Chile |
| Investigational Site Number :1520001 | Talca | Maule Region | Chile |
| Investigational Site Number :1520009 | Santiago | Reg Metropolitana de Santiago | 7500587 | Chile |
| Investigational Site Number :1520003 | Santiago | Reg Metropolitana de Santiago | 7500692 | Chile |
| Investigational Site Number :1520005 | Santiago | Reg Metropolitana de Santiago | 7500698 | Chile |
| Investigational Site Number :1520008 | Santiago | Reg Metropolitana de Santiago | 8380453 | Chile |
| Investigational Site Number :1520002 | Santiago | Reg Metropolitana de Santiago | 8910131 | Chile |
| Investigational Site Number :1520004 | Quillota | Valparaiso | 2260877 | Chile |
| Investigational Site Number :1560037 | Baotou | 014010 | China |
| Investigational Site Number :1560006 | Beijing | China |
| Investigational Site Number :1560003 | Changchun | 130021 | China |
| Investigational Site Number :1560022 | Changsha | 410011 | China |
| Investigational Site Number :1560021 | Changsha | 410013 | China |
| Investigational Site Number :1560001 | Chengdu | 610041 | China |
| Investigational Site Number :1560017 | Chengdu | 611130 | China |
| Investigational Site Number :1560012 | Chongqing | 400037 | China |
| Investigational Site Number :1560005 | Chongqing | 400038 | China |
| Investigational Site Number :1560053 | Fuzhou | 350001 | China |
| Investigational Site Number :1560036 | Guangzhou | 510150 | China |
| Investigational Site Number :1560019 | Guangzhou | 510163 | China |
| Investigational Site Number :1560045 | Haikou | 570216 | China |
| Investigational Site Number :1560018 | Haikou | 570311 | China |
| Investigational Site Number :1560046 | Hangzhou | 310009 | China |
| Investigational Site Number :1560009 | Hefei | 230022 | China |
| Investigational Site Number :1560041 | Hefei | China |
| Investigational Site Number :1560015 | Hohhot | 010017 | China |
| Investigational Site Number :1560008 | Hohhot | 010050 | China |
| Investigational Site Number :1560027 | Nanchang | 330006 | China |
| Investigational Site Number :1560034 | Nanjing | 210009 | China |
| Investigational Site Number :1560032 | Shanghai | 200025 | China |
| Investigational Site Number :1560013 | Shanghai | 200080 | China |
| Investigational Site Number :1560007 | Shanghai | 200433 | China |
| Investigational Site Number :1560014 | Shenyang | 110001 | China |
| Investigational Site Number :1560004 | Shenyang | 110004 | China |
| Investigational Site Number :1560051 | Shenzhen | 518020 | China |
| Investigational Site Number :1560016 | Shijiazhuang | 050000 | China |
| Investigational Site Number :1560024 | Taiyuan | 030001 | China |
| Investigational Site Number :1560010 | Tianjin | 300052 | China |
| Investigational Site Number :1560028 | Ürümqi | 830054 | China |
| Investigational Site Number :1560052 | Wuhan | 430014 | China |
| Investigational Site Number :1560020 | Xi'an | 710061 | China |
| Investigational Site Number :1560054 | Xuzhou | 221002 | China |
| Investigational Site Number :1560011 | Yangzhou | 225001 | China |
| Investigational Site Number :1560031 | Zhanjiang | 524001 | China |
| Investigational Site Number :1560002 | Zhengzhou | 450003 | China |
| Investigational Site Number :2030002 | Jindrichuv Hradec III | 37701 | Czechia |
| Investigational Site Number :2030005 | Karlovy Vary | 36017 | Czechia |
| Investigational Site Number :2030009 | Miroslav | 67172 | Czechia |
| Investigational Site Number :2030001 | Nový Bor | 47301 | Czechia |
| Investigational Site Number :2030003 | Prague | 14059 | Czechia |
| Investigational Site Number :2030008 | Praha 6 - Brevnov | 16900 | Czechia |
| Investigational Site Number :2030004 | Rokycany | 33722 | Czechia |
| Investigational Site Number :2030006 | Strakonice | 38601 | Czechia |
| Investigational Site Number :2080003 | Aalborg | 9100 | Denmark |
| Investigational Site Number :2080001 | Copenhagen Nv | 2400 | Denmark |
| Investigational Site Number :2080002 | Hvidovre | 2650 | Denmark |
| Investigational Site Number :2080006 | Næstved | 4700 | Denmark |
| Investigational Site Number :2080005 | Odense C | 5000 | Denmark |
| Investigational Site Number :2080004 | Roskilde | 4000 | Denmark |
| Investigational Site Number :2080007 | Vejle | 7100 | Denmark |
| Investigational Site Number :2460003 | Pori | 28500 | Finland |
| Investigational Site Number :2460001 | Turku | 20520 | Finland |
| Investigational Site Number :2760006 | Berlin | 10787 | Germany |
| Investigational Site Number :2760009 | Frankfurt am Main | 60596 | Germany |
| Investigational Site Number :2760002 | Hamburg | 20354 | Germany |
| Investigational Site Number :2760007 | Koblenz | 56068 | Germany |
| Investigational Site Number :2760011 | Leipzig | 04347 | Germany |
| Investigational Site Number :2760010 | Lübeck | 23552 | Germany |
| Investigational Site Number :2760008 | Marburg | 35043 | Germany |
| Investigational Site Number :3480007 | Balassagyarmat | 2660 | Hungary |
| Investigational Site Number :3480011 | Budapest | 1122 | Hungary |
| Investigational Site Number :3480008 | Edelény | 3780 | Hungary |
| Investigational Site Number :3480001 | Gödöllö | 2100 | Hungary |
| Investigational Site Number :3480010 | Hajdunánás | 4080 | Hungary |
| Investigational Site Number :3480002 | Komárom | 2900 | Hungary |
| Investigational Site Number :3480003 | Makó | 6900 | Hungary |
| Investigational Site Number :3480006 | Mohács | 7700 | Hungary |
| Investigational Site Number :3480012 | Püspökladány | 4150 | Hungary |
| Investigational Site Number :3480004 | Százhalombatta | 2440 | Hungary |
| Investigational Site Number :3480005 | Szombathely | 9700 | Hungary |
| Investigational Site Number :3760006 | Ashkelon | 78278 | Israel |
| Investigational Site Number :3760007 | Beersheba | 84101 | Israel |
| Investigational Site Number :3760003 | Haifa | 34362 | Israel |
| Investigational Site Number :3760005 | Jerusalem | 91031 | Israel |
| Investigational Site Number :3760004 | Jerusalem | 91120 | Israel |
| Investigational Site Number :3760001 | Petah Tikva | 49100 | Israel |
| Investigational Site Number :3760002 | Rehovot | 76100 | Israel |
| Investigational Site Number :3800004 | Cona | Ferrara | 44124 | Italy |
| Investigational Site Number :3800003 | Rozzano | Milano | 20089 | Italy |
| Investigational Site Number :3800007 | Pisa | 56124 | Italy |
| Investigational Site Number :3800001 | Reggio Emilia | 42123 | Italy |
| Investigational Site Number :3800005 | Roma | 00133 | Italy |
| Investigational Site Number :3920013 | Kasuga-shi | Fukuoka | 816-0813 | Japan |
| Investigational Site Number :3920011 | Himeji-shi | Hyōgo | 670-0849 | Japan |
| Investigational Site Number :3920023 | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| Investigational Site Number :3920014 | Naka-gun | Ibaraki | 319-1113 | Japan |
| Investigational Site Number :3920019 | Takamatsu | Kagawa-ken | 761-8073 | Japan |
| Investigational Site Number :3920027 | Yokohama | Kanagawa | 223-0059 | Japan |
| Investigational Site Number :3920003 | Joyo-shi | Kyoto | 610-0113 | Japan |
| Investigational Site Number :3920017 | Kyoto | Kyoto | 612-8555 | Japan |
| Investigational Site Number :3920006 | Ueda-shi | Nagano | Japan |
| Investigational Site Number :3920029 | Urasoe-shi | Okinawa | 901-2121 | Japan |
| Investigational Site Number :3920018 | Kawachinagano-shi | Osaka | 586-8521 | Japan |
| Investigational Site Number :3920001 | Kishiwada-shi | Osaka | 596-8501 | Japan |
| Investigational Site Number :3920028 | Osaka | Osaka | 531-0073 | Japan |
| Investigational Site Number :3920012 | Sakai-shi | Osaka | 591-8555 | Japan |
| Investigational Site Number :3920021 | Hamamatsu | Shizuoka | 434-8511 | Japan |
| Investigational Site Number :3920008 | Chuo-ku | Tokyo | 103-0022 | Japan |
| Investigational Site Number :3920030 | Chuo-ku | Tokyo | 103-0028 | Japan |
| Investigational Site Number :3920005 | Chuo-ku | Tokyo | 104-0031 | Japan |
| Investigational Site Number :3920015 | Kokubunji-shi | Tokyo | 185-0014 | Japan |
| Investigational Site Number :3920016 | Shinagawa-ku | Tokyo | 140-8522 | Japan |
| Investigational Site Number :3920004 | Toshima-ku | Tokyo | 170-0003 | Japan |
| Investigational Site Number :3920026 | Toshima-ku | Tokyo | 1710014 | Japan |
| Investigational Site Number :4840002 | Guadalajara | Jalisco | 44100 | Mexico |
| Investigational Site Number :4840001 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number :4840004 | Chihuahua City | 31000 | Mexico |
| Investigational Site Number :4840003 | Durango | 34080 | Mexico |
| Investigational Site Number :4840006 | Mexico City | 06700 | Mexico |
| Investigational Site Number :4840007 | Oaxaca City | 68000 | Mexico |
| Investigational Site Number :4840005 | Veracruz | 91910 | Mexico |
| Investigational Site Number :6160016 | Poznan | Greater Poland Voivodeship | 60-214 | Poland |
| Investigational Site Number :6160006 | Poznan | Greater Poland Voivodeship | 61-578 | Poland |
| Investigational Site Number :6160009 | Grudziądz | Kuyavian-Pomeranian Voivodeship | 86-300 | Poland |
| Investigational Site Number :6160007 | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Investigational Site Number :6160015 | Grodzisk Mazowiecki | Masovian Voivodeship | 05-825 | Poland |
| Investigational Site Number :6160012 | Warsaw | Masovian Voivodeship | 01-456 | Poland |
| Investigational Site Number :6160008 | Bialystok | Podlaskie Voivodeship | 15-044 | Poland |
| Investigational Site Number :6160014 | Elblag | Pomeranian Voivodeship | 82-300 | Poland |
| Investigational Site Number :6160011 | Katowice | Silesian Voivodeship | 40-648 | Poland |
| Investigational Site Number :6420001 | Bucharest | 011461 | Romania |
| Investigational Site Number :6420009 | Bucharest | 030303 | Romania |
| Investigational Site Number :6420008 | Bucharest | 050159 | Romania |
| Investigational Site Number :6420003 | Cluj-Napoca | 400371 | Romania |
| Investigational Site Number :6420004 | Cluj-Napoca | 400371 | Romania |
| Investigational Site Number :6420007 | Constanța | 900002 | Romania |
| Investigational Site Number :6420006 | Timișoara | 300310 | Romania |
| Investigational Site Number :6420010 | Timișoara | 300310 | Romania |
| Investigational Site Number :6430003 | Chelyabinsk | 454091 | Russia |
| Investigational Site Number :6430004 | Kazan' | 420008 | Russia |
| Investigational Site Number :6430006 | Moscow | 105077 | Russia |
| Investigational Site Number :6430001 | Moscow | 115093 | Russia |
| Investigational Site Number :6430005 | Moscow | 115280 | Russia |
| Investigational Site Number :6430008 | Moscow | 115682 | Russia |
| Investigational Site Number :6430002 | Moscow | 117546 | Russia |
| Investigational Site Number :6430009 | Moscow | 125284 | Russia |
| Investigational Site Number :6430007 | Saint Petersburg | 193231 | Russia |
| Investigational Site Number :7030007 | Banská Bystrica | 97517 | Slovakia |
| Investigational Site Number :7030006 | Humenné | 066 01 | Slovakia |
| Investigational Site Number :7030003 | Levice | 93401 | Slovakia |
| Investigational Site Number :7030001 | Poprad | 058 01 | Slovakia |
| Investigational Site Number :7030002 | Spišská Nová Ves | 05201 | Slovakia |
| Investigational Site Number :4100003 | Wŏnju | Gangwon-do | 26426 | South Korea |
| Investigational Site Number :4100004 | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Investigational Site Number :4100008 | Incheon | Incheon-gwangyeoksi | 21431 | South Korea |
| Investigational Site Number :4100001 | Seoul | Seoul-teukbyeolsi | 03080 | South Korea |
| Investigational Site Number :4100009 | Seoul | Seoul-teukbyeolsi | 03312 | South Korea |
| Investigational Site Number :4100007 | Seoul | Seoul-teukbyeolsi | 05505 | South Korea |
| Investigational Site Number :7240096 | Santiago de Compostela | A Coruña [La Coruña] | 15706 | Spain |
| Investigational Site Number :7240002 | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Investigational Site Number :7240007 | Sant Boi de Llobregat | Barcelona [Barcelona] | 08830 | Spain |
| Investigational Site Number :7240005 | Mérida / Badajoz | Extremadura | 06800 | Spain |
| Investigational Site Number :7240006 | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Investigational Site Number :7240003 | Madrid | 28007 | Spain |
| Investigational Site Number :7240001 | Málaga | 29010 | Spain |
| Investigational Site Number :7240010 | Palma de Mallorca | 07120 | Spain |
| Investigational Site Number :7240004 | Valencia | 46015 | Spain |
| Investigational Site Number :7520001 | Lund | 221 85 | Sweden |
| Investigational Site Number :7520002 | Stockholm | 114 46 | Sweden |
| Investigational Site Number :7920004 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number :7920001 | Istanbul | 34098 | Turkey (Türkiye) |
| Investigational Site Number :7920006 | Izmir | 35040 | Turkey (Türkiye) |
| Investigational Site Number :7920007 | Izmir | 35110 | Turkey (Türkiye) |
| Investigational Site Number :7920008 | Kirikkale | 71450 | Turkey (Türkiye) |
| Investigational Site Number :7920005 | Manisa | 45000 | Turkey (Türkiye) |
| Investigational Site Number :7920002 | Mersin | 33070 | Turkey (Türkiye) |
| Investigational Site Number :8040003 | Chernivtsi | 58001 | Ukraine |
| Investigational Site Number :8040001 | Ivano-Frankivsk | 76018 | Ukraine |
| Investigational Site Number :8040006 | Kharkiv | 61166 | Ukraine |
| Investigational Site Number :8040004 | Kyiv | 02125 | Ukraine |
| Investigational Site Number :8040009 | Odesa | 65025 | Ukraine |
| Investigational Site Number :8040002 | Ternopil | 46000 | Ukraine |
| Investigational Site Number :8040005 | Vinnytsia | 21001 | Ukraine |
| Investigational Site Number :8040007 | Zhytomyr | 10002 | Ukraine |
| Derived |
| Ramakrishnan S, Petousi N, Bon J, Pavord ID, Bhatt SP, Rabe KF, Deng W, Xia C, Heble J, Soliman M, Couillard S. Win Ratio Analysis to Clarify Clinical Benefits: A Post Hoc Analysis of Phase 3 BOREAS and NOTUS (Two Pivotal Studies to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-Severe COPD With Type 2 Inflammation). Chest. 2026 Jul;170(1):76-87. doi: 10.1016/j.chest.2026.02.005. Epub 2026 Mar 5. |
| 40651490 | Derived | Christenson SA, Hanania NA, Bhatt SP, Bafadhel M, Rabe KF, Vogelmeier CF, Papi A, Singh D, Laws E, Dakin P, Bansal A, Lu X, Bauer D, Maloney J, Robinson LB, Abdulai RM. Type 2 inflammation biomarkers and their association with response to dupilumab in COPD (BOREAS): an analysis of a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):687-697. doi: 10.1016/S2213-2600(25)00044-X. Epub 2025 Jul 9. |
| 40024335 | Derived | Vogelmeier CF, Rabe KF, Bhatt SP, Hanania NA, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Maloney J, Dakin P, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces acute exacerbations and improves lung function in patients with COPD with type 2 inflammation irrespective of body mass index, airflow obstruction, dyspnea, and exercise capacity index scores. Respir Med. 2025 May;241:108015. doi: 10.1016/j.rmed.2025.108015. Epub 2025 Feb 28. |
| 39894389 | Derived | Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Abdulai RM, Robinson LB. Effect of Dupilumab on Health-Related Quality of Life and Respiratory Symptoms in Patients With COPD and Type 2 Inflammation: BOREAS and NOTUS. Chest. 2025 Jul;168(1):56-66. doi: 10.1016/j.chest.2025.01.029. Epub 2025 Jan 31. |
| 39481660 | Derived | Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Dakin P, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM. Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS). Respir Med. 2025 Jan;236:107846. doi: 10.1016/j.rmed.2024.107846. Epub 2024 Oct 30. |
| 37272521 | Derived | Bhatt SP, Rabe KF, Hanania NA, Vogelmeier CF, Cole J, Bafadhel M, Christenson SA, Papi A, Singh D, Laws E, Mannent LP, Patel N, Staudinger HW, Yancopoulos GD, Mortensen ER, Akinlade B, Maloney J, Lu X, Bauer D, Bansal A, Robinson LB, Abdulai RM; BOREAS Investigators. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 Jul 20;389(3):205-214. doi: 10.1056/NEJMoa2303951. Epub 2023 May 21. |
Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
| Safety Population | One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The Randomized population consisted of any participant who was allocated to a randomized treatment regardless of whether the treatment kit was used.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
| BG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | The intent-to-treat (ITT) population consisted of the randomized population analyzed according to the treatment group allocated by randomization. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) at Week 12 | The FEV1 was 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. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Week 12 |
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| Secondary | Change From Baseline in Pre-BD FEV1 at Week 52 | The FEV1 was 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. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Pre-BD FEV1 at Week 12 in Subgroup of Participants With Baseline Fractional Exhaled Nitric Oxide (FeNO) >=20 Parts Per Billion (Ppb) | FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 milliliter per second (mL/s) and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour. | The subgroup of participants with baseline FeNO >=20 ppb within the ITT population were included. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Week 12 |
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| Secondary | Change From Baseline in Pre-BD FEV1 at Week 52 in Subgroup of Participants With Baseline FeNO >=20 Ppb | FeNO is a demonstrated biomarker of type 2 airway inflammation in respiratory diseases. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s and reported in ppb. This assessment was conducted prior to spirometry and following a fast of at least 1 hour. | The subgroup of participants with baseline FeNO >=20 ppb within the ITT population were included. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Saint (St.) George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 | The SGRQ was 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, activity and impacts (psycho-social) as well as a total score. Global and domain scores range from 0 to 100, with 100 representing the worst possible health status and 0 indicating the best possible health status. Higher score indicates worse health status/heath related quality of life. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Week 52 |
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| Secondary | Percentage of Participants With SGRQ 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. Participants with improvement <4 points or with missing values were considered as non-responders. The percentage of participants who achieved a clinically meaningful response in SGRQ total score (reduction [improvement] by >=4 points)/responders are reported. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Evaluating Respiratory Symptoms (E-RS) in COPD (E-RS: COPD) RS-Total Score at Week 52 | The E-RS in COPD scale was a part of the exacerbations of chronic pulmonary disease tool (EXACT). It was a derivative instrument used to measure the effect of treatment on the severity of respiratory symptoms in stable COPD. E-RS: COPD RS-Total Score was derived based on weekly averages of daily assessed 11 respiratory symptom items contained in the 14-item EXACT questionnaire. The RS-Total score represented overall respiratory symptom severity, ranged from 0 to 40. Summation procedure was used to derive the three daily domain scores: 1). RS-Breathlessness (range 0-17), 2) RS-Cough and Sputum (score range 0-11), 3) RS-Chest Symptoms (score range 0-12). The higher the score, more severe were the symptoms. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) to Week 52 |
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| Secondary | Annualized Rate of Moderate or Severe COPD Exacerbation Over the 52-Week Treatment Period in Subgroup of Participants With Baseline FeNO >=20 Ppb | Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 among participants with baseline FeNO >=20 ppb was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | The subgroup of participants with baseline FeNO >=20 ppb within the ITT population were included. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Baseline (Day 1) to Week 52 |
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| Secondary | Change From Baseline in Pre-BD FEV1 to Weeks 2, 4, 8, 24, 36 and 44 | The FEV1 was 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. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Weeks 2, 4, 8, 24, 36 and 44 |
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| Secondary | Change From Baseline in Post-BD FEV1 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-BD FEV1 referred to the spirometry performed within 30 minutes after administration of bronchodilator. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52 |
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| Secondary | Change From Baseline in Pre-BD Forced Expiratory Flow at 25 Percent (%) to 75% (FEF 25-75%) of Forced Vital Capacity (FVC) to Weeks 2, 4, 8, 12, 24, 36, 44, and 52 | FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters/second | Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36, 44 and 52 |
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| Secondary | Change From Baseline in Post-BD FEF 25-75% to Weeks 2, 4, 8, 12, 24, 36 and 52 | FEF is the amount of air (in liters) which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF 25-75% was defined as the mean FEF between 25% and 75% of the FVC, where FVC was defined as the volume of air (in liters) 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. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. Only those participants with data available were analyzed. | Posted | Least Squares Mean | Standard Error | liters/second | Baseline (Day 1) to Weeks 2, 4, 8, 12, 24, 36 and 52 |
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| Secondary | Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period | Moderate exacerbations were recorded by the Investigator and defined as AECOPD 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 requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting 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 exacerbations that occurred during the treatment period divided by the total number of participant-years treated. Events were adjudicated by independent third party. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. | Posted | Number | 95% Confidence Interval | exacerbation per participant-year | Baseline (Day 1) to Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Moderate or Severe COPD Exacerbation 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. The median time to first severe exacerbation was derived from Cox regression model. Moderate exacerbations events were recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, or observation for >24 hours in an emergency department/urgent care facility or resulting in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. | The ITT population consisted of the randomized population analyzed according to the treatment group allocated by randomization. | Posted | Median | 95% Confidence Interval | weeks | Baseline (Day 1) and up to Weeks 12, 24, 36 and 52 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TE period which was defined as the period from the time of first dose of study treatment until the last visit in the study. Serious adverse events (SAE) were 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 or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. | The Safety population consisted of all participants who actually received at least 1 dose or partial of a dose of the study treatment, analyzed according to the treatment participants actually received. One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used. | Posted | Count of Participants | Participants | No | TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) to Dupilumab | Number of participants with treatment-emergent response to dupilumab with peak post-baseline titers during the on-treatment period are reported. Treatment-emergent response was defined as a positive response in the ADA assay post first dose, when baseline results were negative or missing. Categories were based on titer values and included: low (Titer <1000); moderate (1000<=Titer<=10,000); and high (Titer >10,000). On-treatment period was defined as last study treatment administration plus 14 days; that is, Week 52. | The ADA population consisted of all participants in the Safety population with at least 1 reportable ADA results (either 'ADA negative' or 'ADA positive') after first dose of the study treatment. | Posted | Count of Participants | Participants | No | Up to Week 52 |
|
TEAEs were collected from the time from the first administration of study treatment to the last administration of the study treatment + 98 days, up to 491 days
Analysis was performed on the Safety population. One participant was exposed to different treatment other than planned (was randomized to placebo arm but received dupilumab on Day 40). The actual arm was considered as dupilumab 300 mg q2w. In safety analyses, the actual arms are used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to dupilumab 300 mg as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). | 9 | 470 | 74 | 470 | 172 | 470 |
| EG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). | 8 | 469 | 65 | 469 | 168 | 469 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Wall Abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchitis Bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Ductal Adenocarcinoma Of Pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung Carcinoma Cell Type Unspecified Stage Iv | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anaphylactic Reaction | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Basal Ganglia Haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cor Pulmonale Acute | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nodal Rhythm | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertensive Emergency | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral Artery Occlusion | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral Vascular Disorder | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal Polyp | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatorenal Syndrome | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sudden Cardiac Death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax Traumatic | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Skin Abrasion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2020 | Jan 30, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level. |
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| OG001 | Dupilumab 300 mg q2w | Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52). |
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